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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

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:
  • LETS ACT
  • Beteendeaktivering
  • Life Steps
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:
  • Supportive Counseling
  • Life Steps

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.

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.

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

Andra studie-ID-nummer

  • 06-0341
  • R01DA026424 (U.S.S. NIH-anslag/kontrakt)
  • R01DA022974 (U.S.S. NIH-anslag/kontrakt)

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Kliniska prövningar på Depression

Kliniska prövningar på ACT HEALTHY

3
Prenumerera