search
Back to results

Behavioral Depression Treatment for African American HIV-infected Substance Users

Primary Purpose

Depression, Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACT HEALTHY
Nondirective Therapy (NDT)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Substance Use, HIV Medication Adherence, Behavioral Activation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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]

Sites / Locations

  • Salvation Army Harbor Light Treatment Center
  • University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ACT HEALTHY

Nondirective Therapy (NDT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Beck Depression Inventory (BDI-II; Beck et al., 1996)
The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.
MEMS
The MEMS cap (AARDEX) is an electronic pill bottle designed to record HIV medication adherence.
Urinalysis
Urinalysis is a biological measure of substance use.
Time Line Follow Back (TLFB)
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)
The ACTG is self-report measure of HIV medication adherence.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2011
Last Updated
September 3, 2020
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT01351454
Brief Title
Behavioral Depression Treatment for African American HIV-infected Substance Users
Official Title
Behavioral Depression Treatment for African American HIV-infected Substance Users
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Substance Use
Keywords
Depression, Substance Use, HIV Medication Adherence, Behavioral Activation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACT HEALTHY
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nondirective Therapy (NDT)
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
ACT HEALTHY
Other Intervention Name(s)
LETS ACT, Behavioral Activation, Life Steps
Intervention Description
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
Intervention Name(s)
Nondirective Therapy (NDT)
Other Intervention Name(s)
Supportive Counseling, Life Steps
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Depression Inventory (BDI-II; Beck et al., 1996)
Description
The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.
Time Frame
BDI-II will be evaluated from baseline to a 12-month follow up period
Title
MEMS
Description
The MEMS cap (AARDEX) is an electronic pill bottle designed to record HIV medication adherence.
Time Frame
MEMS is assessed from residential discharge to 12-month follow up period
Title
Urinalysis
Description
Urinalysis is a biological measure of substance use.
Time Frame
Urinalysis is assessed from residential discharged to a 12-month follow up period
Title
Time Line Follow Back (TLFB)
Description
The Time Line Follow Back is a self-report measure of drug and alcohol use.
Time Frame
TLFB will be assessed from baseline to a 12-month follow up period
Title
Adherence to Anti-Retroviral Medications Questionnaire (ACTG; Chesney, Morin, & Sherr, 2000)
Description
The ACTG is self-report measure of HIV medication adherence.
Time Frame
ACTG will be assessed from baseline to 12-month follow up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey B. Daughters, Ph.D
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salvation Army Harbor Light Treatment Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002
Country
United States
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21709737
Citation
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.
Results Reference
background
PubMed Identifier
34173895
Citation
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.
Results Reference
derived

Learn more about this trial

Behavioral Depression Treatment for African American HIV-infected Substance Users

We'll reach out to this number within 24 hrs