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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Cara Herbitter, PhD, MPH
- 전화번호: 857-364-6528
- 이메일: Cara.Herbitter@va.gov
연구 장소
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Massachusetts
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Jamaica Plain, Massachusetts, 미국, 02130
- VA Boston Healthcare System
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연락하다:
- Cara Herbitter, PhD, MPH
- 전화번호: 857-364-6528
- 이메일: Cara.Herbitter@va.gov
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Post traumatic stress disorder symptoms (PTSD)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Cara Herbitter, PhD, MPH, Psychiatry CABUSM and National Center for PTSD, VA Boston Healthcare System
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- H-45022
- 1K23MH133986-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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