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Clinical Trials/NCT03678051
NCT03678051
Completed
Not Applicable

A Randomized Trial of CBT4CBT for Women in Residential Treatment for Substance Use Disorders

Virginia Commonwealth University1 site in 1 country63 target enrollmentOctober 4, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
Virginia Commonwealth University
Enrollment
63
Locations
1
Primary Endpoint
Days of Use
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This project examines computer-delivered cognitive-behavioral intervention (CBT4CBT) as an adjunct to residential treatment for women with substance use disorders (SUD). The project will conduct a 2-arm randomized clinical trial (RCT) comparing post-discharge relapse rates for treatment as usual (TAU) with access to the CBT4CBT program vs. TAU in a residential sample of women with SUDs.

Detailed Description

Women with substance use disorders face unique barriers to substance use treatment, and as a result, are less likely to seek treatment for substance use than their male counterparts. Women's residential treatment settings have been shown to have higher rates of treatment completion and better outcomes; however, relapse rates for substance use are high, with estimates ranging from 40-60%. Cognitive behavioral therapy (CBT) has been identified as an evidence-based treatment known to improve relapse rates by teaching clients how to recognize and respond to their cues for substance use. Women may particularly benefit from CBT, as their relapse risk factors include depression, interpersonal stress, and relationship conflict. Despite the effectiveness of CBT, its dissemination is hindered due to limited availability of trained clinicians, cost, and limited resources. Computer-based training for cognitive behavioral therapy (CBT4CBT) offers an opportunity to improve the quality and reach of treatment services that is both feasible and cost-effective. Studies to date have demonstrated the utility of CBT4CBT in outpatient settings; however, it has not yet been evaluated as an adjunct to residential treatment for SUDs. The specific aims are to: 1) Examine feasibility for use of CBT4CBT in a residential treatment program for women with SUDs; 2) Conduct a small RCT comparing TAU with access to the CBT4CBT program (CBT4CBT; intervention) vs. treatment as usual (TAU; control) using relapse rates and days of use as primary treatment outcomes; 3) Exploratory analyses will identify other correlates (e.g., coping strategies, depression) of relapse at 4 and 12 weeks post-discharge.

Registry
clinicaltrials.gov
Start Date
October 4, 2018
End Date
January 18, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ≥18 years of age
  • Meet DSM-5 criteria for a SUD (current)
  • Own a smartphone
  • Can return to facility for the 4 and 12-week follow-up visits.

Exclusion Criteria

  • Cognitive or psychiatric impairment
  • Language barriers that preclude informed consent

Outcomes

Primary Outcomes

Days of Use

Time Frame: 12-week follow-up period

Number of days of any substance use in 12 weeks post-discharge.

Any Relapse

Time Frame: 12-week follow-up period

Percent of participants experiencing any relapse (yes/no), defined as any substance use (alcohol or other drugs) by self-report (smartphone or in person) and/or urine drug toxicology or Breathalyzer during 12-week follow-up period.

Secondary Outcomes

  • Time to Relapse:(12-week follow-up period)

Study Sites (1)

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