Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress
Cognitive Processing Therapy for Posttraumatic Stress Disorder and Co-occurring Lived Experience Stress: A Pilot Randomized Controlled Trial
Populations facing health disparities include groups with significantly higher rates of posttraumatic stress disorder than the general population who frequently experience lived experience stress, which may complicate posttraumatic stress disorder symptom presentations. However, there are currently no posttraumatic stress disorder treatments designed to meet the unique needs of these individuals.
The proposed study will pilot an adaptation of Cognitive Processing Therapy (a gold-standard treatment for posttraumatic stress disorder) that has been modified to incorporate the impact of lived experience stress as an additional treatment target. This project has the potential to advance our understanding of how to enhance Cognitive Processing Therapy in order to optimize posttraumatic stress disorder treatment response and mitigate health disparities.
調査の概要
詳細な説明
This study will occur in two phases.
Phase 1 will involve refining Cognitive Processing Therapy Lived Experience Adapted Protocol (CPT-LEAP) and includes beta testing of CPT-LEAP (n=6).
Phase 2 will involve a pilot RCT in which participants (n=52) will be randomized (1:1) to standard CPT or CPT-LEAP. The investigators anticipate 26 participants will be enrolled in each treatment arm.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Cara Herbitter, PhD, MPH
- 電話番号：857-364-6528
- メール：Cara.Herbitter@va.gov
研究場所
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Massachusetts
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Jamaica Plain、Massachusetts、アメリカ、02130
- VA Boston Healthcare System
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コンタクト：
- Cara Herbitter, PhD, MPH
- 電話番号：857-364-6528
- メール：Cara.Herbitter@va.gov
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-
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:
- Current diagnosis of PTSD
- Self-identification as a sexual or gender minority (SGM) individual
- Endorsement of SGM stress experiences with moderate distress
- For patients who take psychiatric medication, stable dose one month prior to enrollment
- Reside in Massachusetts.
Exclusion Criteria:
- Current active suicidal or homicidal ideation with intent or plan
- Unstable bipolar disorder/current mania
- Unstable psychotic disorder/current psychosis
- Current severe substance use that warrants immediate medical attention
- Cognitive impairment or organic disorder (e.g., advanced dementia, severe traumatic brain injury) that impairs ability to complete CPT procedures
- Past completion of CPT or current trauma-focused treatment
- Unwillingness to consent to audio or video recording of assessment and treatment sessions
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 |
|---|---|
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実験的：Cognitive Therapy Processing Therapy - Lived Experience Adapted Protocol (CPT--LEAP)
Participants randomized to this arm will receive the adapted CPT-LEAP treatment delivered in weekly one-hour sessions, using the CPT variable length format in line with standard VA practice (9-15 sessions).
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CPT-LEAP frames each session in relation to beliefs about both traumatic and lived experience stressors and their interactions and impacts, including not only beliefs about oneself, others, and the world, but also one's identity, and use of relevant examples throughout the protocol.
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アクティブコンパレータ：Standard Cognitive Therapy Processing (CPT)
Participants randomized to this arm will receive standard CPT treatment delivered in weekly one-hour sessions, using the CPT variable length format in line with standard VA practice (9-15 sessions).
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CPT focuses on teaching skills to identify and challenge PTSD-maintaining maladaptive beliefs related to the trauma itself, the world, and oneself.
Worksheets and assignments are given between each session.
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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 |
|---|---|---|
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Post traumatic stress disorder symptoms (PTSD)
時間枠：immediately after treatment, 3 months
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Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (CAPS-5).
The CAPS-5 includes 20 items assessing PTSD symptom severity.
Total scores range from 0-80 with higher scores indicating more severe PTSD symptoms.
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immediately after treatment, 3 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Cara Herbitter, PhD, MPH、Psychiatry CABUSM and National Center for PTSD, VA Boston Healthcare System
研究記録日
主要日程の研究
研究開始 (推定)
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
- H-45022
- 1K23MH133986-01A1 (米国 NIH グラント/契約)
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
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