Clinical trial NCT04580810: Black Church Treatment Study
Official title: Addressing Health Disparities by Providing Evidence-Based Treatment in the Black Church
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-10-08
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Rates of treatment initiation
timeFrame: 8 weeks
measure: Rates of engagement in treatment
timeFrame: 8 weeks
measure: Percent days abstinent from alcohol
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Beulah Heights First Pentecostal Church
state: Connecticut
city: New Haven
country: United States
facility: Dixwell Ave Congregational United Church of Christ
state: Connecticut
city: New Haven
country: United States
facility: The Substance Abuse Training Unit (SATU)
state: Connecticut
Study officials:
affiliation: NYU Langone Health
name: Ayana Jordan, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References: