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Completed

NCT Number: NCT01351454

Behavioral Depression Treatment for African American HIV-infected Substance Users

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salvation Army Harbor Light Treatment Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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]

Treatment and study plan

ACT HEALTHY

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.

Other names: LETS ACT, Behavioral Activation, Life Steps

Nondirective Therapy (NDT)

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.

Other names: Supportive Counseling, Life Steps

Primary outcomes

  1. Beck Depression Inventory (BDI-II; Beck et al., 1996)

    Time frame: BDI-II will be evaluated from baseline to a 12-month follow up period

    The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.

  2. MEMS

    Time frame: MEMS is assessed from residential discharge to 12-month follow up period

    The MEMS cap (AARDEX) is an electronic pill bottle designed to record HIV medication adherence.

  3. Urinalysis

    Time frame: Urinalysis is assessed from residential discharged to a 12-month follow up period

    Urinalysis is a biological measure of substance use.

  4. Time Line Follow Back (TLFB)

    Time frame: TLFB will be assessed from baseline to a 12-month follow up period

    The Time Line Follow Back is a self-report measure of drug and alcohol use.

  5. Adherence to Anti-Retroviral Medications Questionnaire (ACTG; Chesney, Morin, & Sherr, 2000)

    Time frame: ACTG will be assessed from baseline to 12-month follow up period

    The ACTG is self-report measure of HIV medication adherence.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 10, 2011
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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