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

Primary Purpose

Substance Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LETS ACT Behavioral Activation Treatment
Nondirective Therapy (NDT)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Salvation Army Harbor Light Treatment Center
  • University of Maryland

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LETS ACT Behavioral Activation Treatment

Nondirective Therapy (NDT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Substance Use
Urine Screen and Timeline Followback
Beck Depression Inventory (BDI-II; Beck et al., 1996)
The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.

Secondary Outcome Measures

Behavioral Activation for Depression Scale (BADS)
level of activation and avoidance behaviors
Reward Probability Index (RPI)
contact with environmental reward

Full Information

First Posted
August 24, 2010
Last Updated
February 17, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01189552
Brief Title
Depression Treatment for Low Income Substance Users
Acronym
LET'S ACT
Official Title
Depression Treatment for Urban Low Income Minority Substance Users
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LETS ACT Behavioral Activation Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nondirective Therapy (NDT)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LETS ACT Behavioral Activation Treatment
Other Intervention Name(s)
LETS ACT, Behavioral Activation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Nondirective Therapy (NDT)
Other Intervention Name(s)
Supportive Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Substance Use
Description
Urine Screen and Timeline Followback
Time Frame
baseline to a 12-month post treatment follow up period
Title
Beck Depression Inventory (BDI-II; Beck et al., 1996)
Description
The Beck Depression Inventory is a 21-item self-report measure of depressive symptoms.
Time Frame
BDI-II will be evaluated from baseline to a 12-month follow up period
Secondary Outcome Measure Information:
Title
Behavioral Activation for Depression Scale (BADS)
Description
level of activation and avoidance behaviors
Time Frame
baseline to a 12-month post treatment follow up period
Title
Reward Probability Index (RPI)
Description
contact with environmental reward
Time Frame
baseline to a 12-month post treatment follow up period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey B Daughters, Ph.D.
Organizational Affiliation
University of Maryland, College Park
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salvation Army Harbor Light Treatment Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002
Country
United States
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18312046
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.
Results Reference
background
PubMed Identifier
31008636
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.
Results Reference
derived

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Depression Treatment for Low Income Substance Users

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