CBT4CBT for Women in Residential Treatment for Substance Use Disorders

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03678051
• Other study ID #: HM20012674
• Status: Completed
• Phase: N/A
• Start date: October 4, 2018
• Est. completion date: January 18, 2020

Study information

• Verified date: February 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: January 18, 2020
• Est. primary completion date: January 18, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Disease
• Drug Abuse
• Drug Addiction
• Drug Dependence
• Drug Use Disorders
• Substance Abuse
• Substance Addiction
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any Relapse	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.	12-week follow-up period
Primary	Days of Use	Number of days of any substance use in 12 weeks post-discharge.	12-week follow-up period
Secondary	Time to Relapse:	Number of days post discharge to first use of any substance.	12-week follow-up period