- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07586358
Effect of Psychoeducation on Internalized Stigma and Anxiety in Patients Receiving Electroconvulsive Therapy (PE-ECT)
THE EFFECT OF PSYCHOEDUCATION PROGRAM APPLIED TO PATIENTS RECEIVING ELECTROCONVULSIVE THERAPY ON PATIENTS' INTERNALIZED STIGMA AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY
This randomized controlled clinical trial was conducted to evaluate the effect of a psychoeducational programme on internalised stigma and anxiety levels in patients undergoing electroconvulsive therapy (ECT). The study aimed to determine whether the psychoeducational intervention reduces internalised stigma related to mental illness and improves anxiety outcomes compared to routine nursing care.
The primary questions addressed were:
Does the psychoeducational programme reduce internalised stigma in patients receiving ECT? Does the intervention decrease state and trait anxiety levels compared to routine care? Researchers compared a psychoeducational intervention group with a control group receiving routine nursing care to assess the effects of the programme on psychological outcomes.
Participants in the intervention group:
Received a six-session psychoeducational programme delivered individually over six weeks Completed pre-test and post-test assessments using standardized measurement tools
Participants in the control group received routine psychiatric nursing care and completed the same assessment measures at equivalent time points.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Meram
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Konya, Meram, 터키 (Türkiye)
- Necmettin Erbakan University
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Age ≥ 18 years
- Able to read and write in Turkish
- At least primary school graduate
- Diagnosed according to DSM-5 criteria with schizophrenia or other psychotic disorders, bipolar disorder, major depressive disorder, obsessive-compulsive disorder, or generalized anxiety disorder
- Inpatients in a psychiatric clinic
- Receiving or scheduled to receive electroconvulsive therapy (ECT)
- No severe agitation or homicidal risk as determined by the treating psychiatrist
- Voluntary consent to participate in the study
Exclusion Criteria:
- Diagnosis of organic mental disorders (e.g., dementia, Alzheimer's disease, delirium)
- Intellectual disability
- History of alcohol or substance dependence
- Not completing at least 4 ECT sessions during the treatment process
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Psychoeducation Group (Arm 1)
Participants received a structured psychoeducational programme in addition to routine psychiatric care.
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A structured psychoeducational programme consisting of six individual face-to-face sessions delivered over six weeks by the researcher.
The programme aimed to reduce internalised stigma and anxiety in patients undergoing electroconvulsive therapy (ECT) and included education about illness, treatment process, coping strategies, and emotional support.
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활성 비교기: Routine Care Group (Arm 2)
Participants in this arm received routine psychiatric nursing care provided in the inpatient psychiatric clinic without any additional psychoeducational intervention.
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Standard psychiatric nursing care provided during electroconvulsive therapy (ECT) treatment.
No structured psychoeducational programme was applied.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Internalised Stigma Scale for Mental Illness (ISMI)
기간: Baseline and 6 weeks post-intervention
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Change in internalized stigma levels in patients undergoing electroconvulsive therapy (ECT), measured using the Internalized Stigma of Mental Illness Scale (ISMI).
Higher scores indicate higher levels of internalized stigma.
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Baseline and 6 weeks post-intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
State Anxiety Score (STAI-State)
기간: Baseline and 6 weeks post-intervention
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Change in state anxiety levels in patients undergoing electroconvulsive therapy (ECT), measured using the STAI-State subscale.
Higher scores indicate higher levels of current anxiety.
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Baseline and 6 weeks post-intervention
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Trait Anxiety Score (STAI-Trait)
기간: Baseline and 6 weeks post-intervention
|
Change in trait anxiety levels in patients undergoing electroconvulsive therapy (ECT), measured using the STAI-Trait subscale.
Higher scores indicate general anxiety tendency.
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Baseline and 6 weeks post-intervention
|
공동 작업자 및 조사자
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .