CBT4CBT for Women in Residential Treatment for Substance Use Disorders

NCT ID: NCT03678051

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-04
• Study Completion Date: 2020-01-18

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.

Conditions

Substance Use Disorders; Drug Abuse; Drug Addiction; Substance Abuse; Drug Use Disorders; Drug Dependence; Substance Addiction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment as Usual (TAU)

Standard of care

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Standard of care residential treatment

TAU+CBT4CBT

TAU with access to the CBT4CBT program

Group Type: EXPERIMENTAL

Treatment as Usual (TAU)

Intervention Type: BEHAVIORAL

Standard of care residential treatment

TAU+CBT4CBT

Intervention Type: BEHAVIORAL

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.

Interventions

Treatment as Usual (TAU)

Standard of care residential treatment

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dace Svikis Pickens, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

References

Parlier-Ahmad AB, Kelpin S, Martin CE, Svikis DS. Baseline Characteristics and Postdischarge Outcomes by Medication for Opioid Use Disorder Status Among Women with Polysubstance Use in Residential Treatment. Womens Health Rep (New Rochelle). 2023 Dec 15;4(1):617-626. doi: 10.1089/whr.2023.0082. eCollection 2023.

Reference Type: DERIVED

PMID: 38145229 (View on PubMed)

Other Identifiers

HM20012674

Identifier Type: -

Identifier Source: org_study_id