- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07588724
Effectiveness of Cognitive Behavioral Therapy on Psychological Distress and Problem-Solving Skills in Women With Vaginismus (CBT-VAG)
Effectiveness of Cognitive Behavioral Therapy on Psychological Distress and Problem-Solving Skills in Women With Vaginismus: A Randomized Controlled Trial
연구 개요
상세 설명
Vaginismus is associated with considerable psychological distress, emotional difficulties, and impaired interpersonal relationships. Cognitive behavioral therapy (CBT) has demonstrated effectiveness in reducing anxiety, maladaptive cognitions, and emotional distress in various psychological and sexual disorders. However, limited evidence is available regarding the effectiveness of CBT interventions among women with vaginismus in Arab populations.
This study used a randomized controlled trial design to evaluate the effectiveness of a structured CBT intervention program on psychological distress and problem-solving skills among women with vaginismus attending outpatient obstetrics and gynecology clinics in Port Said Governorate, Egypt. Participants were randomly allocated into an intervention group and a control group.
The intervention program consisted of structured CBT sessions integrating cognitive restructuring, relaxation techniques, adaptive coping strategies, and problem-solving training. The intervention was delivered over three months through structured sessions lasting approximately 60-90 minutes.
Primary outcomes included psychological distress measured using the Depression Anxiety Stress Scale (DASS-21). Secondary outcomes included problem-solving skills measured using the Problem-Solving Inventory (PSI). Baseline and post-intervention assessments were conducted to evaluate the effectiveness of the intervention.
The study aimed to provide evidence regarding the effectiveness and cultural applicability of CBT interventions for women with vaginismus within Arab healthcare settings.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Port Said, 이집트
- Dar Sehet Elmaraa Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Women diagnosed with vaginismus.
- Age between 20 and 50 years.
- Ability to communicate and participate in the intervention sessions.
- Willingness to participate and provide written informed consent.
Exclusion Criteria:
- Presence of severe psychiatric disorders or cognitive impairment.
- Current participation in another psychological intervention program.
- Presence of severe medical conditions that may interfere with participation in the study.
- Refusal to participate or inability to complete the intervention 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 Behavioral Therapy Group
Participants in this group received a structured cognitive behavioral therapy (CBT) intervention program integrating cognitive restructuring, relaxation techniques, adaptive coping strategies, and problem-solving training.
The intervention was delivered through structured sessions over a three-month period.
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The intervention consisted of a structured cognitive behavioral therapy (CBT) program designed for women with vaginismus.
The program integrated cognitive restructuring, relaxation techniques, adaptive coping strategies, and problem-solving training.
Sessions were delivered over a three-month period through structured interactive sessions lasting approximately 60-90 minutes.
다른 이름들:
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간섭 없음: Control Group
Participants in this group received routine care and attended non-therapeutic discussion sessions without receiving the structured cognitive behavioral therapy intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Psychological Distress
기간: Baseline and 3 months post-intervention
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Psychological distress was measured using the Depression Anxiety Stress Scale-21 (DASS-21).
Total scores range from 0 to 63, with higher scores indicating greater psychological distress and worse psychological outcomes among women with vaginismus.
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Baseline and 3 months post-intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Problem-Solving Skills
기간: Baseline and 3 months post-intervention
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Problem-solving skills were measured using the Problem-Solving Inventory (PSI). Total scores range from 32 to 192, with higher scores indicating poorer perceived problem-solving ability and lower scores indicating better problem-solving skills. Time |
Baseline and 3 months post-intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Basma W Elrefay, PhD, Faculty of Nursing, Port Said University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- PSU-CBT-VAG-2024-01
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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