Cognitive Behavioral and Faith Fellowship to Improve Thy Health

Depression Clinical Trial

— CB-FAITH  

Official title:

Cognitive Behavioral and Faith Fellowship to Improve Thy Health (CB-FAITH) - A Feasibility and Acceptability Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06292637
• Other study ID #: 2020-1484
• Secondary ID: A545000NUR/FACUL
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2026

Study information

• Verified date: May 2024
• Source: University of Wisconsin, Madison
• Contact: Earlise Ward, PhD
• Phone: 608/263-0745
• Email: ecward[@]wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Second Baptist Church	Madison	Wisconsin
United States	The Board of Regents of the UW System	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Multidimensional Measure of Religious Involvement (MMRI) score	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.	baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
Secondary	Client Satisfaction Inventory (CSI) score	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.	approximately Week 13-16 (End of CB-FAITH classes)