Bourse cognitivo-comportementale et religieuse pour améliorer votre santé (CB-FAITH)
Bourse cognitivo-comportementale et religieuse pour améliorer votre santé (CB-FAITH) - Une étude de faisabilité et d'acceptabilité
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Wisconsin
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Madison, Wisconsin, États-Unis, 53711-3800
- Second Baptist Church
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Madison, Wisconsin, États-Unis, 53715-1218
- The Board of Regents of the UW System
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Madison, Wisconsin, États-Unis, 53515
- University of Wisconsin - Madison
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Contrôler
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Expérimental: Traitement CB-FAITH
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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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient Health Questionnaire
Délai: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
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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
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Score on Quick Inventory of Depressive Symptomatology-clinician rated (QIDS-CR)
Délai: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
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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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Multidimensional Measure of Religious Involvement (MMRI) score
Délai: baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
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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. |
baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
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Client Satisfaction Inventory (CSI) score
Délai: approximately Week 13-16 (End of CB-FAITH classes)
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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)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Earlise Ward, PhD, University of Wisconsin, Madison
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2020-1484
- A545000 (Autre identifiant: UW Madison)
- NUR/FACULTY AFFAIRS/ADMIN (Autre identifiant: UW Madison)
- 1R01HS029477-01 (Subvention/contrat AHRQ des États-Unis)
- Protocol Version 9/5/2025 (Autre identifiant: UW Madison)
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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