- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01189552
Depression Treatment for Low Income Substance Users (LET'S ACT)
17 febbraio 2017 aggiornato da: Stacey Daughters, PhD, University of North Carolina, Chapel Hill
Depression Treatment for Urban Low Income Minority Substance Users
The objective of the current study is to evaluate the effects of a brief, behavioral activation treatment (the Life Enhancement Treatment for Substance Use; LET'S ACT) on long term outcomes of substance use, HIV risk behaviors and mechanisms of treatment response (depressive symptoms, environmental reward, behavioral activation).
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Approximately 22% of substance users suffer from elevated depressive symptoms, which is associated with higher rates of substance abuse treatment dropout, relapse to substance use, and HIV risk behavior.
Few interventions targeting reinforcement principles have been developed to meet the specific needs of treatment seeking substance users.
One approach that may be especially appropriate in this regard is behavioral activation (BA), which aims to increase individuals' engagement in pleasant events, thereby increasing contact with positive reinforcement and decreasing the frequency of aversive events.
BA has been shown to be efficacious in the treatment of depression, and this uncomplicated and straightforward approach may be especially appropriate for the specific needs of an inner city low income substance abusing sample.
Further, BA compliments standard substance abuse treatment in several key practical and theoretical ways as it is more easily adopted by staff in these settings, more time efficient (e.g., fewer and shorter sessions, group format), more easily understood by patients who suffer from cognitive limitations due to low education level and chronic drug use, and can incorporate aspects of sobriety into its treatment components.
In an initial Stage 1 development project, a version of BA, the Life Enhancement Treatment for Substance Use (LETS ACT), was developed and specifically tailored for inner-city low income minority substance users with elevated depressive symptoms.
Results demonstrated that LETS ACT led to a significantly greater reduction in self-reported depressive symptoms and a significant increase in enjoyment and reward value of activities as compared to the TAU control group (Daughters et al., 2008).
While preliminary findings prove promising, many questions remain unanswered and several extensions of this work are necessary, including an assessment of post treatment substance use and HIV risk behavior, a contact-matched control, and a larger sample size to allow for more complex analyses of the mechanisms underlying these outcomes.
Thus, the objective of the present proposal is to follow-up on our previous Stage 1 treatment development efforts and small scale randomized control trial (RCT) with a fully-powered Stage 2 RCT comparing LETS ACT to nondirective therapy (NDT) among a sample of 263 low income depressed substance users currently receiving residential substance abuse treatment in inner-city Washington, DC.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
263
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20002
- Salvation Army Harbor Light Treatment Center
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Maryland
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College Park, Maryland, Stati Uniti, 20742
- University of Maryland
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- between 18 and 65 years of age
- beginning their last month of residential treatment
Exclusion Criteria:
- limited mental competency [Mini Mental State Examination score < 23]
- psychosis
- the use of psychotropic medication for < 3 months
- the inability to give informed, voluntary, written consent to participate
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: LETS ACT Behavioral Activation Treatment
LETS ACT is based on the empirically validated Behavioral Activation Treatment for Depression (BAT-D; Lejuez, Hopko, & Hopko, 2001).
LETS ACT is based on the belief that the best way to improve mood, remain sober, and to make long-term life changes is by changing and increasing one's activity level.
It has been modified to accommodate the needs of a substance using population currently receiving inpatient substance use treatment.
Treatment is provided over a 4-week period and is provided in small group format, with each group consisting of 3-5 patients.
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LETS ACT is based on the empirically validated Behavioral Activation Treatment for Depression (BAT-D; Lejuez, Hopko, & Hopko, 2001).
Treatment includes eight sessions over a four-week period and is provided in small group format, with each group consisting of 3-5 patients.
Altri nomi:
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Comparatore placebo: 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.
Treatment is provided over a 4-week period and is provided in small group format, with each group consisting of 3-5 patients.
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The purpose of Nondirective Therapy (NDT) is to provide group therapy interaction, allowing for the development of a close therapeutic relationship and a safe and accepting environment to facilitate change.
NDT will be conducted as outlined by Crits-Cristoph (1997).
That is, 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.
Patients will received NDT in a small group format (3-5 participants) and will meet over the course of 4 weeks.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Substance Use
Lasso di tempo: baseline to a 12-month post treatment follow up period
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Urine Screen and Timeline Followback
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baseline to a 12-month post treatment follow up period
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Beck Depression Inventory (BDI-II; Beck et al., 1996)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Behavioral Activation for Depression Scale (BADS)
Lasso di tempo: baseline to a 12-month post treatment follow up period
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level of activation and avoidance behaviors
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baseline to a 12-month post treatment follow up period
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Reward Probability Index (RPI)
Lasso di tempo: baseline to a 12-month post treatment follow up period
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contact with environmental reward
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baseline to a 12-month post treatment follow up period
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Stacey B Daughters, Ph.D., University of Maryland, College Park
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Daughters SB, Braun AR, Sargeant MN, Reynolds EK, Hopko DR, Blanco C, Lejuez CW. Effectiveness of a brief behavioral treatment for inner-city illicit drug users with elevated depressive symptoms: the life enhancement treatment for substance use (LETS Act!). J Clin Psychiatry. 2008 Jan;69(1):122-9. doi: 10.4088/jcp.v69n0116.
- Reese ED, Conway CC, Anand D, Bauer DJ, Daughters SB. Distress tolerance trajectories following substance use treatment. J Consult Clin Psychol. 2019 Jul;87(7):645-656. doi: 10.1037/ccp0000403. Epub 2019 Apr 22.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 ottobre 2010
Completamento primario (Effettivo)
1 giugno 2015
Completamento dello studio (Effettivo)
1 giugno 2015
Date di iscrizione allo studio
Primo inviato
24 agosto 2010
Primo inviato che soddisfa i criteri di controllo qualità
25 agosto 2010
Primo Inserito (Stima)
26 agosto 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 febbraio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 febbraio 2017
Ultimo verificato
1 febbraio 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R01DA026424 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su LETS ACT Behavioral Activation Treatment
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University of WashingtonCompletatoSchizofrenia | Disordine bipolare | Grave malattia mentale
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University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA)CompletatoSintomi comportamentali | Disturbi Correlati a Sostanze | Disordine depressivo | Comportamento sessuale | L'assunzione di rischiStati Uniti
-
University of North Carolina, Chapel HillWuhan Center for Disease Control and PreventionCompletatoDisturbi Correlati a Sostanze | Disordini mentali | Disturbi dell'umore | Trattamento di attivazione comportamentaleCina