An observational study in Exhaustion Disorder and Clinical Burnout, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Uppsala University · Observational
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.
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.
Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with SED who are accepted to treatment for a Multimodal digital intervention within a specialized healthcare initiative called "The healthcare choice for treatment of longstanding pain with or without comorbidity, and SED."
Exclusion Criteria:
Multimodal digital intervention, including an internet-delivered CBT treatment based on a biopsychosocial exposure treatment, tailored explicitly for Exhaustion due to persistent non-traumatic stress.
Also known as: Internet CBT
Karolinska Exhaustion Disorder Scale
Measures symptoms of Exhaustion. It is specifically tailored to measure symptoms from the Swedish diagnosis of Stress-induced exhaustion disorder.
Time frame: 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
Hospital Anxiety and Depression Scale (HADS)
Measure of depression and anxiety
Time frame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
Flourishing scale
brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism
Time frame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
The current percentage of working time and sick-leave
Rated by independent rater through telephone interview
Time frame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
WHO Disability Assessment Schedule 2.0-12 (Rated by independent rater)
Measures difficulties due to health conditions
Time frame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
Client satisfaction Questionnaire- 8
Measure of treatment satisfaction
Time frame: immediately after treatment
Negative Effects Questionnaire
Measures negative effects attributable to treatment
Time frame: immediately after treatment
Perfectionistic concerns, sub scale av Clinical Perfectionism Questionnaire
A measure of perfectionistic concerns, a putative process variable in treatment
Time frame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Penn-state worry questionnaire-brief
A measure of pathological worry, a putative process variable in treatment
Time frame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Psy-flex
A measure of psychological flexibility, a putative process variable in treatment
Time frame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Insomnia severity index (3-item version)
A measure of psychological dimensions of insomnia, a putative process variable in treatment
Time frame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Plan to share: No
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Uppsala University