Clinical trial NCT03678051: CBT4CBT for Women in Residential Treatment for Substance Use Disorders
Official title: A Randomized Trial of CBT4CBT for Women in Residential Treatment for Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Drug Abuse
Drug Addiction
Substance Abuse
Drug Use Disorders
Drug Dependence
Substance Addiction
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Any Relapse
timeFrame: 12-week follow-up period
measure: Days of Use
timeFrame: 12-week follow-up period
Secondary outcomes:
measure: Time to Relapse:
timeFrame: 12-week follow-up period
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Dace Svikis Pickens, PhD
role: PRINCIPAL_INVESTIGATOR
References: