CBT4CBT for Women in Residential Treatment for Substance Use Disorders

NCT03678051 | Completed

• 1 other identifier: HM20012674
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• Days of Use

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

  12-week follow-up period

Secondary Outcomes (1)

• Time to Relapse:

  12-week follow-up period

Study Arms (2)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Standard of care

Behavioral: Treatment as Usual (TAU)

TAU+CBT4CBT

EXPERIMENTAL

TAU with access to the CBT4CBT program

Behavioral: Treatment as Usual (TAU); Behavioral: TAU+CBT4CBT

Interventions

Treatment as Usual (TAU) BEHAVIORAL

Standard of care residential treatment

TAU+CBT4CBT; Treatment as Usual (TAU)

TAU+CBT4CBT 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.

TAU+CBT4CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 38145229 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Dace Svikis Pickens, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 19, 2018
• Study Start: October 4, 2018
• Primary Completion: January 18, 2020
• Study Completion: January 18, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)