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临床试验/NCT05811156
NCT05811156已完成不适用

A Biopsychosocial Treatment Model for Exhaustion Due to Persistent Non-traumatic Stress, Administered Through a Multimodal Digital Intervention - A Pilot Study

Uppsala University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
26
试验地点
1
主要终点
Karolinska Exhaustion Disorder Scale

研究概览

简要总结

Currently, there are no established theoretical models for developing and maintaining Exhaustion due to persistent non-traumatic stress (ENTS). Therefore, the current pilot study aims to evaluate a Multimodal hybrid intervention built around an internet-delivered cognitive behavioral therapy based on a new biopsychosocial treatment model of ENTS.

详细描述

Since 2009 long term sick-leave rates due to mental disorders have been increasing in Sweden and are today the leading cause of long-term sick leave. Exhaustion due to persistent non-traumatic stress (ENTS) accounts for most of this increase. Unfortunately, despite several published treatment studies, no evidence-based treatments exist for ENTS, and little is still known about the focus of treatment.

Currently, there are no established theoretical models for the development and maintenance of ENTS. Many of the published clinical ENTS trials consist of long (6 months or more) Multimodal interventions (MMI) containing various medical, psychological, and physiotherapeutic methods with a low degree of understanding of what components are critical for treatment success. Even if ENTS patients participating in MMI report symptom improvements and work resumption, MMI is generally personnel intensive and challenging to administer. These factors increase the risk of extended healthcare lead times and obstruct treatment dissemination.

Considering the increasing sick-leave rates due to ENTS, there is an apparent need for more accessible treatments based on pronounced theoretical models focusing on specific change processes. Therefore, the current pilot study aims to evaluate a hybrid MMI built around an internet-delivered cognitive behavioral therapy based on a new biopsychosocial treatment model of ENTS.

Outcome measures will be collected before and after treatment and at three and six-month follow-ups. Weekly measurements of putative processes of change will also be collected. The current study aims to evaluate whether this more restricted and theoretically coherent hybrid MMI shows promising results before we test the treatment solely as a cognitive behavioral therapy via the internet in a randomized controlled trial.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Referred for Stress-induced exhaustion disorder (SED)
  • •Fulfilled the criteria for SED
  • •Scored > 5 on the Shirom-Melamed Burnout Questionnaire (a cut-off determined by the Health Care Services Stockholm County)
  • •Scored 19 > on Karolinska Exhaustion Disorder Scale
  • •In need of sick-leave due to SED d) access to internet

排除标准

  • •100 % sick leave of more than one year
  • •abuse of alcohol or drugs
  • •participating in any other form of MMI
  • •severe depression, moderate/high risk of suicide, psychosis, or untreated PTSD.

结局指标

主要结局

Karolinska Exhaustion Disorder Scale

时间窗: Baseline measurement, weekly (up to 12 weeks) change during from treatment baseline to immediately after treatment, change between immediately after treatment and 3 months follow-up, change between 3 months follow up and 6 months follow-up

Measures symptoms of Exhaustion. It is specifically tailored to measure symptoms from the Swedish diagnosis of Stress-induced exhaustion disorder.

次要结局

  • The current percentage of working time and sick-leave(Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up)
  • Hospital Anxiety and Depression Scale (HADS)(Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up)
  • Flourishing scale(Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up)
  • Negative Effects Questionnaire(immediately after treatment)
  • Client satisfaction Questionnaire- 8(immediately after treatment)
  • WHO Disability Assessment Schedule 2.0-12 (Rated by independent rater)(Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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