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Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial

2019년 12월 13일 업데이트: Erik Hedman, Karolinska Institutet
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. In the present study, we will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. Internet-based CBT can be described as online bibliotherapy with therapist support via a secure messaging system. In this study psychologists will deliver the treatment. We will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorder and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list. We expect that participants who receive ICBT will make superior improvements compared to the control condition on measures of stress, burnout, depressive symptoms, general anxiety and general functioning.

연구 유형

중재적

등록 (실제)

100

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

To be included in the study participants must be between 18 and 65 years of age and suffer from primary stress-related disorders by meeting diagnostic criteria for adjustment disorder or burnout syndrome. Participants must have access to a computer and to the Internet, as well as being able to write and write in Swedish.

Exclusion Criteria:

Exclusion criteria include (a) meeting the criteria for another axis-1 diagnosis that is assessed to be the primary area of difficulty, (b) suffering from substance abuse/dependence in the past 6 months, (c) suffering from current or past psychosis or bipolar disorder, (d) moderate to high suicide risk, (e) initiated or changed pharmachological treatment for depression or anxiety in the past month and (f) other on-going psychological treatment for stress-related difficulties, and (g) not having received CBT for stress-related ill-health in the past year.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Active treatment, Internet-based CBT
Internet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy. Participants will be stratified based on diagnosis, i.e. adjustment disorder and burnout.
행동: Internet-based CBT
Internet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy
간섭 없음: Waiting list control
The control condition is a waiting list. Participants in this arm receive no active treatment. After 12 weeks on waiting list, participants are crossed over to treatment.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Perceived stress scale (PSS)
기간: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in PSS at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up

2차 결과 측정

결과 측정
측정값 설명
기간
Shirlom Melamed Burnout Questionnaire (SMBQ)
기간: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in SMBQ at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Insomnia Severity Index (IS)
기간: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in ISI at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Generalized AnxietyDisorder-7 (GAD-7)
기간: baseline, post-treatment (12 weeks), 6 month follow-up
Change in GAD-7 at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Physical Health Questionnaire-15 (PHQ-15)
기간: baseline, post-treatment (12 weeks), 6 month follow-up
Change in PHQ-15 at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
기간: baseline, post-treatment (12 weeks), 6 month follow-up
Change in MADRS-S at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Self-rated health (SRH)
기간: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in SRH at post-treatment and follow-up compared to baseline
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Work Ability Index (WAI)
기간: baseline, post-treatment (12 weeks), 6 month follow-up
Change in WAI at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Euroqol 5 dimensions (EQ5D)
기간: baseline, post-treatment (12 weeks), 6 month follow-up
Change in EQ5D at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Brunnsviken Brief Quality of life inventory (BBQ)
기간: baseline, post-treatment (12 weeks), 6 month follow-up
Change in BBQ at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
World Health Organization Disability Assessment Schedule (WHODAS)
기간: baseline, post-treatment (12 weeks), 6 month follow-up
Change in WHODAS at post-treatment and follow-up compared to baseline.
baseline, post-treatment (12 weeks), 6 month follow-up
Alcohol Disorders Identification Test (AUDIT)
기간: Baseline
This instrument will be used for screening purpose only
Baseline
Sickness questionnaire state (SQ)
기간: baseline, post-treatment (12 weeks), 6 month follow-up
Change in SQ at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
기간: baseline, post-treatment (12 weeks), 6 month follow-up
Change in TIC-P at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Karolinska Sleep Questionnaire (KSQ)
기간: baseline, post-treatment (12 weeks), 6 month follow-up
Change in KSQ at post-treatment and follow-up compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up
Client Satisfaction Questionnaire (CSQ)
기간: Post-treatment (12 weeks)
Mean and standard deviations will be presented
Post-treatment (12 weeks)

기타 결과 측정

결과 측정
측정값 설명
기간
Credibility Scale (C-scale)
기간: Week 2 and week 8
Measures treatment credibility. Mean scores and standard deviations will be presented
Week 2 and week 8
Change in Putative mediators
기간: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Karolinska Institutet

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2015년 10월 1일

기본 완료 (실제)

2017년 10월 1일

연구 완료 (실제)

2017년 10월 1일

연구 등록 날짜

최초 제출

2015년 9월 1일

QC 기준을 충족하는 최초 제출

2015년 9월 2일

처음 게시됨 (추정)

2015년 9월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 12월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 12월 13일

마지막으로 확인됨

2019년 12월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ICBT for stress

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. .

소진 증후군에 대한 임상 시험

Internet-based CBT에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Ethiopia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다