Faith-Based Program for Depression

(CB-FAITH Trial)

Recruiting at 1 trial location

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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) for depression?

Research shows that religious involvement, such as attending group activities and prayer, can help people recover from depression faster. Additionally, religiously integrated cognitive behavioral therapy (CBT) may be slightly more effective for people who are more religious. ^{1 2 3 4 5}

How is the CB-FAITH treatment for depression different from other treatments?

CB-FAITH is unique because it combines cognitive-behavioral therapy (a type of talk therapy) with faith-based elements, which may include religious activities like prayer and Bible study, to help improve mental health. This approach is particularly beneficial for individuals who are religious, as it integrates their faith into the therapeutic process, potentially leading to faster remission of depression. ^{1 2 3 6 7}

Research Team

Earlise Ward, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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 suicidal ideations (trained staff will conduct a suicide risk assessment and facilitate referral for appropriate care)

Current participation in psychotherapy

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Searching for religion and mental health studies required health, social science, and grey literature databases. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Religiosity and remission of depression in medically ill older patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Religious vs. conventional cognitive behavioral therapy for major depression in persons with chronic medical illness: a pilot randomized trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Integrative cognitive-behavioral and spiritual counseling for rural dementia caregivers with depression. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Screening for Depression in African-American Churches. [2022]