NCT06292637 · University of Wisconsin, Madison
Cognitive Behavioral and Faith Fellowship to Improve Thy Health
(CB-FAITH)
What this study is about
Investigators will examine the effectiveness 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Madison, Wisconsin
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 30, 2025 · Source of record for eligibility and locations