Depression Treatment for Low Income Substance Users

Substance Use Disorder Clinical Trial

— LET'S ACT  

Official title:

Depression Treatment for Urban Low Income Minority Substance Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189552
• Other study ID #: R01DA026424
• Secondary ID: R01DA026424
• Status: Completed
• Phase: N/A
• First received: August 24, 2010
• Last updated: February 17, 2017
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: February 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Substance Use Disorder
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Maryland	College Park	Maryland
United States	Salvation Army Harbor Light Treatment Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Substance Use	Urine Screen and Timeline Followback	baseline to a 12-month post treatment follow up period
Primary	Beck Depression Inventory (BDI-II; Beck et al., 1996)	The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.	BDI-II will be evaluated from baseline to a 12-month follow up period
Secondary	Behavioral Activation for Depression Scale (BADS)	level of activation and avoidance behaviors	baseline to a 12-month post treatment follow up period
Secondary	Reward Probability Index (RPI)	contact with environmental reward	baseline to a 12-month post treatment follow up period