Mind-Body Interventions in Coronary Artery Disease (MBI-CAD)
Effects of Combined Mind-Body Interventions in Patients With Coronary Artery Disease
This randomized controlled study aims to evaluate the effects of a combined mind-body intervention consisting of progressive muscle relaxation and guided imagery on psychological outcomes in patients with stable coronary artery disease.
A total of 40 participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive eight individualized sessions over four weeks in addition to standard medical care, while the control group will continue with standard care only.
Primary and secondary outcomes will be assessed using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory, administered at baseline and after the intervention period.
The main objective of the study is to determine whether structured mind-body techniques can reduce perceived stress, anxiety, and depressive symptoms and improve coping strategies in patients with coronary artery disease.
연구 개요
상세 설명
This study is a prospective, randomized controlled clinical trial designed to evaluate the effects of a structured mind-body intervention on psychological outcomes in patients with stable coronary artery disease.
Eligible participants will be recruited from Ufuk University Department of Cardiology and randomly assigned to either an intervention group or a control group using a simple randomization method. The intervention group will receive eight individualized sessions of progressive muscle relaxation and guided imagery over a four-week period in addition to standard medical care. Each session will last approximately 45-60 minutes and will be conducted in a controlled clinical environment by trained researchers. The control group will continue receiving standard medical care without any additional psychological or behavioral intervention.
Outcomes will be assessed at baseline and post-intervention using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory. The primary outcome is change in perceived stress levels. Secondary outcomes include changes in anxiety, depression, and coping strategies.
Data will be analyzed using repeated measures ANOVA to examine the interaction effects between group (intervention vs control) and time (baseline vs post-intervention). Effect sizes will be reported, and statistical significance will be set at p < 0.05.
The study does not involve any investigational drugs, biologics, or medical devices, and poses minimal risk to participants.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ankara
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Ankara, Ankara, 터키 (Türkiye), 06000
- Ufuk University Faculty of Medicine, Department of Cardiology
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Diagnosed with stable coronary artery disease
- Aged between 18 and 65 years
- Able to read and understand Turkish
- Able to complete study questionnaires and assessments
- Willing to provide written informed consent
Exclusion Criteria:
- History of acute coronary syndrome within the last 3 months
- Presence of a diagnosed severe psychiatric disorder
- Cognitive impairment or communication difficulties that may interfere with study participation
- Previous regular participation in mind-body interventions such as progressive muscle relaxation, guided imagery, meditation, or similar programs
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention Group
Participants in this arm will receive an eight-session individualized mind-body intervention consisting of progressive muscle relaxation and guided imagery in addition to standard medical care.
Sessions will be delivered twice weekly over four weeks in a clinical setting by trained researchers.
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A structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.
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간섭 없음: Control Group
Participants in this arm will receive standard medical care only without any additional psychological or behavioral intervention.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Perceived Stress Scale (PSS) Score
기간: Baseline and 4 weeks
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The primary outcome is the change in perceived stress levels measured by the Perceived Stress Scale (PSS) between baseline and the end of the 4-week intervention period.Scores range from 0 to 16, with higher scores indicating greater perceived stress.
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Baseline and 4 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score
기간: Baseline and 4 weeks
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Change in anxiety measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS).
Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.
Outcome will be assessed at baseline and 4 weeks.
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Baseline and 4 weeks
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Change in Hospital Anxiety and Depression Scale (HADS) Depression Score
기간: Baseline and 4 weeks
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Change in depression measured by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS).
Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.
Outcome will be assessed at baseline and 4 weeks.
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Baseline and 4 weeks
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Change in COPE Coping Strategies Scale Scores
기간: Baseline and 4 weeks
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Change in coping strategies measured by the COPE Inventory.
The instrument contains 15 coping subscales, each scored from 4 to 16, with higher scores indicating greater use of the respective coping strategy.
Outcomes will be assessed at baseline and 4 weeks.
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Baseline and 4 weeks
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Şeyda Candeniz, PhD, Ankara University
간행물 및 유용한 링크
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
- UFUK-SAGBIL-BADEK-2026/05
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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