Clinical trial NCT06292637: Cognitive Behavioral and Faith Fellowship to Improve Thy Health
Official title: Cognitive Behavioral and Faith Fellowship to Improve Thy Health (CB-FAITH) - a Feasibility and Acceptability Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: faith-based intervention
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2024-03-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire
timeFrame: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
measure: Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR)
timeFrame: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
Secondary outcomes:
measure: Multidimensional Measure of Religious Involvement (MMRI) score
timeFrame: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
measure: Client Satisfaction Inventory (CSI) score
timeFrame: approximately Week 13-16 (End of CB-FAITH classes)
Other outcomes:
Locations:
city: Madison
country: United States
facility: Second Baptist Church
state: Wisconsin
city: Madison
country: United States
facility: The Board of Regents of the UW System
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Earlise Ward, PhD
role: PRINCIPAL_INVESTIGATOR
References: