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Depression Treatment for Low Income Substance Users (LET'S ACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01189552
Recruitment Status : Completed
First Posted : August 26, 2010
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Stacey Daughters, PhD, University of North Carolina, Chapel Hill

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Substance Use Disorder Behavioral: LETS ACT Behavioral Activation Treatment Behavioral: Nondirective Therapy (NDT) Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Depression Treatment for Urban Low Income Minority Substance Users
Actual Study Start Date : October 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: LETS ACT Behavioral Activation Treatment
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.
Other Names:
  • LETS ACT
  • Behavioral Activation

Placebo Comparator: 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.
Behavioral: Nondirective Therapy (NDT)
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.
Other Name: Supportive Counseling




Primary Outcome Measures :
  1. Substance Use [ Time Frame: baseline to a 12-month post treatment follow up period ]
    Urine Screen and Timeline Followback

  2. 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.


Secondary Outcome Measures :
  1. Behavioral Activation for Depression Scale (BADS) [ Time Frame: baseline to a 12-month post treatment follow up period ]
    level of activation and avoidance behaviors

  2. Reward Probability Index (RPI) [ Time Frame: baseline to a 12-month post treatment follow up period ]
    contact with environmental reward



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189552


Locations
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United States, District of Columbia
Salvation Army Harbor Light Treatment Center
Washington, District of Columbia, United States, 20002
United States, Maryland
University of Maryland
College Park, Maryland, United States, 20742
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Stacey B Daughters, Ph.D. University of Maryland, College Park

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stacey Daughters, PhD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01189552    
Other Study ID Numbers: R01DA026424 ( U.S. NIH Grant/Contract )
R01DA026424 ( U.S. NIH Grant/Contract )
First Posted: August 26, 2010    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Substance-Related Disorders
Depression
Behavioral Symptoms
Chemically-Induced Disorders
Mental Disorders