Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HS029477-01 | U.S. AHRQ Grant/Contract | View source | |
| A545000 | Other Identifier | UW Madison | |
| NUR/FACULTY AFFAIRS/ADMIN | Other Identifier | UW Madison | |
| Protocol Version 9/5/2025 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| CB-FAITH treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Earlise Ward, PhD | Contact | 608/263-0745 | ecward@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Earlise Ward, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Recruiting | Madison | Wisconsin | 53515 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
|
| baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months |
| 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) |
| Second Baptist Church | Recruiting | Madison | Wisconsin | 53711-3800 | United States |
|
| The Board of Regents of the UW System | Recruiting | Madison | Wisconsin | 53715-1218 | United States |
|