Comparative Efficacy of Cognitive Behavioral and Mindfulness Therapies in Reducing Post-Traumatic Stress Disorder Among Interpersonal Violence Survivors (COMPASS)
"Comparative Efficacy of Cognitive Behavioral and Mindfulness Therapies in Reducing Post-Traumatic Stress Disorder Among Interpersonal Violence Survivors"
調査の概要
状態
詳細な説明
Interpersonal/domestic violence is a major public health concern that is associated with a high prevalence of post-traumatic stress disorder (PTSD) and other adverse mental health outcomes. Although Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Therapy (MBT) have each demonstrated effectiveness in reducing PTSD symptoms, few randomized controlled trials have directly compared their relative efficacy among survivors of interpersonal violence, particularly in low- and middle-income settings. This study addresses this evidence gap by evaluating and comparing CBT and MBT using a randomized controlled trial design.
This is a parallel-group randomized controlled trial with three study arms: (1) Cognitive Behavioral Therapy (CBT), (2) Mindfulness-Based Therapy (MBT), and (3) psychoeducation as an active control. Approximately 60 adult survivors of interpersonal/domestic violence who meet DSM-5 criteria for PTSD following screening and diagnostic assessment will be randomly assigned in equal numbers to one of the three intervention groups. Participants will complete baseline, post-intervention, and follow-up assessments.
The primary objective is to compare the effectiveness of CBT, MBT, and psychoeducation in reducing PTSD symptom severity. Secondary objectives include evaluating changes in emotion regulation, mindfulness, perceived stress, and other related psychological outcomes following the interventions. The study hypothesizes that both CBT and MBT will produce greater reductions in PTSD symptoms than psychoeducation, while also examining whether one active intervention demonstrates superior effectiveness for specific PTSD symptom domains and psychological outcomes.
The findings will contribute to the evidence base for trauma-informed psychological interventions and may inform clinical practice by identifying effective, culturally relevant treatment approaches for survivors of interpersonal/domestic violence.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Punjab Province
-
Gujranwala、Punjab Province、パキスタン、52250
- Shelter Homes
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Female adults aged 18 years or older. History of interpersonal or domestic violence. Meets DSM-5 diagnostic criteria for post-traumatic stress disorder (PTSD), confirmed using the Structured Clinical Interview for DSM-5 (SCID-5).
Meets the eligibility threshold for PTSD symptoms on the PTSD Checklist for DSM-5 (PCL-5).
Able and willing to provide written informed consent. Willing to participate in all intervention sessions and study assessments.
Exclusion Criteria:
Current psychotic disorder or severe cognitive impairment. Active suicidal ideation or psychiatric emergency requiring immediate treatment.
Current substance use disorder that would interfere with participation. Currently receiving another structured trauma-focused psychological intervention.
Medical or psychiatric conditions that would prevent safe participation or completion of the study.
Unable to provide informed consent or comply with study procedures.
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 |
|---|---|
|
実験的：Cognitive Behavioral Therapy (CBT)
Cognitive Behavioral Therapy (CBT), a structured psychological intervention for post-traumatic stress disorder (PTSD) following interpersonal/domestic violence.
The intervention aims to reduce PTSD symptoms through psychoeducation, cognitive restructuring, behavioral techniques, coping skills training, and relapse prevention.
Participants will complete assessments at baseline, post-intervention, and follow-up.
|
Cognitive Behavioral Therapy (CBT) is a structured, trauma-informed psychological intervention designed to reduce post-traumatic stress disorder (PTSD) symptoms among adult survivors of interpersonal/domestic violence.
The intervention includes psychoeducation, cognitive restructuring, behavioral activation, coping skills training, trauma-focused cognitive and behavioral techniques, and relapse prevention.
他の名前：
|
|
実験的：Mindfulness-Based Therapy (MBT)
Participants assigned to this arm will receive Mindfulness-Based Therapy (MBT), a structured psychological intervention designed to reduce PTSD symptoms through mindfulness meditation, breathing exercises, body awareness, acceptance, and emotion regulation practices.
Participants will complete assessments at baseline, post-intervention, and follow-up.
|
Mindfulness-Based Therapy (MBT) is a structured psychological intervention that incorporates mindfulness meditation, breathing exercises, body awareness, acceptance, present-moment awareness, and emotion regulation strategies to reduce PTSD symptoms and improve psychological well-being among adult survivors of interpersonal/domestic violence.
他の名前：
|
|
アクティブコンパレータ：Psychoeducation
Participants assigned to this arm will receive a structured psychoeducation program providing information about trauma, post-traumatic stress disorder (PTSD), common trauma responses, coping strategies, stress management, safety planning, and available support services.
This intervention serves as the active comparison group.
Participants will complete assessments at baseline, post-intervention, and follow-up.
|
Psychoeducation is a structured behavioral intervention that provides information about trauma, PTSD symptoms, common psychological responses to interpersonal/domestic violence, coping strategies, stress management, safety planning, and available support resources.
It serves as the active comparator and does not include the therapeutic components of CBT or MBT
|
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 |
|---|---|---|
|
Change in Post-Traumatic Stress Disorder (PTSD) Symptom Severity
時間枠：Baseline, immediately post-intervention, and 3-month follow-up
|
Change in PTSD symptom severity will be assessed using the PTSD Checklist for DSM-5 (PCL-5).
The PCL-5 is a validated 20-item self-report questionnaire measuring PTSD symptoms, with higher scores indicating greater symptom severity.
The primary analysis will compare changes in PCL-5 scores among the Cognitive Behavioral Therapy (CBT), Mindfulness-Based Therapy (MBT), and Psychoeducation groups.
|
Baseline, immediately post-intervention, and 3-month follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Emotion Regulation
時間枠：Baseline, immediately post-intervention, and 3-month follow-up
|
Emotion regulation will be assessed using the Emotion Regulation Questionnaire (ERQ).
Changes in participants' emotion regulation abilities will be compared across the three intervention groups.
|
Baseline, immediately post-intervention, and 3-month follow-up
|
|
Change in Mindfulness
時間枠：Baseline, immediately post-intervention, and 3-month follow-up
|
Mindfulness will be assessed using the Mindful Attention Awareness Scale (MAAS).
Changes in mindfulness levels will be compared among the intervention groups.
|
Baseline, immediately post-intervention, and 3-month follow-up
|
|
Change in Perceived Stress
時間枠：Baseline, immediately post-intervention, and 3-month follow-up
|
Perceived stress will be assessed using the Perceived Stress Scale (PSS).
Changes in perceived stress will be compared across the three intervention groups.
|
Baseline, immediately post-intervention, and 3-month follow-up
|
協力者と研究者
スポンサー
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
追加の関連 MeSH 用語
その他の研究ID番号
- GIFT/PSY/MS/2025/017
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?
IPD プランの説明
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。