Feasibility of Providing Computerized CBT in the Black Church

Substance Abuse Clinical Trial

Official title:

A Pilot Feasibility Study of Providing Substance Use Treatment in the Black Church

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03579290
• Other study ID #: 2000022733
• Secondary ID: KL2TR0018625R25D
• Status: Completed
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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. Forty Black adults with a current DSM-5 alcohol or substance use disorder will utilize the 'CBT for CBT' program over a period of 8 weeks. Primary outcomes will be acceptability and feasibility of providing the treatment in a church setting. If found to be acceptable and feasible, with preliminary promise for reductions in substance use, the next step would be to adapt the computer intervention for this population and conduct a randomized controlled trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Has at least one SUD diagnosis as defined by the DSM 5

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• CBT4CBT program
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

Locations

Country	Name	City	State
United States	Dixwell Ave Congregational United Church of Christ	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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