Substance AbuseNCT03579290

Feasibility of Providing Computerized CBT in the Black Church

A study testing CBT4CBT program in people with Substance Abuse, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Substance Abuse
What is being tested?: CBT4CBT program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 24 May 2018to 30 Oct 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Dixwell Ave Congregational United Church of Christ
New Haven, Connecticut, 06511

Other trials in United States

About this study

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

Read the detailed 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.

Conditions: Substance Abuse
Being tested: CBT4CBT program
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBT4CBT programBehavioural
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

Study groups in NCT03579290
Study group	Role	What they receive
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 Receives: Behavioral: CBT4CBT program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 201830 Oct 2018

First posted6 Jul 2018
Study start24 May 2018
Primary completion30 Oct 2018
Study completion30 Oct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Substance AbuseStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03579290
Sponsor's protocol ID: 2000022733
Other IDs: KL2TR001862, 5R25DA035163-03
Status last verified: Mar 2024
First submitted: 1 Jun 2018
Last updated: 8 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Feasibility Study of Providing Substance Use Treatment in the Black Church
ClinicalTrials.gov ID: NCT03579290
Acronym / sponsor ID: 2000022733
Conditions: Substance Abuse
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
Study start: 24 May 2018 (actual)
Primary completion: 30 Oct 2018 (actual)
Study completion: 30 Oct 2018 (actual)
First posted: 6 Jul 2018 (actual)
Results: Posted 25 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CBT4CBT program	Experimental	Behavioral: CBT4CBT programThe '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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CBT4CBT programThe '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	Behavioural	CBT4CBT program

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 25 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CBT4CBT Program	40	31

Primary outcome: Recruitment Feasibility

Time frame: 8 weeks

Population analysed: This outcome measure was never collected.

Primary outcome: Program Acceptability

Time frame: 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	CBT4CBT Program n = 31
Overall Satisfaction (1-5) Very satisfied to very dissatisfied	1.6 (0.89)
Describe current condition at present (1-5) excellent to poor	1.7 (.66)
How have you changed (1-5) much worse to much better better	3.8 (1.2)
Are you worse, unchanged or better (1-3)	2.6 (3.8)
Are you better due to tx in Black Church (1-5) Definitely not related to definitely related	3.1 (1.5)
Satisfaction with amount of tx received (1-5) very satisfied to very dissatisfied	1.9 (1.2)
How satisfied were you with the CBT program (1-6) very satisfied to very dissatisfied	1.6 (1.0)
If seeking future tx, would you return to CBT program (1-5) Definitely to definitley not	1.4 (.72)

Population analysed: Participants that completed the program.

Primary outcome: Sessions Attended

Time frame: 8 weeks. Mean (Standard Deviation). Unit: sessions

Measure	CBT4CBT Program n = 40
Value	6.8 (1.9)

Adverse events

Time frame: 8 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CBT4CBT Program	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ayana Jordan, MD; PhD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CBT4CBT program in people with Substance Abuse, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Feasibility (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03579290.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.