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CBT4CBT for Women in Residential Treatment for Substance Use Disorders

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT03678051
Collaborator
(none)
63
Enrollment
1
Location
2
Arms
15.5
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Treatment as Usual (TAU)
  • Behavioral: TAU+CBT4CBT
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Trial of CBT4CBT for Women in Residential Treatment for Substance Use Disorders
Actual Study Start Date :
Oct 4, 2018
Actual Primary Completion Date :
Jan 18, 2020
Actual Study Completion Date :
Jan 18, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment as Usual (TAU)

Standard of care

Behavioral: Treatment as Usual (TAU)
Standard of care residential treatment
Experimental: TAU+CBT4CBT

TAU with access to the CBT4CBT program

Behavioral: Treatment as Usual (TAU)
Standard of care residential treatment

Behavioral: TAU+CBT4CBT
45-minute web-based modules covering core concepts to substance use treatment. The information is presented via graphics and voiceovers and key concepts are illustrated with brief videos depicting the material. Participants will be scheduled for a minimum of two sessions/week over the 3.5 weeks post-randomization (7 modules). These seven sessions will provide protected time to access the interventions, but the women will be able to access the modules and complete homework as much as they wish.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. Days of Use [12-week follow-up period]

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

Secondary Outcome Measures

  1. Time to Relapse: [12-week follow-up period]

    Number of days post discharge to first use of any substance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Exclusion Criteria:

  • Pregnant

  • Cognitive or psychiatric impairment

  • Language barriers that preclude informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University

Investigators

  • Principal Investigator: Dace Svikis Pickens, PhD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT03678051
Other Study ID Numbers:
  • HM20012674
First Posted:
Sep 19, 2018
Last Update Posted:
Feb 5, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Behavior, Addictive

Study Results

No Results Posted as of Feb 5, 2020