- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01351454
Behavioral Depression Treatment for African American HIV-infected Substance Users
3 september 2020 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
61
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
District of Columbia
-
Washington, District of Columbia, Förenta staterna, 20002
- Salvation Army Harbor Light Treatment Center
-
-
Maryland
-
College Park, Maryland, Förenta staterna, 20742
- University of Maryland
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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]
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv 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.
|
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.
Andra namn:
|
Placebo-jämförare: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Beck Depression Inventory (BDI-II; Beck et al., 1996)
Tidsram: 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.
|
BDI-II will be evaluated from baseline to a 12-month follow up period
|
MEMS
Tidsram: 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.
|
MEMS is assessed from residential discharge to 12-month follow up period
|
Urinalysis
Tidsram: Urinalysis is assessed from residential discharged to a 12-month follow up period
|
Urinalysis is a biological measure of substance use.
|
Urinalysis is assessed from residential discharged to a 12-month follow up period
|
Time Line Follow Back (TLFB)
Tidsram: 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.
|
TLFB will be assessed from baseline to a 12-month follow up period
|
Adherence to Anti-Retroviral Medications Questionnaire (ACTG; Chesney, Morin, & Sherr, 2000)
Tidsram: ACTG will be assessed from baseline to 12-month follow up period
|
The ACTG is self-report measure of HIV medication adherence.
|
ACTG will be assessed from baseline to 12-month follow up period
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Stacey B. Daughters, Ph.D, University of Maryland, College Park
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2008
Primärt slutförande (Faktisk)
1 juni 2013
Avslutad studie (Faktisk)
1 juni 2013
Studieregistreringsdatum
Först inskickad
9 maj 2011
Först inskickad som uppfyllde QC-kriterierna
9 maj 2011
Första postat (Uppskatta)
10 maj 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 september 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 september 2020
Senast verifierad
1 september 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 06-0341
- R01DA026424 (U.S.S. NIH-anslag/kontrakt)
- R01DA022974 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Depression
-
ProgenaBiomeRekryteringDepression | Depression, postpartum | Depression, ångest | Depression Måttlig | Depression Svår | Klinisk depression | Depression i remission | Depression, Endogen | Depression KroniskFörenta staterna
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRekryteringDepression | Depression Måttlig | Depression Svår | Depression MildFörenta staterna
-
University of California, San FranciscoRekryteringDepression Måttlig | Depression Mild | Depression, tonåringFörenta staterna
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.Rekrytering
-
Washington University School of MedicineAvslutadBehandling Resistent depression | Senlivsdepression | Geriatrisk depression | Refraktär depression | Terapiresistent depressionFörenta staterna, Kanada
-
Baylor College of MedicineUniversity of TexasRekryteringDepression | Depression Måttlig | Depression Svår | Självmord och självskada | Depression i tonåren | Depression MildFörenta staterna
-
University of Cape TownNational Institute of Mental Health (NIMH)AvslutadPostpartum depression | Klinisk depression | Måttlig depressionSydafrika
-
Gerbera Therapeutics, Inc.Har inte rekryterat ännuPostpartum depression | Depression, postpartum | Postnatal depression | Post-partum depression | Post-Natal depressionFörenta staterna
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoAvslutadDepression Måttlig | Depression MildFörenta staterna, Dominikanska republiken
-
Charite University, Berlin, GermanyAvslutadBehandling Resistent depression | Depression, unipolär | Depression KroniskTyskland
Kliniska prövningar på ACT HEALTHY
-
Rush University Medical CenterAvslutadDepression | ÅngestFörenta staterna
-
Johns Hopkins Bloomberg School of Public HealthEunice Kennedy Shriver National Institute of Child Health and Human Development... och andra samarbetspartnersAvslutad
-
Baylor College of MedicineAvslutadFetmaFörenta staterna
-
Human Development Research Foundation, PakistanUniversity of Liverpool; Shifa Tameer-e-Millat UniversityAktiv, inte rekryterandeDepression, postpartum | Perinatal depressionPakistan
-
Oklahoma State University Center for Health SciencesUniversity of Oklahoma; Osage NationAktiv, inte rekryterandeBlodtryck | Mat osäkerhet | Övervikt eller fetma | Diet, hälsosam | HälsostatusFörenta staterna
-
University Hospital, Gentofte, CopenhagenTrygFonden, DenmarkAvslutad
-
The University of Texas at ArlingtonUniversity of South Florida; Center for Transportation, Equity, Decisions...AvslutadBrist på resurser | Brist på rörlighetFörenta staterna
-
University of California, San FranciscoNational Institute of Mental Health (NIMH)AvslutadDepression | Ångest | Kronisk sjukdomIndien
-
Idorsia Pharmaceuticals Ltd.AvslutadFriska ämnenNederländerna
-
University of Wisconsin, MadisonAvslutadPsykisk ohälsa | Ensamhet | Depression, ångestFörenta staterna