Trial Outcomes & Findings for Feasibility of Providing Computerized CBT in the Black Church (NCT NCT03579290)
NCT ID: NCT03579290
Last Updated: 2024-03-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
8 weeks
Results posted on
2024-03-08
Participant Flow
Recruitment occurred June through August of 2018. Participants were recruited from flyers distributed at local churches and from community services in the New Haven area. The flyers were developed with the Yale Center for Clinical Investigation (YCCI) to be culturally appropriate, and featured images of Black adults.
Participant milestones
| Measure |
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
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
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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
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
|
|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
Baseline Characteristics
Feasibility of Providing Computerized CBT in the Black Church
Baseline characteristics by cohort
| Measure |
CBT4CBT Program
n=40 Participants
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: 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
|
|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=99 Participants
|
|
DSM 5 checklist for substance use disorders
Mild
|
5 Participants
n=99 Participants
|
|
DSM 5 checklist for substance use disorders
Moderate
|
13 Participants
n=99 Participants
|
|
DSM 5 checklist for substance use disorders
Severe
|
22 Participants
n=99 Participants
|
|
Substance Use Calendar
Mean days of alcohol use past 28 days
|
17.9 days
STANDARD_DEVIATION 10.3 • n=99 Participants
|
|
Substance Use Calendar
Mean days of cocaine use past 28 days
|
8.9 days
STANDARD_DEVIATION 11.9 • n=99 Participants
|
|
Substance Use Calendar
Mean days opioid use past 28 days
|
1.3 days
STANDARD_DEVIATION 5.0 • n=99 Participants
|
|
Substance Use Calendar
Mean days of marijuana use past 28 days
|
7.6 days
STANDARD_DEVIATION 10.6 • n=99 Participants
|
|
Substance Use Calendar
Mean days of benzodiazapine use past 28 days
|
.31 days
STANDARD_DEVIATION 1.3 • n=99 Participants
|
|
Substance Use Calendar
Mean days of heroin use past 28 days
|
3.0 days
STANDARD_DEVIATION 8.0 • n=99 Participants
|
|
Substance Use Calendar
Mean number of days of nicotine use past 28 days
|
13.2 days
STANDARD_DEVIATION 13.0 • n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number of positive for Alcohol
|
16 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Amphetamine
|
1 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Barbiturates
|
2 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Benzodiazapines
|
0 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Cocaine
|
22 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Marijuana
|
16 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Methadone
|
2 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Methamphetamine
|
0 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Ecstasy
|
3 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Opioids
|
4 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Buprenorphine
|
2 Participants
n=99 Participants
|
|
Number of Participants Testing Positive for Substance
Number positive for Oxycodone
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: This outcome measure was never collected.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 8 weeksPopulation: Participants that completed the program.
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.
Outcome measures
| Measure |
CBT4CBT Program
n=31 Participants
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: 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
|
|---|---|
|
Program Acceptability
Overall Satisfaction (1-5) Very satisfied to very dissatisfied
|
1.6 units on a scale
Standard Deviation 0.89
|
|
Program Acceptability
Describe current condition at present (1-5) excellent to poor
|
1.7 units on a scale
Standard Deviation .66
|
|
Program Acceptability
How have you changed (1-5) much worse to much better better
|
3.8 units on a scale
Standard Deviation 1.2
|
|
Program Acceptability
Are you worse, unchanged or better (1-3)
|
2.6 units on a scale
Standard Deviation 3.8
|
|
Program Acceptability
Are you better due to tx in Black Church (1-5) Definitely not related to definitely related
|
3.1 units on a scale
Standard Deviation 1.5
|
|
Program Acceptability
Satisfaction with amount of tx received (1-5) very satisfied to very dissatisfied
|
1.9 units on a scale
Standard Deviation 1.2
|
|
Program Acceptability
How satisfied were you with the CBT program (1-6) very satisfied to very dissatisfied
|
1.6 units on a scale
Standard Deviation 1.0
|
|
Program Acceptability
If seeking future tx, would you return to CBT program (1-5) Definitely to definitley not
|
1.4 units on a scale
Standard Deviation .72
|
|
Program Acceptability
Has this tx program met your need (1-5) almost all needs to none of my needs
|
2.1 units on a scale
Standard Deviation 1.1
|
|
Program Acceptability
What will be drug and alcohol use in the next month (1-6) not use any to use daily
|
2.0 units on a scale
Standard Deviation 1.3
|
|
Program Acceptability
Able to do homework after watching example (1-5) strongly disagree to strongly agree
|
3.5 units on a scale
Standard Deviation 1.1
|
|
Program Acceptability
Homework helped me understand my drug and alcohol use (1-6) strongly disagree to strongly agree
|
4.0 units on a scale
Standard Deviation 1.0
|
|
Program Acceptability
Homework helped give me tools to help drug problem (1-6) strongly disagree to strongly agree
|
4.1 units on a scale
Standard Deviation 1.3
|
|
Program Acceptability
Satisfied with general content of CBT program (1-5) strongly dissatisfied to strongly satisfied
|
3.7 units on a scale
Standard Deviation .95
|
|
Program Acceptability
Satisfied with ability to learn from CBT program (1-5) strongly dissatisfied to strongly satisfied
|
3.7 units on a scale
Standard Deviation 1.0
|
|
Program Acceptability
Rating for computer facilitated program as tool for learning (1-5) very poor to excellent
|
3.8 units on a scale
Standard Deviation .97
|
PRIMARY outcome
Timeframe: 8 weeksTo 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.
Outcome measures
| Measure |
CBT4CBT Program
n=40 Participants
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: 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
|
|---|---|
|
Sessions Attended
|
6.8 sessions
Standard Deviation 1.9
|
Adverse Events
CBT4CBT Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place