- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02535598
Therapy Labs: To Improve Adherence in Internet Based Psychotherapy
연구 개요
상태
정황
상세 설명
This study centers on people with mild symptoms of stress or worry. Participants are recruited by advertisement and the web. Potential participants are contacted by phone and informed about the study. Written informed consent is collected through mail from those who are interested in participating. They are asked to answer all the instruments of the study via a secure internet portal used for delivering the intervention. If they do not fulfill the exclusion criteria they are randomized to one of four conditions. When the intervention has ended participants are asked to fill out all the instruments and again at four week follow up. To find significant (p<.05) results on the primary outcome variables with estimated medium effect sizes, pair-wise comparisons, a power of .80 and allowing for 10% attrition, forty participants are needed in each condition.
The intervention used in this project will be a standard program of applied relaxation that has been used and empirically tested in previous clinical studies. Since the aim of the present project is to investigate factors that affect adherence rather than the intervention effect, the investigators will use a well tested intervention with known effects on symptoms of stress and anxiety. Previous studies have shown that self help with applied relaxation can have a positive effect on for example stress, anxiety and sleep. By providing an intervention that is beneficial, credible and relevant for people with mild symptoms of stress and anxiety it would be possible to investigate how manipulating different factors of the intervention affects the adherence. Applied relaxation will in this intervention consist of a four-week program provided via the Internet. The exact composition of the intervention will be slightly different in each condition depending on the research question, see below. The program includes four steps; tension sensitivity training, long relaxation, short relaxation and applied relaxation. Each week includes information, assignments and support via the secure internet portal.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Uppsala, 스웨덴, 75105
- Uppsala University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Self-reported mild to moderate symptoms of stress or worry
Exclusion Criteria:
- insufficient mastery of Swedish language
- elevated symptoms of anxiety or depression that warrant clinical care
- other medical or mental illness that need immediate clinical attention
- no daily access to computer, internet and cell phone
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Normal presentation
Standard internet based CBT presentation.
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All the material will be presented as plain text.
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실험적: Enhanced presentation
Enhanced internet CBT presentation.
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The material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc.
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활성 비교기: Normal support
Standard internet based CBT support.
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Participants receive semi-standardized support once a week and there will be no formal training or competence.
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실험적: Enhanced support
Enhanced internet CBT support.
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Participants are offered daily support through the internet from trained therapists.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Number of treatment components completed
기간: Four weeks after treatment start
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Four weeks after treatment start
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Number of behavioral prescriptions completed
기간: Four weeks after treatment start
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Four weeks after treatment start
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Perceived Stress Scale
기간: Baseline and four weeks after treatment start
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Baseline and four weeks after treatment start
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기타 결과 측정
결과 측정 |
기간 |
|---|---|
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Perceived Stress Scale
기간: Baseline and eight weeks after treatment start
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Baseline and eight weeks after treatment start
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공동 작업자 및 조사자
수사관
- 연구 책임자: Timo Hursti, PhD, Uppsala 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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- sveal1031
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. .