あなたの健康を改善するための認知行動と信仰の交わり (CB-FAITH)
あなたの健康を改善するための認知行動と信仰のフェローシップ (CB-FAITH) - 実現可能性と受け入れ可能性の研究
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Wisconsin
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Madison、Wisconsin、アメリカ、53711-3800
- Second Baptist Church
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Madison、Wisconsin、アメリカ、53715-1218
- The Board of Regents of the UW System
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Madison、Wisconsin、アメリカ、53515
- University of Wisconsin - Madison
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：コントロール
|
|
|
実験的：CB-フェイス治療
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Health Questionnaire
時間枠：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. |
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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Multidimensional Measure of Religious Involvement (MMRI) score
時間枠：baseline, weeks 6 and 12 during the intervention, and follow up at 3 and 6 months
|
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
|
|
Client Satisfaction Inventory (CSI) score
時間枠：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)
|
協力者と研究者
捜査官
- 主任研究者：Earlise Ward, PhD、University of Wisconsin, Madison
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2020-1484
- A545000 (その他の識別子：UW Madison)
- NUR/FACULTY AFFAIRS/ADMIN (その他の識別子：UW Madison)
- 1R01HS029477-01 (米国 AHRQ グラント/契約)
- Protocol Version 9/5/2025 (その他の識別子：UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。