- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01351454
Behavioral Depression Treatment for African American HIV-infected Substance Users
3. September 2020 aktualisiert von: University of North Carolina, Chapel Hill
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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
61
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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District of Columbia
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Washington, District of Columbia, Vereinigte Staaten, 20002
- Salvation Army Harbor Light Treatment Center
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Maryland
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College Park, Maryland, Vereinigte Staaten, 20742
- University of Maryland
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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]
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 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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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.
Andere Namen:
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Placebo-Komparator: 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.
|
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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Beck Depression Inventory (BDI-II; Beck et al., 1996)
Zeitfenster: BDI-II will be evaluated from baseline to a 12-month follow up period
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The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.
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BDI-II will be evaluated from baseline to a 12-month follow up period
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MEMS
Zeitfenster: MEMS is assessed from residential discharge to 12-month follow up period
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The MEMS cap (AARDEX) is an electronic pill bottle designed to record HIV medication adherence.
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MEMS is assessed from residential discharge to 12-month follow up period
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Urinalysis
Zeitfenster: Urinalysis is assessed from residential discharged to a 12-month follow up period
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Urinalysis is a biological measure of substance use.
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Urinalysis is assessed from residential discharged to a 12-month follow up period
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Time Line Follow Back (TLFB)
Zeitfenster: TLFB will be assessed from baseline to a 12-month follow up period
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The Time Line Follow Back is a self-report measure of drug and alcohol use.
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TLFB will be assessed from baseline to a 12-month follow up period
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Adherence to Anti-Retroviral Medications Questionnaire (ACTG; Chesney, Morin, & Sherr, 2000)
Zeitfenster: ACTG will be assessed from baseline to 12-month follow up period
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The ACTG is self-report measure of HIV medication adherence.
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ACTG will be assessed from baseline to 12-month follow up period
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Stacey B. Daughters, Ph.D, University of Maryland, College Park
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. September 2008
Primärer Abschluss (Tatsächlich)
1. Juni 2013
Studienabschluss (Tatsächlich)
1. Juni 2013
Studienanmeldedaten
Zuerst eingereicht
9. Mai 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Mai 2011
Zuerst gepostet (Schätzen)
10. Mai 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
7. September 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
3. September 2020
Zuletzt verifiziert
1. September 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 06-0341
- R01DA026424 (US NIH Stipendium/Vertrag)
- R01DA022974 (US NIH Stipendium/Vertrag)
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