Recruiting

Cognitive Behavioral & Faith Fellowship

Sponsor:

University of Wisconsin, Madison

Code:

NCT06292637

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06292637

Start date

Oct 8, 2024

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

experimental: CB-FAITH treatment

Interventions

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

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.

Primary outcome measure

  • Patient Health Questionnaire [ Time Frame: 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) [ Time Frame: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of Wisconsin - Madison

Recruiting

Madison, Wisconsin, United States, 53515

Contacts

Second Baptist Church

Recruiting

Madison, Wisconsin, United States, 53711-3800

Contacts

Principal Investigator:

Anthony Wade

The Board of Regents of the UW System

Recruiting

Madison, Wisconsin, United States, 53715-1218

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Keywords

  • faith-based intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2025-09-30.