Behavioral Depression Treatment for African American HIV-infected Substance Users

NCT ID: NCT01351454

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2013-06-30

Brief Summary

The objective of the current study is to test a novel, behavioral approach to treat depressive symptoms and improve HIV medication adherence and subsequent physical health outcomes among African American HIV-infected substance users residing in inner-city Washington, DC. This treatment will serve as a compliment to standard residential and follow-up outpatient substance use treatment, with the goal of reducing depressive symptoms and improving HIV medication adherence, physical health, and substance use outcomes.

Detailed Description

Approximately 37-50% of HIV positive individuals suffer from depression, which is associated with substance use, poor adherence to HIV medication, an increase in HIV risk behaviors, and subsequent poor health outcomes (e.g., Asch et al., 2003; Bing et al., 2001; Dew et al., 1997; Johnson, Rabkin, Lipsitz, Williams, & Remien, 1999). Additionally, depressed HIV positive substance users are at an even greater risk for poor medication adherence than non-substance users (Cook, Grey, & Burke-Miller, 2004). Notably, evidence indicates that HIV positive patients who receive treatment for depression exhibit significant improvements in HIV medication adherence and a reduction in risk behaviors that are directly relevant to their health and well being such as risky sexual behavior (e.g., Cook et al., 2006). Despite this link, few interventions targeting depression have been developed to meet the specific needs of HIV-infected substance users. This is especially evident for low income African American HIV positive substance users who often do not receive adequate treatment for any of these conditions due to poverty, lack of access to specialized treatment, low motivation, cognitive impairments, and a lack of coordination between medical, mental health, and substance abuse treatment providers (Calsyn et al., 2004). Thus, the objective of the present proposal is to test a novel, behavioral approach to treat depressive symptoms and improve HIV medication adherence and subsequent physical health outcomes among African American HIV infected substance users residing in inner-city Washington, DC. This treatment combines (1) LET'S ACT, a behavioral activation based treatment for depressed substance users (Daughters, Braun, Sargeant, Hopko, Blanco, & Lejuez, 2008), with (2) Life Steps, an HIV medication adherence intervention (Safren, Otto, & Worth, 1999). The purpose of this combined treatment will be to compliment standard residential and follow-up outpatient substance use treatment to specifically treat depressive symptoms with the additional goal of improving HIV medication adherence, substance use, and physical health outcomes. Participants will be randomly assigned to either treatment as usual (TAU) plus ACT HEALTHY or TAU plus Nondirective Therapy to test the efficacy of ACT HEALTHY. Treatment as usual for both groups consists of standard residential and outpatient substance abuse treatment. Based on the outcome of this preliminary trial, the ACT HEALTHY protocol will be further refined and readied for larger-scale clinical trials.

Conditions

Depression; Substance Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ACT HEALTHY

ACT HEALTHY is based on the empirically validated Behavioral Activation Treatment for Depression (BAT-D; Lejuez, Hopko, \& Hopko, 2001) and Life Steps, an HIV medication adherence intervention (Safren, Otto, \& Worth, 1999). ACT HEALTHY is based on the belief that the best way to improve mood, remain sober, increase medication adherence, and make long-term life changes is by changing and increasing one's activity level. Treatment includes 16 individual sessions over a 12-week period.

Group Type: ACTIVE_COMPARATOR

ACT HEALTHY

Intervention Type: BEHAVIORAL

ACT HEALTHY is based on the empirically validated Behavioral Activation Treatment for Depression (BAT-D; Lejuez, Hopko, \& Hopko, 2001) and Life Steps, an HIV medication adherence intervention (Safren, Otto, \& Worth, 1999). ACT HEALTHY is based on the belief that the best way to improve mood, remain sober, increase medication adherence, and make long-term life changes is by changing and increasing one's activity level. Treatment includes 16 individual sessions over a 12-week period.

Nondirective Therapy (NDT)

In NDT, the therapist will create an accepting, nonjudgmental, empathic environment to continuously direct client attention to primary feelings, and to facilitate accepting of affective experience using supportive statements, reflective listening, and empathic communications. In addition, medication adherence is addressed with the Life Steps HIV medication adherence intervention (Safren, Otto, \& Worth, 1999). Treatment includes 16 individual sessions over a 12-week period.

Group Type: PLACEBO_COMPARATOR

Nondirective Therapy (NDT)

Intervention Type: BEHAVIORAL

In NDT, the therapist will create an accepting, nonjudgmental, empathic environment to continuously direct client attention to primary feelings, and to facilitate accepting of affective experience using supportive statements, reflective listening, and empathic communications. In addition, medication adherence is addressed with the Life Steps HIV medication adherence intervention (Safren, Otto, \& Worth, 1999). Treatment includes 16 individual sessions over a 12-week period.

Interventions

ACT HEALTHY

ACT HEALTHY is based on the empirically validated Behavioral Activation Treatment for Depression (BAT-D; Lejuez, Hopko, \& Hopko, 2001) and Life Steps, an HIV medication adherence intervention (Safren, Otto, \& Worth, 1999). ACT HEALTHY is based on the belief that the best way to improve mood, remain sober, increase medication adherence, and make long-term life changes is by changing and increasing one's activity level. Treatment includes 16 individual sessions over a 12-week period.

Intervention Type: BEHAVIORAL

Nondirective Therapy (NDT)

In NDT, the therapist will create an accepting, nonjudgmental, empathic environment to continuously direct client attention to primary feelings, and to facilitate accepting of affective experience using supportive statements, reflective listening, and empathic communications. In addition, medication adherence is addressed with the Life Steps HIV medication adherence intervention (Safren, Otto, \& Worth, 1999). Treatment includes 16 individual sessions over a 12-week period.

Intervention Type: BEHAVIORAL

Other Intervention Names

LETS ACT; Behavioral Activation; Life Steps; Supportive Counseling; Life Steps

Eligibility Criteria

Inclusion Criteria

• between 18 and 65 years of age
• HIV positive

Exclusion Criteria

• psychosis
• the inability to give informed, voluntary, written consent to participate
• reading ability [below 3rd grade level on the WRAT]

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacey B. Daughters, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Locations

Salvation Army Harbor Light Treatment Center

Washington D.C., District of Columbia, United States

University of Maryland

College Park, Maryland, United States

Countries

United States

References

Daughters SB, Magidson JF, Schuster RM, Safren SA. ACT HEALTHY: A Combined Cognitive-Behavioral Depression and Medication Adherence Treatment for HIV-Infected Substance Users. Cogn Behav Pract. 2010 Aug 1;17(3):309-321. doi: 10.1016/j.cbpra.2009.12.003.

Reference Type: BACKGROUND

PMID: 21709737 (View on PubMed)

Belus JM, Tralka H, Satinsky EN, Seitz-Brown CJ, Daughters SB, Magidson JF. Substance Use Outcomes Among Sexual and Gender Minority Individuals Living with HIV Following Residential Substance Use Treatment in Washington, DC. Alcohol Treat Q. 2023;41(4):373-385. doi: 10.1080/07347324.2023.2241419. Epub 2023 Aug 8.

Reference Type: DERIVED

PMID: 37886040 (View on PubMed)

Magidson JF, Belus JM, Seitz-Brown CJ, Tralka H, Safren SA, Daughters SB. Act Healthy: A Randomized Clinical Trial Evaluating a Behavioral Activation Intervention to Address Substance Use and Medication Adherence Among Low-Income, Black/African American Individuals Living with HIV/AIDS. AIDS Behav. 2022 Jan;26(1):102-115. doi: 10.1007/s10461-021-03354-1. Epub 2021 Jun 26.

Reference Type: DERIVED

PMID: 34173895 (View on PubMed)

Other Identifiers

R01DA026424

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01DA022974

Identifier Type: NIH

Identifier Source: secondary_id

View Link

06-0341

Identifier Type: -

Identifier Source: org_study_id