Substance Abuse
Conditions
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.
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.
Interventions
BEHAVIORALCBT4CBT 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
Sponsors
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | CBT4CBT Program |
|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 9.7 |
| DSM 5 checklist for substance use disorders Mild | 5 Participants |
| DSM 5 checklist for substance use disorders Moderate | 13 Participants |
| DSM 5 checklist for substance use disorders Severe | 22 Participants |
| Number of Participants Testing Positive for Substance Number of positive for Alcohol | 16 Participants |
| Number of Participants Testing Positive for Substance Number positive for Amphetamine | 1 Participants |
| Number of Participants Testing Positive for Substance Number positive for Barbiturates | 2 Participants |
| Number of Participants Testing Positive for Substance Number positive for Benzodiazapines | 0 Participants |
| Number of Participants Testing Positive for Substance Number positive for Buprenorphine | 2 Participants |
| Number of Participants Testing Positive for Substance Number positive for Cocaine | 22 Participants |
| Number of Participants Testing Positive for Substance Number positive for Ecstasy | 3 Participants |
| Number of Participants Testing Positive for Substance Number positive for Marijuana | 16 Participants |
| Number of Participants Testing Positive for Substance Number positive for Methadone | 2 Participants |
| Number of Participants Testing Positive for Substance Number positive for Methamphetamine | 0 Participants |
| Number of Participants Testing Positive for Substance Number positive for Opioids | 4 Participants |
| Number of Participants Testing Positive for Substance Number positive for Oxycodone | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 20 Participants |
| Substance Use Calendar Mean days of alcohol use past 28 days | 17.9 days STANDARD_DEVIATION 10.3 |
| Substance Use Calendar Mean days of benzodiazapine use past 28 days | .31 days STANDARD_DEVIATION 1.3 |
| Substance Use Calendar Mean days of cocaine use past 28 days | 8.9 days STANDARD_DEVIATION 11.9 |
| Substance Use Calendar Mean days of heroin use past 28 days | 3.0 days STANDARD_DEVIATION 8 |
| Substance Use Calendar Mean days of marijuana use past 28 days | 7.6 days STANDARD_DEVIATION 10.6 |
| Substance Use Calendar Mean days opioid use past 28 days | 1.3 days STANDARD_DEVIATION 5 |
| Substance Use Calendar Mean number of days of nicotine use past 28 days | 13.2 days STANDARD_DEVIATION 13 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: 8 weeks
Population: Participants that completed the program.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CBT4CBT Program | Program Acceptability | Overall Satisfaction (1-5) Very satisfied to very dissatisfied | 1.6 units on a scale | Standard Deviation 0.89 |
| CBT4CBT Program | Program Acceptability | Describe current condition at present (1-5) excellent to poor | 1.7 units on a scale | Standard Deviation 0.66 |
| CBT4CBT Program | Program Acceptability | How have you changed (1-5) much worse to much better better | 3.8 units on a scale | Standard Deviation 1.2 |
| CBT4CBT Program | Program Acceptability | Are you worse, unchanged or better (1-3) | 2.6 units on a scale | Standard Deviation 3.8 |
| CBT4CBT Program | 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 |
| CBT4CBT Program | 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 |
| CBT4CBT Program | 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 |
| CBT4CBT Program | 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 0.72 |
| CBT4CBT Program | 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 |
| CBT4CBT Program | 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 |
| CBT4CBT Program | 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 |
| CBT4CBT Program | 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 |
| CBT4CBT Program | 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 |
| CBT4CBT Program | Program Acceptability | Satisfied with general content of CBT program (1-5) strongly dissatisfied to strongly satisfied | 3.7 units on a scale | Standard Deviation 0.95 |
| CBT4CBT Program | 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 |
| CBT4CBT Program | 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 0.97 |
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.
Time frame: 8 weeks
Population: This outcome measure was never collected.
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT4CBT Program | Sessions Attended | 6.8 sessions | Standard Deviation 1.9 |