DepressionNCT01351454
Behavioral Depression Treatment for African American HIV-infected Substance Users
A study testing ACT HEALTHY and Nondirective Therapy (NDT) in people with Depression and Substance Use, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression, Substance Use
- What is being tested?
- ACT HEALTHY and Nondirective Therapy (NDT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2008to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 and 65 years of age
- HIV positive
Who cannot join
- psychosis
- the inability to give informed, voluntary, written consent to participate
- reading ability [below 3rd grade level on the WRAT]
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland
College Park, Maryland, 20742
Salvation Army Harbor Light Treatment Center
Washington D.C., District of Columbia, 20002
About this study
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.
Read the 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.
- Conditions
- Depression, Substance Use
- Being tested
- ACT HEALTHY, Nondirective Therapy (NDT)
- Keywords
- Depression, Substance Use, HIV Medication Adherence, Behavioral Activation
- Medical subject headings
- Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT HEALTHYBehavioural
Also called LETS ACT, Behavioral Activation, Life Steps
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.
Nondirective Therapy (NDT)Behavioural
Also called Supportive Counseling, Life Steps
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.
| Study group | Role | What they receive |
|---|---|---|
| ACT HEALTHY | Active comparator | 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. Receives: Behavioral: ACT HEALTHY |
| Nondirective Therapy (NDT) | Placebo comparator | 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. Receives: Behavioral: Nondirective Therapy (NDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI-II; Beck et al., 1996)
The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.
Measured: BDI-II will be evaluated from baseline to a 12-month follow up period
MEMS
The MEMS cap (AARDEX) is an electronic pill bottle designed to record HIV medication adherence.
Measured: MEMS is assessed from residential discharge to 12-month follow up period
Urinalysis
Urinalysis is a biological measure of substance use.
Measured: Urinalysis is assessed from residential discharged to a 12-month follow up period
Time Line Follow Back (TLFB)
The Time Line Follow Back is a self-report measure of drug and alcohol use.
Measured: TLFB will be assessed from baseline to a 12-month follow up period
Adherence to Anti-Retroviral Medications Questionnaire (ACTG; Chesney, Morin, & Sherr, 2000)
The ACTG is self-report measure of HIV medication adherence.
Measured: ACTG will be assessed from baseline to 12-month follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startSep 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Stacey B. Daughters, Ph.D, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351454
- Sponsor's protocol ID
- 06-0341
- Other IDs
- R01DA026424, R01DA022974
- Status last verified
- Sep 2020
- First submitted
- 9 May 2011
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21709737Belus JM, Tralka H, Satinsky EN, Seitz-Brown CJ, Daughters SB, Magidson JF. Substance Use Outcomes Among Sexual and Gender Minority Individuals Living with HIV Following Residential Substance Use Treatment in Washington, DC. Alcohol Treat Q. 2023;41(4):373-385. doi: 10.1080/07347324.2023.2241419. Epub 2023 Aug 8.
PubMed 37886040Magidson 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.
PubMed 34173895
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Depression Treatment for African American HIV-infected Substance Users
- ClinicalTrials.gov ID
- NCT01351454
- Acronym / sponsor ID
- 06-0341
- Conditions
- Depression, Substance Use
- Keywords
- Depression, Substance Use, HIV Medication Adherence, Behavioral Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT HEALTHY | Active comparator | Behavioral: ACT HEALTHYACT 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. |
| Nondirective Therapy (NDT) | Placebo comparator | 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between 18 and 65 years of age
- HIV positive
Key exclusion criteria (3 listed)
- psychosis
- the inability to give informed, voluntary, written consent to participate
- reading ability [below 3rd grade level on the WRAT]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT HEALTHYAlso: LETS ACT, Behavioral Activation, Life StepsACT 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. | Behavioural | ACT HEALTHY |
| Nondirective Therapy (NDT)Also: Supportive Counseling, Life StepsIn 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. | Behavioural | Nondirective Therapy (NDT) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Background: PubMed 21709737Daughters 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.
- Derived from this study: PubMed 37886040Belus JM, Tralka H, Satinsky EN, Seitz-Brown CJ, Daughters SB, Magidson JF. Substance Use Outcomes Among Sexual and Gender Minority Individuals Living with HIV Following Residential Substance Use Treatment in Washington, DC. Alcohol Treat Q. 2023;41(4):373-385. doi: 10.1080/07347324.2023.2241419. Epub 2023 Aug 8.
- Derived from this study: PubMed 34173895Magidson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey B. Daughters, Ph.D principal investigator
University of Maryland, College Park
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT HEALTHY and Nondirective Therapy (NDT) in people with Depression and Substance Use, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351454, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.