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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR001862 | U.S. NIH Grant/Contract | View source | |
| 5R25DA035163-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayana Jordan, MD; PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dixwell Ave Congregational United Church of Christ | New Haven | Connecticut | 06511 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This outcome measure was never collected. | Posted | 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theresa Babuscio Data Manager | Yale University | 203-737-5430 | theresa.babuscio@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2019 | Dec 1, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 3, 2020 | Dec 3, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2018 | Feb 13, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| DSM 5 checklist for substance use disorders | Symptoms endorsement mild 2-3 moderate (4-5) severe (6+) | Count of Participants | Participants |
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| Substance Use Calendar | Mean number of days of self report use of alcohol, cocaine, marijuana, opioids, benzodiazepine, heroin, nicotine for the 28 days previous to baseline. | Mean | Standard Deviation | days |
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| Number of Participants Testing Positive for Substance | Urine toxicology screening performed by Confirm Biosciences, 12 panel, confirm insta-cup, Alcohol (EtG), Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Cocaine (COC), Marijuana (THC), Methadone (MTD), Methamphetamine (mAMP), Ecstasy/Molly (MDMA), Opiate (OPI), Buprenorphine (BUP), Oxycodone (OXY)]. | Count of Participants | Participants |
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| 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. | Participants that completed the program. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
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| 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. | Posted | Mean | Standard Deviation | sessions | 8 weeks |
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| 0 |
| 40 |
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| 40 |
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| 40 |
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| Are you worse, unchanged or better (1-3) |
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| Are you better due to tx in Black Church (1-5) Definitely not related to definitely related |
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| Satisfaction with amount of tx received (1-5) very satisfied to very dissatisfied |
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| How satisfied were you with the CBT program (1-6) very satisfied to very dissatisfied |
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| If seeking future tx, would you return to CBT program (1-5) Definitely to definitley not |
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| Has this tx program met your need (1-5) almost all needs to none of my needs |
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| What will be drug and alcohol use in the next month (1-6) not use any to use daily |
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| Able to do homework after watching example (1-5) strongly disagree to strongly agree |
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| Homework helped me understand my drug and alcohol use (1-6) strongly disagree to strongly agree |
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| Homework helped give me tools to help drug problem (1-6) strongly disagree to strongly agree |
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| Satisfied with general content of CBT program (1-5) strongly dissatisfied to strongly satisfied |
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| Satisfied with ability to learn from CBT program (1-5) strongly dissatisfied to strongly satisfied |
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| Rating for computer facilitated program as tool for learning (1-5) very poor to excellent |
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