NCT01189552

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

4.7 years

First QC Date

August 24, 2010

Last Update Submit

February 17, 2017

Conditions

Substance Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Substance Use

    Urine Screen and Timeline Followback

    baseline to a 12-month post treatment follow up period

  • 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 Outcomes (2)

  • Behavioral Activation for Depression Scale (BADS)

    baseline to a 12-month post treatment follow up period

  • Reward Probability Index (RPI)

    baseline to a 12-month post treatment follow up period

Study Arms (2)

LETS ACT Behavioral Activation Treatment

ACTIVE COMPARATOR

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

Nondirective Therapy (NDT)

PLACEBO COMPARATOR

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)

Interventions

LETS ACT Behavioral Activation TreatmentBEHAVIORAL

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.

Also known as: LETS ACT, Behavioral Activation
LETS ACT Behavioral Activation Treatment
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.

Also known as: Supportive Counseling
Nondirective Therapy (NDT)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between 18 and 65 years of age
  • beginning their last month of residential treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Salvation Army Harbor Light Treatment Center

Washington D.C., District of Columbia, 20002, United States

Location

University of Maryland

College Park, Maryland, 20742, United States

Location

Related Publications (3)

  • 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.

    PMID: 18312046BACKGROUND

  • Kane L, Benson K, Stewart ZJ, Daughters SB. The impact of spiritual well-being and social support on substance use treatment outcomes within a sample of predominantly Black/African American adults. J Subst Use Addict Treat. 2024 Mar;158:209238. doi: 10.1016/j.josat.2023.209238. Epub 2023 Dec 5.

    PMID: 38061630DERIVED

  • 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.

    PMID: 31008636DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Person-Centered Psychotherapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Stacey B Daughters, Ph.D.

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 26, 2010

Study Start

October 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(2)