CBT4CBT for Women in Residential Treatment for Substance Use Disorders

Not Applicable

Completed

• Conditions: Substance Use Disorders; Drug Addiction; Substance Abuse; Drug Dependence; Drug Use Disorders; Drug Abuse; Substance Addiction
• Interventions: Behavioral: Treatment as Usual (TAU); Behavioral: TAU+CBT4CBT

• Registration Number: NCT03678051
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-18
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Study Start: 2018-10-04
• Primary Completion: 2020-01-18
• Study Completion: 2020-01-18
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU+CBT4CBT	Treatment as Usual (TAU)	TAU with access to the CBT4CBT program
Treatment as Usual (TAU)	Treatment as Usual (TAU)	Standard of care
TAU+CBT4CBT	TAU+CBT4CBT	TAU with access to the CBT4CBT program

Primary Outcome Measures

Name	Time	Method
Days of Use	12-week follow-up period	Number of days of any substance use in 12 weeks post-discharge.
Any Relapse	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 Outcome Measures

Name	Time	Method
Time to Relapse:	12-week follow-up period	Number of days post discharge to first use of any substance.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States