DepressionCB-FAITHNCT06292637
Cognitive Behavioral and Faith Fellowship to Improve Thy Health
A study testing Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) in people with Depression, run by University of Wisconsin, Madison at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Oct 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Wisconsin - Madison
Madison, Wisconsin, 53515
Second Baptist Church
Madison, Wisconsin, 53711-3800
The Board of Regents of the UW System
Madison, Wisconsin, 53715-1218
About this study
Official title: Cognitive Behavioral and Faith Fellowship to Improve Thy Health (CB-FAITH) - A Feasibility and Acceptability Study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)
- Keywords
- faith-based intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| CB-FAITH treatment | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: approximately Week 13-16 (End of CB-FAITH classes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start8 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Earlise Ward, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292637
- Sponsor's protocol ID
- 2020-1484
- Other IDs
- 1R01HS029477-01, A545000, NUR/FACULTY AFFAIRS/ADMIN, Protocol Version 9/5/2025
- Acronym
- CB-FAITH
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral and Faith Fellowship to Improve Thy Health (CB-FAITH) - A Feasibility and Acceptability Study
- ClinicalTrials.gov ID
- NCT06292637
- Acronym / sponsor ID
- CB-FAITH / 2020-1484
- Conditions
- Depression
- Keywords
- faith-based intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| CB-FAITH treatment | Experimental | Behavioral: Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CB-FAITH treatment |
Primary outcome
Patient Health Questionnaire
Time frame: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
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.
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
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.
2 secondary outcomes
Multidimensional Measure of Religious Involvement (MMRI) score
Time frame: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
Client Satisfaction Inventory (CSI) score
Time frame: approximately Week 13-16 (End of CB-FAITH classes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Earlise Ward, PhD principal investigator
University of Wisconsin, Madison
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) in people with Depression, run by University of Wisconsin, Madison at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (time frame: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.