Faith-Based Program for Depression

(CB-FAITH Trial)

Recruiting at 2 trial locations

Overseen By Earlise Ward, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Schizophrenia, Psychotherapy, Suicidal ideations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a faith-based program can reduce depression symptoms among African American adults in Wisconsin. The program, Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH), will be tested with church groups to assess its effectiveness. Participants include individuals who identify as African American, are 18 or older, and have ongoing symptoms of depression. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mental health support within their community.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you've recently changed your psychiatric medications, you'll need to wait 4 weeks before joining the study.

What prior data suggests that this faith-based program is safe for participants?

Research has shown that faith-based programs, such as the Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH), can help reduce symptoms of depression. Studies indicate that participants generally tolerate these programs well. No reports of serious side effects have emerged from this approach, suggesting it is likely safe for most people. This makes it a promising option for those seeking mental health support that includes faith elements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) because it uniquely combines cognitive behavioral therapy with faith-based principles. Unlike traditional treatments for depression, which often rely on medications like SSRIs or standalone cognitive therapies, CB-FAITH integrates spiritual support with mental health interventions. This approach not only addresses the psychological aspects of depression but also taps into spiritual resources, which can be a powerful motivator for individuals with strong religious beliefs. By incorporating faith into the therapeutic process, CB-FAITH offers a holistic approach that could enhance emotional well-being and provide a sense of community support.

What evidence suggests that the CB-FAITH treatment might be an effective intervention for depression?

Research has shown that combining cognitive-behavioral therapy (CBT) with faith-based elements may help reduce depression symptoms. CBT, a type of talk therapy, is already effective for treating depression. Adding a spiritual approach has also shown promise in easing depressive symptoms. Early evidence suggests that religious cognitive-behavioral therapy (RCBT) can be beneficial in a church setting. In this trial, participants in the CB-FAITH treatment arm will experience this method, called Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH), designed specifically for African American adults to integrate these elements. ^{1 2 3 6 7}

Who Is on the Research Team?

Earlise Ward, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for African American adults in Wisconsin who are experiencing symptoms of depression. Participants will be part of church groups, with a total of 120 individuals across twelve groups being invited to join the study.

Inclusion Criteria

I have symptoms of major depression, confirmed by a PHQ-9 score of 10 or higher.

I identify as an African American.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control

All clusters begin as control groups before being switched to the CB-FAITH treatment

6 weeks

Baseline assessment

Treatment

Clusters are randomly selected to receive the CB-FAITH treatment

6 weeks

Assessments at weeks 6 and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)

Trial Overview The study is testing 'Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH)', which is a faith-based intervention aimed at reducing depression symptoms. It's designed specifically for African Americans and could become the first evidence-based program of its kind if successful.

How Is the Trial Designed?

Group I: CB-FAITH treatment Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) is already approved in United States for the following indications:

Approved in United States as CB-FAITH for:

• Depression among African American adults

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

In a study of 94 hospitalized older patients with depression, 54% achieved remission within a median time of 30 weeks, highlighting the potential for recovery in this population.

Higher levels of intrinsic religiosity were found to significantly predict faster remission from depression, suggesting that personal religious beliefs may play a beneficial role in recovery, while church attendance and private religious activities did not show the same effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Religiosity and remission of depression in medically ill older patients. Koenig, HG., George, LK., Peterson, BL.[2019]

In a study of 1000 older medical inpatients with heart failure and/or chronic pulmonary disease, those who participated in group-related religious activities experienced a significantly shorter time to remission from depression.

Specifically, a combination of frequent religious attendance, prayer, Bible study, and high intrinsic religiosity was associated with a 53% increase in the speed of remission, indicating that community religious involvement may play a beneficial role in recovery from depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Religion and remission of depression in medical inpatients with heart failure/pulmonary disease. Koenig, HG.[2019]

PsycINFO was identified as the most effective database for finding studies on faith-sensitive interventions for treating depression, outperforming others in all priority categories.

In addition to major databases like MEDLINE and EMBASE, including social science and grey literature databases, as well as citation tracking, significantly enhances the retrieval of relevant studies, highlighting the importance of a comprehensive search strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Searching for religion and mental health studies required health, social science, and grey literature databases. Wright, JM., Cottrell, DJ., Mir, G.[2022]

A pilot project focused on homebound older adults indicated that an educational intervention by faith community nurses (FCNs) based on the CREATION Health Model may help reduce depression levels, as shown by a downward trend in Geriatric Depression Scale scores.

This suggests that integrating health education and support from FCNs could be a beneficial approach to addressing depression in older adults who are homebound.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacting Depression in Homebound Elderly: A CREATION Health Intervention for Faith Community Nurses. Parson, LJ.[2019]

Training faith community nurses (FCNs) in cognitive-behavioral and spiritual counseling (CBSC) significantly increased their comfort and perceived efficacy in providing counseling to rural dementia caregivers, as shown by pre-post evaluation results.

Case studies indicated that CBSC led to substantial improvements in caregiving challenges and reductions in depression among caregivers, suggesting that this approach may be effective, although further research is needed to confirm these findings across a larger sample.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative cognitive-behavioral and spiritual counseling for rural dementia caregivers with depression. Glueckauf, RL., Davis, WS., Allen, K., et al.[2018]

The study found that screening for depression using the Patient Health Questionnaire-9 (PHQ-9) in African-American churches is feasible, with a high prevalence of positive screens at 19.7%, particularly among men (22.5%).

This suggests that faith-based settings could play a crucial role in identifying and addressing depression in underserved populations, highlighting the need for targeted mental health interventions in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for Depression in African-American Churches. Hankerson, SH., Lee, YA., Brawley, DK., et al.[2022]

In a study involving 132 participants with major depression and chronic medical illness, both conventional cognitive behavioral therapy (CCBT) and religiously integrated CBT (RCBT) showed similar efficacy after 12 weeks, indicating that both approaches can effectively treat depression.

However, adherence to RCBT was slightly higher among more religious participants, suggesting that individual religiosity may influence treatment engagement and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Religious vs. conventional cognitive behavioral therapy for major depression in persons with chronic medical illness: a pilot randomized trial. Koenig, HG., Pearce, MJ., Nelson, B., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06292637/cognitive-behavioral-and-faith-fellowship-to-improve-thy-health

Cognitive Behavioral and Faith Fellowship to Improve Thy ... Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American ...

2. withpower.com withpower.com/trial/phase-depression-3-2024-a4a3d

Faith-Based Program for Depression (CB-FAITH Trial) CB-FAITH is unique because it combines cognitive-behavioral therapy (a type of talk therapy) with faith-based elements, which may include religious activities ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10418714/

Faith-Based Spiritual Intervention for Persons with ... The preliminary evidence suggested that the faith-based spiritual intervention was effective in reducing depressive symptoms.

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2802550

Clinical Effectiveness and Cost-Effectiveness of Supported ... Practitioner-supported MBCT-SH for mild to moderate depression was clinically effective and cost-effective compared with currently recommended practitioner- ...

5. digitalcommons.liberty.edu digitalcommons.liberty.edu/cgi/viewcontent.cgi?article=3034&context=doctoral

effectiveness of religious cognitive behavior therapy for the The usefulness of RCBT for depressed counselees in a Christian clinic or church depends on the demonstrated results of CBT and RCBT in mental health literature.

6. paxrenewalcenter.com paxrenewalcenter.com/faith-based-cognitive-behavioral-therapy/

Faith Based Cognitive Behavioral Therapy: Powerful 2025 Explore faith based cognitive behavioral therapy. Integrate faith & science to overcome anxiety, depression, and find lasting healing.

7. youtube.com youtube.com/watch?v=XRJHy49NiWI

Religiously-Integrated Cognitive Behavioral Therapy for ... SUMMARY: This seminar will explain religiously-integrated cognitive behavioral therapy (RCBT) and why it is an important treatment approach ...