Behavioral Depression Treatment for African American HIV-infected Substance Users
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ClinicalTrials.gov Identifier: NCT01351454 |
Recruitment Status
:
Completed
First Posted
: May 10, 2011
Last Update Posted
: April 12, 2017
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Condition or disease | Intervention/treatment | Phase |
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Depression Substance Use | Behavioral: ACT HEALTHY Behavioral: Nondirective Therapy (NDT) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 122 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Behavioral Depression Treatment for African American HIV-infected Substance Users |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
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.
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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:
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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.
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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:
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- 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.
- 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.
- Urinalysis [ Time Frame: Urinalysis is assessed from residential discharged to a 12-month follow up period ]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 ]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 ]The ACTG is self-report measure of HIV medication adherence.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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]

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351454
United States, District of Columbia | |
Salvation Army Harbor Light Treatment Center | |
Washington, District of Columbia, United States, 20002 | |
United States, Maryland | |
University of Maryland | |
College Park, Maryland, United States, 20742 |
Principal Investigator: | Stacey B. Daughters, Ph.D | University of Maryland, College Park |
Publications:
Responsible Party: | University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT01351454 History of Changes |
Other Study ID Numbers: |
06-0341 R01DA026424 ( U.S. NIH Grant/Contract ) R01DA022974 ( U.S. NIH Grant/Contract ) |
First Posted: | May 10, 2011 Key Record Dates |
Last Update Posted: | April 12, 2017 |
Last Verified: | May 2011 |
Keywords provided by University of North Carolina, Chapel Hill:
Depression Substance Use HIV Medication Adherence Behavioral Activation |
Additional relevant MeSH terms:
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |