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Behavioral Depression Treatment for African American HIV-infected Substance Users

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Maryland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01351454
First received: May 9, 2011
Last updated: May 10, 2011
Last verified: May 2011

May 9, 2011
May 10, 2011
September 2008
June 2013   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.
  • MEMS [ Time Frame: MEMS is assessed from residential discharge to 12-month follow up period ] [ Designated as safety issue: No ]
    The MEMS cap (AARDEX) is an electronic pill bottle designed to record HIV medication adherence.
  • Urinalysis [ Time Frame: Urinalysis is assessed from residential discharged to a 12-month follow up period ] [ Designated as safety issue: No ]
    Urinalysis is a biological measure of substance use.
  • Time Line Follow Back (TLFB) [ Time Frame: TLFB will be assessed from baseline to a 12-month follow up period ] [ Designated as safety issue: No ]
    The Time Line Follow Back is a self-report measure of drug and alcohol use.
  • 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 ] [ Designated as safety issue: No ]
    The ACTG is self-report measure of HIV medication adherence.
Same as current
Complete list of historical versions of study NCT01351454 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Behavioral Depression Treatment for African American HIV-infected Substance Users
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.

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 170 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Major Depressive Disorder
  • Substance Use
  • Behavioral: 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.
    Other Names:
    • LETS ACT
    • Behavioral Activation
    • Life Steps
  • 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.
    Other Names:
    • Supportive Counseling
    • Life Steps
  • Active Comparator: 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: Behavioral: ACT HEALTHY
  • Placebo Comparator: 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: Behavioral: Nondirective Therapy (NDT)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
June 2013
June 2013   (final data collection date for primary outcome measure)

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]
Both
18 Years to 65 Years
No
Contact: Stacey B. Daughters, Ph.D 301-405-8161 daughter@umd.edu
United States
 
NCT01351454
R01DA022974, R01DA026424
Yes
Stacey B. Daughters, Ph.D, Assistant Professor, Department of Behavioral and Community Health, School of Public Health, University of Maryland, College Park
University of Maryland
National Institute on Drug Abuse (NIDA)
Principal Investigator: Stacey B. Daughters, Ph.D University of Maryland, College Park
University of Maryland
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP