Cognitive-behavioral therapy for HIV medication adherence and depression

Cognitive-behavioral therapy for HIV medication adherence and depression

415 Cognitive-Behavioral Therapy for HIV Medication Adherence and Depression Steven A. Safren, Massachusetts General Hospital a n d H a r v a r d Med...

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Cognitive-Behavioral Therapy for HIV Medication Adherence and Depression Steven A. Safren, Massachusetts General Hospital a n d H a r v a r d Medical School a n d Fenway Community Health, Boston Ellen S. H e n d r i k s e n , Fenway Community Health, Boston K e n n e t h H. Mayer, Brown University a n d Miriam Hospital, Providence, R I MatthewJ. Mimiaga a n d R o b e r t Pickard, Fenway Community Health, Boston Michael W. Otto, Massachusetts General Hospital a n d H a r v a r d Medical School For patients with HIV,, depression is a common, distressing condition that can interfere with a critical self-carebehavior-- adherence to antiretroviral therapy. The present study describes a cognitive-behavioral treatment designed to integrate cognitive-behavioral therapy for depression with our previously tested approach to improving adherence to antiretroviral therapy for HI~. Each session addresses HIV medication adherence in the context of modules for activity scheduling, cognitive restructuring, problem-solving training, and relaxation training~diaphragmatic breathing. We present the design of the intervention and outcome of 5 cases. All of the patients ])resented below were men who have sex with men who were infected with HIV through sexual transmission. Generally, these patients showed improvements in both depression and medication adherence.

EPRESSIONis a common yet debilitating problem for patients infected with HIM. Prospective cohort studies, as well as community-based convenience samples, suggest rates of depressive disorders in patients with HIV as high as 37% (e.g., Atkinson & Grant, 1994; Dew et al., 1997; Rabkin, 1996), and studies of patients in primary care clinics have found rates of approximately 20% (Lyketsos, Hanson, Irishman, McHugh, & Treisman, 1994). The high frequency of diagnosable depression in this population may be in part due to the multiple stressors involved with living with HIV infection and maintaining a regimen of antiretroviral therapy (Kalichrnan, Ramachandran, & Ostrow, 1998; Kelly, Otto-Salaj, Sikkema, Pinkerton, & Bloom, 1998). Although antidepressant treatment is common in patients with HIV, in clinical trials it is generally estimated that as few as 50% of patients treated with antidepressants are treatment responders (e.g., Agency for Health Care Policy and Research, 1993a, 1993b; Fava, Alpert, Nierenberg, Worthington, & Rosenbaum, 2000; Fava & Davidson, 1996), and that of those who do respond, only 50% to 65% attain remission versus symptom reduction only. Medication adherence is particularly important for the successful treatment of HIV (e.g., Besch, 1995; Carpenter et al., 2000; Ickovics & Meisler, 1997). Poor adherence is associated with poor medical outcome as measured by viral load or CD4 cell count (e.g., Bangsberg et al., 2000; Catz, Kelly, Bogart, Benotsch, & McAuliffe, 2000; Gifford et al., 2000; Hecht, Colfax, Swanson, & Chesney,

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Cognitive and Behavioral Practice 1 1 , 4 1 5 - 4 2 3 , 2004

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1998). Several studies using data from electronic pill caps as indicators of adherence have found significant associations between adherence and improved viral load status (Montaner et al., 1998; Paterson et al., 2000; Stansell et al., 2001). Paterson et al. (2000), for example, found significant laboratory differences between groups of patients who had over 95% adherence and those who had 80% to 94.9% adherence. In the former group, 78% of patients achieved an undetectable viral load, compared to only 49% of the latter group. In the field of behavioral medicine, depression is associated with worse medical outcomes. A recent meta-analysis revealed that depressed patients are three times greater than nondepressed patients to be noncompliant with medical treatment recommendations (Dimatteo, Lepper, & Croghan, 2000). For HIV in particular, several studies have recently revealed a similar association between adherence to antiretroviral medications and symptoms or diagnosis of depression (Catz et al., 2000; Gordillo, del Amo, Soriano, & Gonzalez-Lahoz, 1999; Holzemer et al., 1999; Paterson et al., 2000; Safren et al., 2001; Singh et al., 1996). The link between depression and poor adherence may be a result of mood-related impairments (low energy, decreased interest, concentration problems, low motivation) on problem-solving and coping abilities (see Safren, Radomsky, Otto, & Salomon, 2002). However, it is also important to note that depression may have direct effects on HIV outcomes: one recent study found an association between depression and CD4 count after statistically controlling for viral load, a potential indicator of adherence (Evans et al., 2002). Taken together, this area of research suggests that depression may have effects on H1V disease progression

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Safren et al. b o t h directly a n d by its association with i m p a i r e d problem solving a n d worse a d h e r e n c e to medications. We therefore hypothesized that treating depression and p o o r HIV m e d i c a t i o n a d h e r e n c e u s i n g c o g n i t i v e - b e h a v i o r a l therapy may have direct and indirect effects on the health o f individuals with HIV a n d depression. T h e c o m b i n e d t r e a t m e n t o f these conditions offers the benefit o f amelioration of d e p r e s s i o n symptoms that n o t only i m p a i r adh e r e n c e b u t also may i m p a i r the ability o f d e p r e s s e d patients to adequately attend to, engage in, a n d benefit from the a d h e r e n c e intervention itself. In a d d i t i o n to the direct, potential benefits this t r e a t m e n t offers to HIV patients, a validated psychosocial intervention for depression in the c o n t e x t o f HIV may have implications for the t r e a t m e n t o f depression in the c o n t e x t o f o t h e r c h r o n i c o r terminal illnesses. Developing a n d validating a psychosocial intervention requires several steps. Ronsaville, O n k e n , a n d colleagues (see O n k e n , Blaine, & Battjes, 1997; Rounsaville, Carroll, & O n k e n , 2001) p r o p o s e d a m o d e l of psychosocial intervention steps analogous to clinical d r u g trials that denotes specific tasks from conceptualizing the treatment, to pilot testing, to efficacy r e s e a r c h , a n d finally to effectiveness studies. Accordingly, before u n d e r t a k i n g a r a n d o m i z e d c o n t r o l l e d efficacy study, Stage 1 should involve activities such as conceptualizing the treatment, m a n u a l writing, pilot a n d feasibility testing. T h e p r e s e n t p r o j e c t describes the results o f o u r Stage 1 activities in developing a n d beginning to test a cognitive-behavioral intervention for H1V medication a d h e r e n c e a n d treatment-resistant depression patients. The patients are considered treatment-resistant because they have c o n t i n u e d to be depressed despite antidepressant treatment, c o n t i n u e to have a detectable viral l o a d despite antiretroviral therapy for HIV, a n d r e p o r t difficulties a d h e r i n g to their m e d i c a t i o n regimen.

D e s c r i p t i o n o f C o g n i t i v e - B e h a v i o r a l Therapy for HIV M e d i c a t i o n A d h e r e n c e a n d D e p r e s s i o n Cognitive-behavioral therapy for HIV m e d i c a t i o n adh e r e n c e a n d depression is based o n traditional CBT app r o a c h e s to the t r e a t m e n t of depression c o m b i n e d with i n t e r v e n t i o n techniques most applicable to persons with chronic illness in general a n d HIV in particular (see Nezu, Nezu, Friedman, Faddis, & Hours, 1998; Nezu, Nezu, F r i e d m a n , Hours, & Faddis, 1997; T h o m a s o n , Bachanas & Campos, 1996). The components include a single-session i n t e r v e n t i o n d e d i c a t e d exclusively to H I V m e d i c a t i o n a d h e r e n c e (Life-Steps; Safren et al., 2001; Safren, Otto, & Worth, 1999) ; an i n t r o d u c t o r y CBT session involving motivational interviewing a n d p s y c h o e d u c a t i o n a b o u t depression a n d H1V; a n d m o d u l e s involving activity scheduling, cognitive restructuring, problem-solving training, a n d training in relaxation a n d d i a p h r a g m a t i c breathing.

T h e start o f every session includes an assessment a n d discussion o f H1V m e d i c a t i o n a d h e r e n c e a n d c u r r e n t m o o d . T h e a d h e r e n c e c o m p o n e n t to the t r e a t m e n t was based b o t h on o u r e x p e r i e n c e with a r a n d o m i z e d controlled trial of Life-Steps (the single-session a d h e r e n c e intervention; Safren et al., 1999; Safren et al., 2001) a n d with o u r e x p e r i e n c e c o n d u c t i n g a r a n d o m i z e d controlled trial o f a p a g e r system to increase HIV m e d i c a t i o n a d h e r e n c e (Safren, H e n d r i k s e n , DeSousa, Boswell, & Mayer, 2003). The suggested sequence of modules is presented below; however, we have delivered the m o d u l e s in different sequences d e p e n d i n g on p a t i e n t need. Each session is designed to b u i l d on previous skills a n d begins with a discussion o f skills for a d h e r e n c e to m e d i c a t i o n s as well as a review of skills discussed a n d l e a r n e d in previous modules.

Module 1: Adherence Training and Overview of CBT (2 Sessions) Cognitive-behavioral therapy for HIV medication adherence a n d depression has two m a j o r goals: (a) increased self-care, thus l e a d i n g to l o n g e r life a n d d e c r e a s e d morbidity, a n d (b) d e c r e a s e d depression. We t h e r e f o r e start by providing skills for H1V m e d i c a t i o n a d h e r e n c e , which are revisited as the t r e a t m e n t o f depression is i n t r o d u c e d and the patient's m o o d improves. Life-Steps. T h e first session, called Life-Steps ( m o r e fully described in Safren et al., 1999), is an intervention specifically d e s i g n e d for HIV m e d i c a t i o n a d h e r e n c e which can also be used on its own for that purpose. It is based on g e n e r a l principles o f cognitive-behavioral therapy as welt as m o r e specific principles of problem-solving t h e r a p y (D'Zurilla, 1986; Nezu & Perri, 1989). Eleven informational, problem-solving, and cognitive-behavioral steps are targeted. The first, psychoeducation a n d motivational interviewing, can b e a u g m e n t e d by a v i d e o t a p e p r e s e n t a t i o n o r o t h e r e d u c a t i o n a l materials. T h e psyc h o e d u c a t i o n a l c o m p o n e n t involves t e a c h i n g p a t i e n t s a b o u t t h e issue o f m e d i c a t i o n resistance, c o v e r i n g t h e following points: 1. H1V replicates very quickly. 2. W h e n HIV replicates it can also mutate, sometimes into a form that would be resistant to o n e ' s c u r r e n t o r future medications. 3. Full a d h e r e n c e to medications can stop replication to the p o i n t that the virus is n o t detectable by most measures (this is called viral suppression or having an u n d e t e c t a b l e viral load). W h e n a p a t i e n t is fully a d h e r e n t , the chances of s t o p p i n g viral replication are maximized. 4. If a p a t i e n t is only partially a d h e r e n t , the virus can still replicate. Because some (but n o t all) of the medicines are in o n e ' s bloodstream, the surviving copies

HIV and Depression are m o r e likely to be the ones that would be resistant to the medications. 5. Therefore, sometimes taking only p a r t o f one's regi m e n can have complications that m i g h t be even worse than taking no m e d i c i n e s whatsoever. After the psychoeducational i n f o r m a t i o n is presented, the c o u n s e l o r a n d p a t i e n t go t h r o u g h t h e following problem-solving steps: transportation to appointments, o b t a i n i n g m e d i c a t i o n s , c o m m u n i c a t i o n with providers, c o p i n g with side effects, formulating a daily m e d i c a t i o n schedule, storage of medications, cues for pill-taking, guided i m a g e r y review o f successful a d h e r e n c e in r e s p o n s e to daily cues, responses to slips in a d h e r e n c e , a n d review o f procedures. In each step, patients a n d the clinician define the p r o b l e m , g e n e r a t e alternative solutions, make decisions a b o u t the alternatives, a n d make a plan a b o u t how to i m p l e m e n t solutions. Introduction to CBTfor depression. T h e second session o f this m o d u l e involves o r i e n t i n g the p a t i e n t to cognitivebehavioral therapy for depression a n d the effect o f depression on self-care behaviors. T h e therapist elicits cognitive (negative thoughts a n d beliefs), behavioral (e.g., avoidance o f activities that elicit pleasure o r mastery, avoidance o f activities that require effort b u t are related to self-care), a n d physiological (sleep, appetite, low energy) symptoms a n d maps o u t a m o d e l o f how these symptoms are cyclical. In HIV, two relevant side effects of medicines o r disease-related symptoms that may exacerbate depression are (a) d e c r e a s e d activity a n d lack o f structure during the week ( d u e to weakness a n d d e p e n d i n g on the severity o f one's illness) a n d (b) the e x a c e r b a t i o n or elicitation o f symptoms (fatigue, c o n c e n t r a t i o n difficulties, b o d y aches a n d pains, low energy) that are r e m i n i s c e n t o f depression. In addressing the cognitive-behavioral m o d e l of depression within the c o n t e x t o f HIV, the therapist sets the stage for a discussion o f how each o f the interventions in the t r e a t m e n t attack this cycle. After a g e n e r a l orientation, the n e x t intervention uses motivational interviewing (MI; Miller & Rollnick, 1991) to e x a m i n e the i m p a c t o f depression on the patient's life. Therapists lead a discussion o f the potential effects of depression on self-care, m e d i c a t i o n adherence, and o t h e r functional impairments. T h e pros a n d cons o f i n t e r v e n ing to change these patterns are discussed and, p e n d i n g signs o f motivation for treatment, the therapist presents the e l e m e n t s o f t r e a t m e n t in this p r o g r a m , h i g h l i g h t i n g those that are most relevant to the areas o f i m p a i r m e n t previously discussed. Overall, the goal o f this session is to instill a sense of o p t i m i s m for future c h a n g e by providing a m o d e l o f depression that is directly relevant to the patient, a n d by explaining how the different m o d u l e s of t r e a t m e n t can h e l p the p a t i e n t m a k e changes to his or h e r life situation.

Module 2: Behavioral Activation (1 Session) T h e advent o f antiretroviral t h e r a p y has allowed individuals with HIV to live longer, thus c h a n g i n g HIV from a terminal illness to o n e o f a chronic nature. Because antiretroviral t h e r a p y is still relatively new, individuals suffering with HIV for m a n y years, who may have previously viewed t h e i r d e a t h as i m m i n e n t , are now faced with a l o n g e r life where they must chronically m a n a g e a difficult a n d c o m p l e x m e d i c a t i o n r e g i m e n while at times f e e l i n g ill. F u r t h e r m o r e , s o m e p a t i e n t s with H1V a n d d e p r e s s i o n will b e o n disability, w h i c h can l e a d to a n a b s e n c e o f s t r u c t u r e d u r i n g the day a n d t h e a b s e n c e o f events that involve feelings o f mastery or pleasure. O t h e r p a t i e n t s m a y suffer f r o m i s o l a t i o n o r may have withd r a w n f r o m p a r t i c i p a t i n g in activities t h a t they previously enjoyed, such as hobbies or going out with friends. Consequently, the structuring o f pleasurable events may b e a p a r t i c u l a r l y i m p o r t a n t i n t e r v e n t i o n for m a n y HIVpositive p a t i e n t s . This m o d u l e involves having participants l e a r n to identify times a n d situations w h e n they are m o r e a n d less likely to feel d e p r e s s e d due to their relative involvement o r lack o f involvement in pleasurable activities. W i t h the use o f a positive-events checklist, participants will identify activities that involve pleasure or mastery. Participation in these events provides evidence against negative automatic thoughts a n d beliefs. A t t e n t i o n to a d h e r e n c e a n d schedu l i n g o f pill-taking is included. As m u c h as possible, pardcipants will be e n c o u r a g e d to find regularly o c c u r r i n g activities, i n c l u d i n g (but n o t limited to) social events, volunteering, a n d regular involvement in a d d i t i o n a l supportive organizations a n d groups. A l t h o u g h this session is d e d i c a t e d specifically to behavioral activation, all future sessions have time d e d i c a t e d to reviewing this issue a n d relevant progress.

Module 3: Cognitive Restructuring (5 Sessions) Cognitive restructuring is also a key e l e m e n t o f treatm e n t for depression (A. Beck, 1987;J. Beck & Beck, 1995). In o u r protocol, p r o c e d u r e s are similar to those typically e m p l o y e d in cognitive interventions e x c e p t that they acc o u n t for specific issues r e l a t e d to H1V a n d to m e d i c a t i o n a d h e r e n c e . Five sessions are reserved for cognitive restructuring, a n d at least some cognitive restructuring efforts are devoted to progress in activity s c h e d u l i n g - h e l p i n g p a t i e n t s a d d r e s s activity goals t h a t m a y be avoided because of negative a u t o m a t i c thoughts or core beliefs. F o r example, if negative automatic thoughts o r beliefs cause patients to avoid activity scheduling, cognitive restructuring can target potential new activities. Cognitive restructuring can be a p p l i e d to HIV m e d i c a t i o n adh e r e n c e in that m a n y individuals have negative a u t o m a t i c thoughts a b o u t the pills that they have to take (i.e., "They r e m i n d m e that I a m sick"). It can also be a p p l i e d to

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Safren et al. issues surrounding living with HIV, such as "survivor guilt" from having lost friends or loved ones to the illness, or p u n i s h m e n t beliefs about HIV.

Assessments

Module 4: Problem Solving (2 Sessions)

The clinician-administered assessments occurred before treatment and after treatment. The Structured Clinical Interview for DSM-IV (SCID-IV; First, Spitzer, Gibbon, & Williams, 1995) was used as the diagnostic assessment for DSM-1V (American Psychiatric Association, 1994) Axis I psychiatric disorders. The clinician also completed the Structured Version (Williams, 1988) of the Hamilton Depression Scale (HAM-D; Hamilton, 1959), which is the most widely used clinical measure of depression in psychiatric research a n d has a d e q u a t e psychometric reliability and validity. For the purposes o f this project, the first 17 items on the HAM-D were used. O n the basis o f these assessments, the clinician rated global severity using the Clinical Global Impression (CGI; National Institute of Mental Health, 1985) for severity (1 = not ill, to 7 = extremely ill) and the Global Assessment of Functioning (GAF; A m e r i c a n Psychiatric Association, 1994). T h e GAF is the DSM-IVAxis V rating, r a n g i n g f r o m 1 to 100.

Problem-solving training in this p r o t o c o l involves learning two major skills that are targeted to reducing avoidance of important tasks: (a) breaking overwhelming tasks into manageable steps and (b) learning techniques to make informed decisions. These skills are drawn from problem-solving therapy (D'Zurilla, 1986; Nezu & Perri, 1989), which has specific application to coping with chronic illness (Nezu et al., 1997). Elements of problem-solving interventions include defining the problem, generating alternatives, evaluation of alternatives, decision making, and solution implementation. In HIV, some typical targets for problem solving can include negotiating issues about working or volunteering, negotiating the healthcare system, managing one's finances given a fixed income, and relationship concerns.

Module 5: Relaxation Training (2 Sessions) Progressive muscle relaxation and diaphragmatic breathing are key components to anxiety m a n a g e m e n t and stress reduction programs. They are also widely used in behavioral medicine approaches to coping with body pain, headache, and nausea (Cotanch, 1983; Smith, 1987; Turner & Chapman, 1982), all of which can be side effects of HIV medications a n d / o r symptoms of HIV disease. Diaphragmatic breathing is taught to help patients relax during times of stress and cope with symptoms. With the help of the therapist, the participant will make a relaxation tape that includes training in cue-controlled relaxation.

Case Series Study of CBT for HIV Medication A d h e r e n c e and D e p r e s s i o n Participants Individuals eligible for the study were those who met diagnostic criteria for major depressive disorder as their principal diagnosis, had been on stable antidepressant medications for 6 weeks, stable antiretroviral therapy for HIV for 4 months, had a detectable viral load (verified by blood draw), and were over the age of 18. Excluded patients were those with a bipolar or psychotic spectrum disorder j u d g e d to interfere with the treatment or ability to understand or give informed consent. Also excluded were patients who are acutely suicidal and require immediate hospitalization or additional care. Five patients, all of whom were men who have sex with men who were infected with HIV t h r o u g h sexual transmission, provided inf o r m e d consent, were treated openly, and completed the following assessments.

Clinician-Administered Assessments of Diagnosis and Severity

Participant Measures Electronic pill cap. We used an electronic pill-cap, which was attached to a pill bottle for the antiretroviral medication that was most difficult to r e m e m b e r (for participants who reported they were equal in difficulty of remembering, they used the cap for the pill that they took most frequently). Adherence scores were calculated by dividing the n u m b e r of doses taken ( n u m b e r of times pill cap registered being opened) by the n u m b e r of prescribed doses. A dose was considered missed if it was not taken or if it was taken more than 2 hours from the designated time. Before starting treatment, individuals monitored their medication with the electronic pill-cap for 2 weeks. At each treatment session, the pill cap was read, and participants received feedback about their adherence for the previous week. Depression. Participants completed the self-report Beck Depression Inventory (BDI; Beck, Ward, Mendelson, Mock, & Erbaugh, 1961) at each therapy session. The BDI has a strong history of psychometric reliability and validity and is widely used in psychiatric research. Adherence Questionnaire. Self-report supplemented the electronic pill-cap data. The Adherence Questionnaire is a straightforward instrument that asks patients to record the n u m b e r of pills prescribed and the n u m b e r of pills taken each day over a specified time period. This measure is utilized in AIDS Clinical Trials Group research (Chesney et al., 2000) and asks about "yesterday," "the day before yesterday," and "the past 4 days." We adapted the time frame to also include "the past week" and "the past 2 weeks" to match the time-frame of the electronic pill-cap data. Par-

HIV and Depression ticipants c o m p l e t e d the a d h e r e n c e q u e s t i o n n a i r e at the b e g i n n i n g a n d e n d of treatment. Assessment of viral load. At the evaluation a n d posttreatm e n t assessment, participants h a d their b l o o d drawn for a viral l o a d assessment. If they h a d their b l o o d drawn within 2 weeks, however, we r e q u e s t e d a release of inform a t i o n a n d o b t a i n e d the results from their physician. Successful response to antiretroviral t h e r a p y can b e defined as m a i n t e n a n c e o f a plasma viral l o a d below the limits o f d e t e c t i o n in patients who h a d b e e n on the same antiretroviral r e g i m e n for 6 months, or at least a one log d r o p in plasma viral load within 1 m o n t h o f c h a n g i n g antiretroviral regimens ( C a r p e n t e r et al., 2000). Procedure

Participants c o m p l e t e d the diagnostic interview, viral load assessment, HAM-D, a n d A d h e r e n c e Q u e s t i o n n a i r e at the first study visit a n d after c o m p l e t i o n of the treatment. T h e cognitive-behavioral t r e a t m e n t consisted o f 10 to 12 sessions o f cognitive-behavioral t h e r a p y for HIV m e d i c a t i o n a d h e r e n c e as d e s c r i b e d above. D u r i n g the course o f the treatment, participants m o n i t o r e d their adh e r e n c e to one o f their antiretroviral m e d i c a t i o n s using an electronic pill-cap, which was r e a d weekly, a n d comp l e t e d the BDI weekly. At the c o m p l e t i o n o f treatment, they r e p e a t e d the clinician-administered assessments) Case Series Results

Baseline Participant Characterist~¥s A b r i e f description of each o f the five participants is p r o v i d e d below in o r d e r to provide a picture o f the types of individuals who p r e s e n t e d for treatment. M u c h o f the i n f o r m a t i o n has b e e n o m i t t e d in o r d e r to p r o t e c t confidentiality. All individuals were m e n who have sex with m e n , a n d all r e p o r t e d that they c o n t r a c t e d HIV sexually. We do n o t r e p o r t extensive clinical a n d p e r s o n a l inform a t i o n in o r d e r to p r o t e c t confidentiality. T h e first p a r t i c i p a n t was an African A m e r i c a n male in his m i d 4 0 s with m a j o r depressive d i s o r d e r (CGI 6; "severely ill, m a j o r i m p a i r m e n t in school, work, family relations, suicidal ideations") a n d alcohol d e p e n d e n c e (CGI 5), a n d a HAM-D score o f 34. H e r e p o r t e d that he h a d n o t taken any of his medications over the past two weeks, with the m a i n reason b e i n g that he h a d too m a n y pills to 1 On e therapist completed all of the baseline evaluations and the therapy sessions. For two of the participants (Cases 4 and 5), an ind e p e n d e n t assessor completed the posttreatment assessments. For another two, although the therapist did the posttreatment interviews that involved the SCID and the HAM-D, an i n d e p e n d e n t assessor rated audiotapes of these assessments for the case-series outcome data presented below (therapist rating was used for the observational item). Audiotape ratings were not available for one participant's posttreatment assessment, or the three participants' pretreatment assessments that were conducted before we had funding for an i n d e p e n d e n t assessor.

take. H e h a d b e e n HIV-positive for a p p r o x i m a t e l y 10 years, h a d previously worked in f o o d p r e p a r a t i o n , b u t he lost his j o b a r o u n d the time that he was infected. H e reports that he h a d b e e n hospitalized in the past for emotional p r o b l e m s a n d h a d also b e e n homeless. At the time of treatment, h e was living alone in subsidized (Section 8) h o u s i n g a n d his p r i m a r y source o f i n c o m e was disability. H e r e p o r t e d that aside from a p p o i n t m e n t s , he s p e n t most o f his time by himself in his h o m e . With r e s p e c t to HIV, he was o n a "salvage" (salvage t h e r a p y is w h e n multiple agents are used after successive failure o f first- a n d second-line treatments) regimen, having failed several o t h e r r e g i m e n s (possibly because o f p o o r a d h e r e n c e ) a n d was now taking f o u r different H1V m e d i c a t i o n s at various times d u r i n g the day. T h e s e c o n d p a r t i c i p a n t (Case 2) was a white m a l e in his early 30s who w o r k e d full-time b u t suffered from m a j o r depression (CGI 6; "severely ill, m a j o r i m p a i r m e n t in school, work, family relations, suicidal ideations"), dysthymia (CGI 4), a n d social p h o b i a (CGI 5). H e also end o r s e d symptoms o f generalized anxiety disorder, however, this could n o t be d i a g n o s e d because o f o v e r l a p p i n g m o o d disorders. This individual h a d b e e n diagnosed with HIV for a p p r o x i m a t e l y 5 years, a n d m a j o r stressors involved significant debt, an unsatisfying j o b , a n d social isolation when n o t at work. H e was taking triple combination therapy for HIV, h a d a d d i t i o n a l c o m o r b i d medical conditions, a n d r e p o r t e d sporadic a d h e r e n c e to b o t h his H1V a n d o t h e r medical t r e a t m e n t conditions. Case 3 was a white male in his late 40s. H e m e t criteria for m a j o r depressive d i s o r d e r (CGI 6; "severely ill, m a j o r i m p a i r m e n t in school, work, family relations, suicidal ideations"), c o n c u r r e n t dysthymic d i s o r d e r (CGI 5), a n d social p h o b i a (CGI 3), with a baseline HAM-D score o f 30. H e r e p o r t e d that he h a d taken all of his pills over the previous 2 weeks, b u t h a d taken some late. A l t h o u g h h e h a d previously w o r k e d in administrative positions, he was also u n e m p l o y e d , b u t lived with his p a r t n e r in subsidized housing, as his p r i m a r y source o f income. This p a t i e n t also r e p o r t e d that h e h a d HIV for over 10 years a n d was on a "salvage" t r e a t m e n t r e g i m e n consisting o f 5 differe n t antiretroviral m e d i c a t i o n s to be taken at various times d u r i n g the day. Significant life stressors i n c l u d e d relationship p r o b l e m s a n d financial problems. T h e fourth p a r t i c i p a n t openly treated in this study was an African A m e r i c a n m a n in his late 40s who h a d b e e n H1V-positive for 14 years. H e was currently living with his p a r t n e r a n d was working part-time in an administrative position, b u t his m a i n source o f i n c o m e was disability. H e h a d recently h a d a suicide a t t e m p t (3 m o n t h s p r i o r to his baseline evaluation) a n d was hospitalized. H e felt that his d e p r e s s e d m o o d was his most significant p r o b l e m (CGI of 5, "markedly ill, f u n c t i o n i n g with passive suicidal ideation"); however, he also m e t diagnostic criteria for panic

419

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Safren et al.

Table 1 Electronic Pill-Cap A d h e r e n c e Pre a n d Post S c o r e s Case

Pretreatment

Posttreatment

1

14%

Did n o t use pillcap

2 3

64% 88%

93% 100%

4 5

21% 89%

93% 92%

disorder, OCD, acrophobia, and had a history- of alcohol abuse. His initial Hamilton-17 depression rating scale score was 33, and his viral load 65,460. He reported that he only took about half of his HIV medications, generally because of forgetting, feeling depressed, or being busy. Major stressors involved his primary relationship, finances, symptoms, and pressures within his family of origin. The fifth participant had a somewhat different presentation than the previous four. This was a white male in his early 50s, relatively high socioeconomic status, and a graduate degree. Although he worked full time, had a good and stable relationship, and was relatively higher-functioning, he did meet criteria for major depressive disorder (CGI 4) and symptoms o f a d u h attention-deficit disorder (CGI 3). His viral load, 430, was just over the detectable range. His major stressor involved his work. Outcome of Case Series

Tables 1 and 2 have adherence scores using electronic pill cap and self-report respectively for each participant at the pretreatment and posttreatment assessments. In Figure 1, the first column presents the pill-cap adherence scores and the second column presents depression scores using the BDI. Table 3 presents depression CGI scores and HAMD (17 item) scores for each participant. Generally, selfreported adherence, adherence assessed with the electronic pill cap, and depression severity improved with treatment. According to the SCID-IV, only one of the five individuals presented still met DSM-/Vcriteria for major depression Case 1

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The primary outcome variable for this intervention was HIV medication adherence. We reasoned that the intervention would direcdy help with adherence as a result of specific adherence skills-training, and indirectly help adherence by treating depression, which was thought to interfere with i m p o r t a n t self-care behaviors (see Safren et al., 2001, 2002). Finally, we examined biological outcome with respect to the patient's viral load (see Table 4). Four of the five individuals completed the entire treatm e n t and both the pretreatment and posttreatment assessment. O n e individual (Case 1) discontinued participation from treatment after four sessions, but agreed to complete the posttreatment assessment. Adherence to antiretroviral medications was assessed with both self-report and with the electronic pill caps.

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F i g u r e 1. A d h e r e n c e (Electronic Pill Cap) a n d d e p r e s s i o n (Beck

D e p r e s s i o n Inventory) s c o r e s for e a c h participant.

HIV and Depression

Table 3

MDD Clinical Global Impression Scores and Hamilton Depression Scale Scores Pretreatment Case 1 2 3 4 5

Posttreatment

CGI

HAM-D

CGI

HAM-D

6 6 6 5 4

34 29 30 33 13

2 3 2 2 2

19 17 6 4 4

Note. CGI = Clinical Global Impression 1-7 scale (1 = not at all ill, 3 = mildly ill, 7 = among the most severely depressed patients) ; HAM-

D = Hamilton Depression Rating Scale (17 item) scores.

at the e n d of the treatment. This individnal had a relatively low CGI score (3 = mildly ill) posttreatment, a n d a clinically significantly higher o n e at p r e t r e a t m e n t (5 = markedly ill). A n additional participant had a n elevated HAM-D score at posttreatment, b u t this individual did n o t m e e t criteria for depression because he did n o t endorse persistent sadness or loss of interest as p r e s e n t i n g symptoms. All individuals made clinically significant improvements as evident by a drop in at least 2 CGI points from p r e t r e a t m e n t to posttreatment. I n terms of the profile of changes across treatment, Cases 2, 3, a n d 5 had relatively consistent i m p r o v e m e n t s in a d h e r e n c e as per the weekly electronic pill cap readings, a n d had c o n c u r r e n t decreases in their depression as evidenced by their weekly scores o n the BDI. Although each participant c o m p l e t e d all four of the modules of treatment, the emphasis differed across participants. For Case 2, a major part of the t r e a t m e n t involved h e l p i n g him use cognitive restructuring a n d p r o b l e m solving to reevaluate the cycle he was in with respect to his income. Although at first there was a slight decrease in depression a n d a d h e r e n c e over the first few visits, after Session 4 the patient had a medical setback, which resulted in increased depression a n d worse adherence. After negotiating this setback, depression scores decreased steadily a n d better a d h e r e n c e r e s u m e d (with a pill cap score of 93% at the posttreatment assessment), a n d the p a t i e n t made a decision to r e t u r n to school. Case 3 started with less t h a n 90% Table 4

Viral Load ScoresatPretreatment and Pos~reatment Case 1 2 3 4 5

Pretreatment

Posttreatment

101,600 920 150 65,460 430

172,000 771 180 298 120

421

a d h e r e n c e a n d had significant problems with his relationship when he e n t e r e d the treatment. Cognitive restructuring a n d p r o b l e m solving were key aspects of the treatment; in this respect, the p a t i e n t l e a r n e d to balance b e i n g able to do what he could for his partner, b u t also accepting w h e n he h a d d o n e all he could. With this, both he a n d his p a r t n e r were in a better situation at the e n d of the treatment, his a d h e r e n c e h a d improved to 100% for several weeks in a row, a n d his depression was m u c h improved. Case 5 had the highest a d h e r e n c e a n d lowest depression severity to start with. He, however, m a d e consistent improvements in both areas, with key aspects of cognitive restructuring targeting his view of himself at work. He also benefited from activity scheduling, resuming pleasurable events that he had sacrificed for workrelated activities. These three individuals h a d detectable b u t relatively low viral load scores at the start of treatm e n t , a n d the changes that o c c u r r e d by the e n d of treatm e n t were small. Case 1 was the most equivocal with respect to his outcome. He h a d extremely low a d h e r e n c e at baseline according to both self-report (0%) a n d the electronic pill cap (14%). Over the course of 3 m o n t h s he a t t e n d e d only four sessions a n d therefore did n o t complete tile full course of treatment. He reported that he used the pill-cap a n d r e s u m e d taking his medications d u r i n g the time between his second therapy visit a n d baseline. At this time, he also began to work o n one area of CBT for d e p r e s s i o n - activity s c h e d u l i n g - - a n d reported that his depression improved at each visit that he did attend. He, however, f o u n d it difficult to attend the sessions, and, despite multiple attempts at scheduling, rescheduling, providing transportation, a n d other r e c r u i t m e n t techniques, eventually d r o p p e d out. The five sessions that he did a t t e n d occurred over a period of 4 months. Given the dramatic difference between his pill cap, self-report, a n d viral load information, his o u t c o m e is equivocal at best. Case 4 represented the most dramatic i m p r o v e m e n t o n all three outcomes: adherence, depression, a n d viral load. This patient j o i n e d the study with a high HAM-D score, multiple Axis I diagnoses, a n d a high viral load. We worked o n all five modules of treatment, with cognitive restructuring a n d relaxation therapy b e i n g key to issues involving anger m a n a g e m e n t a n d "giving up" with respect to self-care a n d adherence. His adherence had strong improvements as the t r e a t m e n t progressed, a n d his depression decreased substantially according to both self-report a n d the Hamilton interview. Finally, his viral load was m u c h improved, starting at 65,460 a n d e n d i n g at only 298.

DISCUSSION

This project achieved several successful steps toward developing a n d validating a cognitive behavioral inter-

422

Safren et al.

v e n t i o n targeting medical a n d psychological problems for a treatment-refractory a n d complex population: HIVi n f e c t e d patients with a d h e r e n c e p r o b l e m s , c o n t i n u e d d e p r e s s i o n despite antidepressant treatment, a n d a detectable viral load despite antiretroviral therapy. The target population, therefore, is o n e that has both significant medical a n d psychological impairments. We described the approach, which involved integrating the health-related behavior (adherence) into a structured cognitive-behavioral t r e a t m e n t for depression, a n d presented 5 example cases to illustrate the potential for clinical benefit with this approach. All individuals reported improved depression a n d improved a d h e r e n c e as a result of the treatment, a n d better adherence, generally, was shown with a second, objective indicator (the electronic pill cap) in patients who completed the intervention. As this is a case series design, several limitations are noteworthy. First, the same therapist developed the treatm e n t a n d treated each patient. Hence, while this is a first step in developing the intervention, more research is n e e d e d regarding its generalizability to other therapists. Second, the c o n f o u n d of the passage of time a n d regression to the m e a n c a n n o t be ruled out regarding improvement. Most of the participants started with elevated depression a n d poor adherence, a n d we do n o t know if these issues would have resolved themselves without additional cognitive behavioral treatment, a n d h e n c e a randomized controlled trial is in progress. Third, although an i n d e p e n d e n t assessor was utilized for two of the posttreatment assessments, a n d an i n d e p e n d e n t assessor rated tapes of assessments for a n o t h e r two, the therapist was also the evaluator for the p r e t r e a t m e n t assessments, a n d was the evaluator (although sessions were taped a n d rerated) for three of the posttreatment assessments. Patients were n o t b l i n d e d to the e n d p o i n t s of interest (reduced depression a n d increased adherence) a n d the impact of d e m a n d characteristics is u n k n o w n . Use of the objective measure of a d h e r e n c e (the electronic pill cap) a n d validated self-report (BDI) a n d clinician-rated (HAM-D, done by trained assessors) assessments helps mitigate some of these limitations, a n d the positive results of the case series should be i n t e r p r e t e d as a base for further hypothesis testing a n d a possible clinical strategy for individuals who suffer from these or similar problems. Despite these limitations, a n d the limitations of any case-series study, a cognitive-behavioral therapy that integrates the t r e a t m e n t of depression with an approach to increasing a health-psychology behavioral outcome was shown to be acceptable, feasible, a n d of potential clinical i m p o r t a n c e in a medically a n d psychologically impaired sample of patients. O n e of the lessons from the study involved the n e e d for adaptability within the framework of a m a n u a l i z e d treatment. The heterogeneity a n d severity of medical a n d psychological problems called for creative

use of a structured manual. O n e way to deal with this involved using a n d i m p l e m e n t i n g each of the modules b u t employing flexibility with respect to the order a n d fitting the relevance to a particular patient problem. For example, patients would typically come in with a particular problem that had occurred over the course of the week. T h e therapist, therefore, would attempt to match the problem to one of the interventions in tile manual. Typically, p r o b l e m solving a n d cognitive restructuring could be employed, a n d the particular p r o b l e m could be used as an example. Setting an agenda for the session was key to the i m p l e m e n t a t i o n of this type of approach, a n d this is consistent with recent guidelines for cognitive therapy of depression (e.g., Young, Grant, & DeRubeis, 2003). A second issue relates to the potential for generMizability if the efficacy estimates for this i n t e r v e n t i o n are further supported in a controlled trial. For the present study, the three of the four participants who completed the project received their care at the same location that the study took place. The only patient who d r o p p e d out did n o t receive care at this location, a n d o n e participant completed who also did n o t receive care at this location. Intensive efforts were made to retain these individuals in the study. R e m i n d e r calls were made the evening before, scheduling was f l e x i b l e - - a n d sometimes would change the day of the a p p o i n t m e n t , and, for patients with transportation problems, we provided taxi vouchers in order to assure attendance. If the i n t e r v e n t i o n continues to show efficacy, the question of cost will certainly come into play. Because a d h e r e n c e is critical to the t r e a t m e n t of HIV, a n d p r o p e r a d h e r e n c e optimizes the chances of a suppressed viral load, possibly allowing for the r e d u c e d likelihood of transmission of HIV (see Q u i n n et al., 2000), these issues all should be evaluated with respect to the calculation of the costs a n d benefits.

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chronic pain: A critical review.Relaxation and biofeedback. Pain, 1Z 1-21. Williams,J. B. (1988). A structured intmwiewguide for the Hamilton Depression Rating Scale.Archivesof GeneralPsyehiatry, 45, 742-747. Young,R R., Grant, E, & DeRubeis,R.J. (2003). Some lessonsfrom the group supervision of cognitive therapy for depression. Cognitive and BehavioralPractice, 10, 30-40. Fundingfor this project was from a Center For AIDSResearch (CFAR) Junior Investigator Developmental Award to Dr. Steven A. Safren funded by NIAID (through BruceWalker, MD, Principal Investigatorof the Pamaers/Fenway/Shattuck Center for AIDS Research; P30 ,~d42851). This project was also partially supported by NIMH 66660 awarded to Dr. Safren. Address correspondence to Steven A. Safren, Research and Evaluation Department, Fenway Community Health, 16 Haviland Street, Boston, MA 02115; e-mail:[email protected]































Treatment of Individuals With Borderline Personality Disorder Using Dialectical Behavior Therapy in a Community Mental Health Setting: Clinical Application and a Preliminary Investigation D e n i s e D. B e n - P o r a t h , J o h n Carroll University G r e g o r y A. P e t e r s o n a n d J a c q u e l i n e S m e e , C o m m u n i t y Support Services, Akron, O H This article describes an efJbrt to implement and examine dialectical behavior therapy ~ (DBT) effectiveness in a community mental health setting. Modifications made to address unique aspects of community mental health settings are described. Barriers encountered in implementation of DBT treatment in community mental health settings, such as staff turnoveg, maintaining fidelity to the treatment model, staff selection, and structuring skills training, are discussed. Preliminary data are presented that examine the effectiveness of DBT in a group of indigent clients receiving treatment at a community mental health center who have comorbid diagnoses of borderline personality disorder and a s.evere mental illness on Axis L

NDIVIDUALS DIAGNOSED with b o r d e r l i n e personality disorder (BPD) have b e e n described as a m o n g the most challenging populations in the m e n t a l health system (Miller, Eisen, & Allport, 1994). Given the complexity a n d multifaceted n a t u r e of the disorder, traditional treatm e n t modalities have b e e n reported to have limited effectiveness with this population, including individual psychotherapy (Gunderson, Frank, Ronningstam, & Wachter, 1989; McGlashan, 1986; Mohl, Martinez, Ticknor, & Appleby, 1989; Stone, 1990), psychotropic medications (Gardner, & Cowdry, 1985; Soloff, George, & Nathan, 1986), and inpatient hospitalizations (Dawson & MacMillan, 1993; Linehan, 1993; Paris, 2002).

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1077-7229/04/424-43451.00/0 Copyright © 2004 by Association for Advancement of Behavior Therapy. All rights of reproduction in any form reserved.

A psychosocial t r e a t m e n t model, Dialectical Behavior Therapy (DBT) (Linehan, Armstrong, Suarez, Allmon, & Heard, 1991; L i n e h a n , Heard, & Armstrong, 1993) has b e e n developed specifically to treat individuals diagnosed with BPD. This treatment modality has four primary goals: (1) r e d u c i n g life-threatening behaviors (i.e., parasuicidal behaviors a n d suicidal ideation), (2) r e d u c i n g behaviors that interfere with the therapeutic process (i.e., premature termination, missing therapy appointments, etc.), (3) red u c i n g behaviors that interfere with the client's quality of life (i.e., u n e m p l o y m e n t , etc.), a n d (4) increasing behavioral skill use. DBT is one of the few treatments to date that has b e e n shown to be efficacious in a controlled, clinical trial for w o m e n diagnosed with BPD ( L i n e h a n et al., 1991). DBT a n d other empirically supported treatments have b r o u g h t to the forefront the issue of efficacy research. Chambless a n d Hollon (1998), drawing o n the foundations provided