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Completed

NCT Number: NCT01189552

Depression Treatment for Low Income 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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salvation Army Harbor Light Treatment Center, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LETS ACT Behavioral Activation Treatment

Behavioral

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

Nondirective Therapy (NDT)

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Depression Treatment for Urban Low Income Minority Substance Users

Acronym: LET'S ACT

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2010
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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