A Biopsychosocial Treatment for Exhaustion Due to Persistent Non-traumatic Stress

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Exhaustion Disorder, Clinical Burnout

Intervention / Treatment
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* Behavioral: Hybrid Multimodal digital intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Hybrid Multimodal digital intervention|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karolinska Exhaustion Disorder Scale | Measures symptoms of Exhaustion. It is specifically tailored to measure symptoms from the Swedish diagnosis of Stress-induced exhaustion disorder. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) | Measure of depression and anxiety | 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 | 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 | 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 | 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 | immediately after treatment | 
| Negative Effects Questionnaire | Measures negative effects attributable to treatment | immediately after treatment |