LET'S ACT: Depression Treatment for Low Income Substance Users

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT01189552
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
263
2
2
56
131.5
2.3

Study Details

Study Description

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
  • Behavioral: LETS ACT Behavioral Activation Treatment
  • Behavioral: Nondirective Therapy (NDT)
N/A

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.

Study Design

Study Type:
Interventional
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 :
Oct 1, 2010
Actual Primary Completion Date :
Jun 1, 2015
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

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 Names:
  • Supportive Counseling
  • Outcome Measures

    Primary Outcome Measures

    1. Substance Use [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) [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) [baseline to a 12-month post treatment follow up period]

      level of activation and avoidance behaviors

    2. Reward Probability Index (RPI) [baseline to a 12-month post treatment follow up period]

      contact with environmental reward

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Salvation Army Harbor Light Treatment Center Washington District of Columbia United States 20002
    2 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

    • Principal Investigator: Stacey B Daughters, Ph.D., University of Maryland, College Park

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Stacey Daughters, PhD, Associate Professor, University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT01189552
    Other Study ID Numbers:
    • R01DA026424
    • R01DA026424
    First Posted:
    Aug 26, 2010
    Last Update Posted:
    Feb 23, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 23, 2017