Cognitive Behavioral and Faith Fellowship to Improve Thy Health

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Behavioral: Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)

• Registration Number: NCT06292637
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-05
• Status Verified: 2024-10
• Study Start: 2024-10-08
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 higher from the Patient Health Questionnaire-9 (PHQ-9).

Exclusion Criteria

• major psychotic illnesses, such as schizophrenia;
• current participation in psychotherapy
• current suicidal ideations (trained staff will conduct a suicide risk assessment and facilitate referral for appropriate care).
• Medication stabilization. Eligible participants who report recent changes to their psychiatric medications (i.e., initiation of a new medication, change in dose or type 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 have been clean and sober for 3 months will not be excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CB-FAITH treatment	Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)	-

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire	baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months	Patient Health Questionnaire-9 (PHQ-9) is a self-administered depression scale (5 minute completion time), which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day).; Categories of depression symptoms are defined as none (score 0-4), mild (score 5-9), moderate (score 10-14), moderately severe (score 15-19), and severe (score ≥20). In addition to making criteria-based diagnoses of depressive disorders, the PHQ-9 is also a reliable and valid measure of depression severity.
Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR)	baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months	The 16-item Quick Inventory of Depressive Symptomatology (QIDS) assesses depressive symptom severity and symptom change. Investigators will use the clinician rated QIDS-CR. Scores range from 0-27 and higher scores suggest higher severity of depression.

Secondary Outcome Measures

Name	Time	Method
Multidimensional Measure of Religious Involvement (MMRI) score	baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months	Religiosity will be measured with the Multidimensional Measure of Religious Involvement (MMRI), a three-dimensional measure of religious involvement, consisting of organizational (frequency of service attendance), non-organizational (use of and frequency of nonorganized activities, such as watching religious programs on TV), and subjective religiosity (self-rated level of religiosity, such as significance of prayer and orientation toward God).; It consists of 12 items and is self administered (5-10-minute completion time). Using Likert-scale responses, ranging from: 1 = very religious, 2 = fairly religious, 3 = not too religious, and 4 = not religious at all.
Client Satisfaction Inventory (CSI) score	approximately Week 13-16 (End of CB-FAITH classes)	Client Satisfaction Inventory (CSI), an 8-item measure of satisfaction with counseling; total scores range from 8 to 32, with the higher number indicating greater satisfaction. The CSI will be self-administered.

Trial Locations

Locations (2)

Second Baptist Church; 🇺🇸 Madison, Wisconsin, United States

The Board of Regents of the UW System; 🇺🇸 Madison, Wisconsin, United States