Cognitive Behavioral and Faith Fellowship to Improve Thy Health

Last updated: October 24, 2024
Sponsor: University of Wisconsin, Madison
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)

Clinical Study ID

NCT06292637
2020-1484
Protocol Version 4/4/2024
A545000
Protocol Version 1/30/2024
NUR/FACULTY AFFAIRS/ADMIN
1R01HS029477-01
Protocol Version 2/23/2024
  • Ages > 18
  • All Genders

Study Summary

Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American adults in Wisconsin. Twelve church groups, each with 10 people (N=120) will be invited to participate. This intervention will be the first evidence-based, faith-based intervention designed for African Americans if validated.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • self-identify as an African American man or woman

  • are ages 18 and older

  • have symptoms of major depressive disorder, as evidenced by score of 10 and higherfrom the Patient Health Questionnaire-9 (PHQ-9).

Exclusion

Exclusion Criteria:

  • major psychotic illnesses, such as schizophrenia;

  • current participation in psychotherapy

  • current suicidal ideations (trained staff will conduct a suicide risk assessment andfacilitate referral for appropriate care).

  • Medication stabilization. Eligible participants who report recent changes to theirpsychiatric medications (i.e., initiation of a new medication, change in dose ortype of medication) will delay their study enrollment for a stabilization period of 4 weeks. Baseline data collection will be re-administered

  • alcohol or drug dependence - those with alcohol or other drug dependence who havebeen clean and sober for 3 months will not be excluded

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)
Phase:
Study Start date:
October 08, 2024
Estimated Completion Date:
September 30, 2026

Study Description

The randomized stepped wedge design (R-SWD) is a type of cluster randomized controlled trial in which the unit of randomization is a cluster (e.g., church groups with a group of 10 participants), not individual participants. At the start of a R-SWD, all clusters begin as control groups. At certain time points during the course of the trial, some of the clusters are randomly selected to be switched to the Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) treatment, with all clusters eventually crossing over to receive the treatment.

Primary Aim 1: Examine efficacy of CB-FAITH in reducing symptoms of depression.

Secondary Aim 1: Examine moderating effects of religiosity on treatment effectiveness.

Secondary Aim 2: Evaluate satisfaction with CB-FAITH delivered in church settings.

Impact: CB-FAITH is poised to be the first evidence-based faith-based depression intervention designed for African American adults with depression. This community-prioritized research and transformative intervention has potential to reduce depression symptoms, reduce mental health disparities and advance health equity. Given the impact of COVID-19 pandemic, CB-FAITH is critically needed.

Connect with a study center

  • Second Baptist Church

    Madison, Wisconsin 53711-3800
    United States

    Active - Recruiting

  • The Board of Regents of the UW System

    Madison, Wisconsin 53715-1218
    United States

    Active - Recruiting

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