Psychological Treatments for Scleroderma
Psychosocial Interventions for Scleroderma
연구 개요
상태
상세 설명
This study will examine the efficacy of psychological interventions designed to target important areas of daily living for people with scleroderma: pain, depression, and distress about disfigurement. The study will also examine the effect of clinical depression on impact of the psychological treatments. Because psychological interventions requiring a trained professional can be costly and are often not available to the majority of patients, the study will also examine the efficacy of a self-help intervention.
The study will recruit 201 patients with systemic sclerosis who report symptoms of pain, depression, or distress about disfigurement and will randomly assign them to one of three interventions: individual cognitive behavioral therapy, self-help cognitive behavioral intervention facilitated by a psychologist, or a disease/health education intervention. An individual blinded to intervention assignment will collect measures of pain, functioning, distress about disfigurement, and mood at baseline and following the 8-week intervention period.
Both the cognitive-behavioral self-help materials and the educational materials (eight written chapters and audiotapes) will be designed for home use but will be supplemented by two individual sessions and two telephone contacts with the professional. Patients will be followed for 1 year after completing the active intervention phase.
These findings will increase understanding of the quality of life of individuals with scleroderma and determine whether self-help interventions can be used effectively to manage pain, depression, and distress about disfigurement.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21224
- Johns Hopkins Bayview Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Diagnosis of CREST or systemic sclerosis
- Short-Form McGill Pain Questionnaire score 6 or higher
- Satisfaction with Appearance score of 15 or higher
- Beck Depression score of 10 or higher
Exclusion Criteria:
- Patients reporting severe depression with suicidal ideation
- Delirium, dementia, or cognitive impairment (Mini Mental State Examination (MMSE) < 24))
- Terminal illness with a life expectancy of less than 1 year
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: 1
Participants will receive individual cognitive behavioral therapy
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실험적: 2
Participants will receive self-help cognitive behavioral intervention facilitated by a psychologist
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활성 비교기: 3
Participants will receive a disease/health education intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Depressive symptoms
기간: Measured at Week 8
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Measured at Week 8
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Body image dissatisfaction
기간: Measured at Week 8
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Measured at Week 8
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Pain
기간: Measured at Week 8
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Measured at Week 8
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jennifer A. Haythornthwaite, Johns Hopkins University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
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. .
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