Feasibility of Providing Computerized CBT in the Black Church

NCT03579290 | Completed Results DMC

• 3 other identifiers: 2000022733KL2TR0018625R25DA035163-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator will conduct a pilot study evaluating the feasibility and acceptability of providing a computer-based program (CBT4CBT), used for the treatment of substance use disorders, in a church setting.

Conditions

Substance Abuse

Outcome Measures

Primary Outcomes (3)

• Recruitment Feasibility

  Feasibility is a composite variable (yes/no indicator). This will be determined by counting the number of participants completing the CBT4CBT intervention with significant reductions in drug use, as measured by mean change scores in the severity and quantity of substance use, and functioning over the course of treatment.

  8 weeks

• Program Acceptability

  Acceptability of treatment will be assessed by giving each participant a post-intervention satisfaction survey that assesses satisfaction with the intervention, perception of outcome, attitudes about spiritual practices accompanying CBT4CBT modules, and whether the participant would recommend this program to a friend. To evaluate the acceptability of CBT4CBT with BSUD in a church setting and to identify if religious behaviors led by trained church based health advisors (CHA), may increase the likely suitability of this intervention within the Black church.

  8 weeks

• Sessions Attended

  To determine the feasibility of the program, the mean number of sessions attended was calculated per participant. The maximum number of sessions that could be attended was 7. A missed session could be made up in an additional week. The program lasted 8 weeks.

  8 weeks

Study Arms (1)

CBT4CBT program

EXPERIMENTAL

The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual: Understanding and changing patterns of drug use, Coping with craving, Substance refusal skills, Seemingly irrelevant decisions, Planning for emergencies, and Problem-solving skills. Staying Safe

Behavioral: CBT4CBT program

Interventions

CBT4CBT program BEHAVIORAL

The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual: * Understanding and changing patterns of drug use, * Coping with craving, * Substance refusal skills, * Seemingly irrelevant decisions, * Planning for emergencies, and * Problem-solving skills. * Staying Safe

CBT4CBT program

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age
• Has at least one SUD diagnosis as defined by the DSM 5

You may not qualify if:

• Are unable provide informed consent or participate in the study procedures as proposed in the consent
• Active suicidal or homicidal ideation
• Current engagement in substance use treatment
• Have a current legal case pending, such that incarceration during the 8 week protocol is likely
• Are in need of detoxification from alcohol, opioids or benzodiazepines

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Dixwell Ave Congregational United Church of Christ

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Theresa Babuscio Data Manager
• Organization: Yale University

theresa.babuscio@yale.edu

203-737-5430

Study Officials

• Ayana Jordan, MD; PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: July 6, 2018
• Study Start: May 24, 2018
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: March 8, 2024
• Results First Posted: February 25, 2021

Record last verified: 2024-03

Locations

US (1)