Cognitive Behavioral and Faith Fellowship to Improve Thy Health

NCT06292637 | Recruiting

• 5 other identifiers: 2020-14841R01HS029477-01A545000NUR/FACULTY AFFAIRS/ADMINProtocol Version 9/5/2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Depression

Keywords

faith-based intervention

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire

  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.

  baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months

• Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR)

  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.

  baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months

Secondary Outcomes (2)

• Multidimensional Measure of Religious Involvement (MMRI) score

  baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months

• Client Satisfaction Inventory (CSI) score

  approximately Week 13-16 (End of CB-FAITH classes)

Study Arms (2)

Control

NO INTERVENTION

CB-FAITH treatment

EXPERIMENTAL

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

Interventions

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

CB-FAITH is a behavioral depression intervention set inside a cognitive behavioral framework, and Afrocentric paradigm and informed by faith-based principles, designed to treat major depressive disorder among African American adults. The 13-treatment modules focus on increasing knowledge of depression and healthy coping behaviors. It is designed to be co-delivered by licensed mental health clinicians and pastors at churches.

CB-FAITH treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (3)

University of Wisconsin - Madison

Madison, Wisconsin, 53515, United States

RECRUITING

Second Baptist Church

Madison, Wisconsin, 53711-3800, United States

RECRUITING

The Board of Regents of the UW System

Madison, Wisconsin, 53715-1218, United States

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Earlise Ward, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Earlise Ward, PhD

CONTACT

608/263-0745; ecward@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized stepped wedge design (R-SWD), a type of cluster randomized controlled trial, will be used to randomize a cluster (church groups with a group of 10 participants), not individual subjects. 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 CB-FAITH treatment, with all clusters eventually crossing over to receive the treatment. The sample will be comprised of 12 groups, each with 10 individuals (N=120).

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)