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
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Substance Use
Behavioral: ACT HEALTHY
Behavioral: Nondirective Therapy (NDT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Depression Treatment for African American HIV-infected Substance Users

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 170
Study Start Date: September 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351454

Contacts
Contact: Stacey B. Daughters, Ph.D 301-405-8161 daughter@umd.edu

Locations
United States, District of Columbia
Salvation Army Harbor Light Treatment Center Recruiting
Washington, District of Columbia, United States, 20002
United States, Maryland
University of Maryland Recruiting
College Park, Maryland, United States, 20742
Contact: Stacey B. Daughters, Ph.D    301-405-8161    daughter@umd.edu   
Principal Investigator: Stacey B. Daughters, Ph.D         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Stacey B. Daughters, Ph.D University of Maryland, College Park
  More Information

No publications provided

Responsible Party: Stacey B. Daughters, Ph.D, Assistant Professor, Department of Behavioral and Community Health, School of Public Health, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT01351454     History of Changes
Other Study ID Numbers: R01DA022974, R01DA026424
Study First Received: May 9, 2011
Last Updated: May 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Major Depressive Disorder
Substance Use
HIV Medication Adherence
Behavioral Activation

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014