Clinical trial NCT01189552: Depression Treatment for Low Income Substance Users
Official title: Depression Treatment for Urban Low Income Minority Substance Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-08-26
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Substance Use
timeFrame: baseline to a 12-month post treatment follow up period
measure: Beck Depression Inventory (BDI-II; Beck et al., 1996)
timeFrame: BDI-II will be evaluated from baseline to a 12-month follow up period
Secondary outcomes:
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: baseline to a 12-month post treatment follow up period
measure: Reward Probability Index (RPI)
timeFrame: baseline to a 12-month post treatment follow up period
Other outcomes:
Locations:
city: Washington
country: United States
facility: Salvation Army Harbor Light Treatment Center
state: District of Columbia
city: College Park
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Stacey B Daughters, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.