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Black Church Treatment Study

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT4CBT in the Black Church
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • at least 18 years of age
  • current AUD as their principal substance use disorder, confirmed via MINI100 interview, with some drinking in the past 28 days
  • English-speaking

Exclusion Criteria:

  • inability to provide informed consent or participate in the study procedures as proposed in the consent
  • active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder),
  • current engagement in substance use treatment, and
  • an unwillingness to be randomized to either condition. Individuals with comorbid substance use disorders will be included, as multiple substances of use are common in this population.

Sites / Locations

  • Beulah Heights First Pentecostal ChurchRecruiting
  • Dixwell Ave Congregational United Church of ChristRecruiting
  • The Substance Abuse Training Unit (SATU)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBT4CBT in the Black Church

Community Based Treatment as Usual

Arm Description

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 alcohol use, Coping with craving, Substance refusal skills, Seemingly irrelevant decisions, Planning for emergencies, and Problem-solving skills. Staying Safe

Treatment as usual, typically groups, offered by a specialty community based treatment center (MCCA)

Outcomes

Primary Outcome Measures

Rates of treatment initiation
Rates of treatment initiation as measured by proportion of participants completing at least one session at the assigned site
Rates of engagement in treatment
Rates of engagement in treatment operationalized by proportion retained at the 4-week point at the assigned site
Percent days abstinent from alcohol
Percent days abstinent from alcohol operationalized by Timeline Follow Back

Secondary Outcome Measures

Full Information

First Posted
October 7, 2020
Last Updated
July 25, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04580810
Brief Title
Black Church Treatment Study
Official Title
Addressing Health Disparities by Providing Evidence-Based Treatment in the Black Church
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will conduct a randomized clinical trial comparing levels of treatment initiation, engagement, and alcohol outcomes for a novel treatment strategy (CBT4CBT delivered in the Black church) compared with traditional outpatient specialty addiction treatment for a large sample of Black adults with AUD. The purpose of this randomized clinical trial is to determine which setting (church or specialty clinic) (1) has better treatment initiation and retention rates and (2) better AUD outcomes as measured by percentage of days abstinent (PDA) (8 weeks, 3, 6 and 9 months follow up).
Detailed Description
This study is a randomized control trial focusing on rates of treatment initiation, engagement, and outcome in Black adults assigned to CBT4CBT in the Black Church relative to the standard of care for this population. This study is focusing on individuals with AUD as the needs assessment indicated that as the most common substance use problem in this setting. Moreover, our focus groups and work with Church staff has indicated that alcohol use is less stigmatized within the Black and the Church communities than other substance use. Thus, while individuals with other substance use will be included, positioning the study as focusing primarily on alcohol use will avoid potential issues of stigma and thus may facilitate recruitment. Selecting a comparison condition for this novel intervention strategy is complex. As the primary rationale for delivering treatment in the Black church setting is that this national network is seen as a trusted institution in the Black community, our research questions center around (1) whether delivering CBT4CBT in the Black church is a safe and effective alternative to standard care, (2) whether it engages and retains individuals better than standard specialty care, (3) the extent to which this strategy reaches individuals who would not otherwise seek treatment for AUD, (4) what kinds of individuals are particularly suited to this setting, and (5) the relative costs of this novel form of treatment delivery. Thus, a standard specialty care at Midwestern Connecticut Council on Alcohol (MCCA) as the comparison condition was selected. MCCA is a non-profit, community-based provider in the predominantly Black Dixwell neighborhood, not far from Dixwell Church and has a positive reputation in the Black community. The primary treatment modality is group therapy. In 2019, MCCA treated over 500 unique individuals (44% female, 35% African American, 20% Latino). MCCA staff are diverse and multidisciplinary. Clinic Director Steven Palma has agreed to provide a dedicated triage slot for this study so individuals can be admitted and assigned a group within one week, reducing a key barrier. The two study settings will be balanced in several ways, with few barriers to care, both in the same neighborhood, and assignment of participants to a group within one week of randomization, thus preserving equipoise and balancing attractiveness of both sites to participants as much as possible. They will differ primarily in setting (church versus specialty care), in treatment content (CBT4CBT with spirituality elements versus group treatment with some CBT content), and group leaders (CHAs versus masters-level staff).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT4CBT in the Black Church
Arm Type
Experimental
Arm Description
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 alcohol use, Coping with craving, Substance refusal skills, Seemingly irrelevant decisions, Planning for emergencies, and Problem-solving skills. Staying Safe
Arm Title
Community Based Treatment as Usual
Arm Type
No Intervention
Arm Description
Treatment as usual, typically groups, offered by a specialty community based treatment center (MCCA)
Intervention Type
Behavioral
Intervention Name(s)
CBT4CBT in the Black Church
Intervention Description
Use of Computer Based Treatment for Cognitive Behavioral Therapy for alcohol use disorder offered in a Black church setting
Primary Outcome Measure Information:
Title
Rates of treatment initiation
Description
Rates of treatment initiation as measured by proportion of participants completing at least one session at the assigned site
Time Frame
8 weeks
Title
Rates of engagement in treatment
Description
Rates of engagement in treatment operationalized by proportion retained at the 4-week point at the assigned site
Time Frame
8 weeks
Title
Percent days abstinent from alcohol
Description
Percent days abstinent from alcohol operationalized by Timeline Follow Back
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least 18 years of age current AUD as their principal substance use disorder, confirmed via MINI100 interview, with some drinking in the past 28 days English-speaking Exclusion Criteria: inability to provide informed consent or participate in the study procedures as proposed in the consent active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder), current engagement in substance use treatment, and an unwillingness to be randomized to either condition. Individuals with comorbid substance use disorders will be included, as multiple substances of use are common in this population.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Traci Norman
Phone
203-833-4267
Email
Traci.Norman@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayana Jordan, MD, PhD.
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beulah Heights First Pentecostal Church
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blanche Tucker
Phone
203-996-2061
Email
blanche.tucker@sbcglobal.net
Facility Name
Dixwell Ave Congregational United Church of Christ
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fredrick Streets
Phone
203-787-5839
Email
ayana.jordan@yale.edu
Facility Name
The Substance Abuse Training Unit (SATU)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Lapaglia
Phone
203-974-5734
Email
donna.lapaglia@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Black Church Treatment Study

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