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Completed

NCT Number: NCT03579290

Feasibility of Providing Computerized CBT in the Black Church

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.

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Key information

Conditions

Substance Abuse Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dixwell Ave Congregational United Church of Christ

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Recruitment Feasibility

    Time frame: 8 weeks

    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.

  2. Program Acceptability

    Time frame: 8 weeks

    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.

  3. Sessions Attended

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2018
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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