Open Clinical Trial of CBT-based Multiprofessional Rehabilitation for Exhaustion Disorder

Study Overview
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Brief Summary
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Stress-related mental disorders are today the leading cause of long-term sick leave in Sweden, and a large part of this increase is due to Clinical burnout, in Sweden called Exhaustion disorder (ED). Even though clinical guidelines recommend multi-professional rehabilitation (MPR) for ED, few studies have evaluated the effects of these treatment programs in clinical practice. This large-scale open clinical trial investigates whether MPR for ED seems to alleviate symptoms of ED and if it results in return-to-work.

Detailed Description
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This study is carried out at two specialized stress rehabilitation centers in Stockholm. All patients included in the clinics stress rehabilitation program are asked to participate in the study and are recruited consecutively from October 2017 throughout December 2018. An estimate of 400 patients will be included. The treatment program is a 24-week Multiprofessional standardized CBT-rehabilitation consisting of a nine-session CBT group treatment (stress management) followed by a seven-session group treatment in applied relaxation. Parallel to the group treatments patients receives nine sessions of individual CBT, three visits to an MD (for medication, follow-up, and sick-listing), two individual sessions to a physiotherapist and a three session-exercise group. Also, vocational measures are taken through rehabilitation meetings together with the patient's employer (if an employer exists). Primary treatment outcomes will be return-to-work (RTW) and symptoms of ED, anxiety, and depression. Secondary treatment outcomes will be quality of life, pathological worry, psychological flexibility, clinical perfectionism, insomnia, burnout, and symptoms. Predictors of symptom development and RTW will be explored. Also, comorbidity of chronic pain, negative effects of psychotherapy and treatment credibility will be investigated.

Official Title
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Multiprofessional Rehabilitation for Exhaustion Disorder

Conditions
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Exhaustion; Syndrome, Burnout, Professional, Burnout Syndrome, Adjustment Disorders

Intervention / Treatment
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* Behavioral: Multi-professional CBT-rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed exhaustion disorder according to criteria established by the Swedish National Board of Health and Welfare 18 - 64 years of age Considered suitable for multimodal rehabilitation in group Self-rating of > 4,5 på SMBQ Exclusion Criteria: Abuse of alcohol or drugs Moderate-high suicidal risk Severe psychiatric illness (severe depression, bipolar, schizophrenia etc.) Untreated PTSD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open Clinical Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multi-professional CBT-rehabilitation<br>24 weeks CBT-based multi-professional rehabilitation. | Behavioral: Multi-professional CBT-rehabilitation<br>* See Detailed description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in exhaustion symptoms | Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items | Week 12 and 24 | 
| Change from baseline to follow-up in exhaustion symptoms | Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items | Week 12, 24 and 76 | 
| Change from baseline in depression | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12 and 24 | 
| Change from baseline to follow-up in depression | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12, 24 and 76 | 
| Change from baseline in anxiety | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12 and 24 | 
| Change from baseline to follow-up in anxiety | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12, 24 and 76 | 
| Change from baseline in employment rate | Sick-leave data collected from the Swedish Social Insurance Agency | Week 24 | 
| Change from baseline to follow-up in employment rate | Sick-leave data collected from the Swedish Social Insurance Agency | Week 24 and 76 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Quality of life | Self-reported change in EQ5D, 5 items | Week 24 | 
| Change from baseline to follow-up in Quality of life | Self-reported change in EQ5D, 5 items | Week 24 and 76 | 
| Change from baseline in insomnia symptoms | Self-reported change in Insomnia Severity Index (ISI), 7 items | Week 12 and 24 | 
| Change from baseline to follow-up in insomnia symptoms | Self-reported change in Insomnia Severity Index (ISI), 7 items | Week 12, 24 and 76 | 
| Change from baseline in Clinical Perfectionism | Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items | Week 12 and 24 | 
| Change from baseline to follow-up in Clinical Perfectionism | Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items | Week 12, 24 and 76 | 
| Change from baseline in Psychological Flexibility | Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items | Week 12 and 24 | 
| Change from baseline to follow-up in Psychological Flexibility | Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items | Week 12, 24 and 76 | 
| Change from baseline in pathological worry | Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items | Week 12 and 24 | 
| Change from baseline to follow-up in pathological worry | Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items | Week 12, 24 and 76 | 
| Change from baseline in perceived work ability | Self-rated work ability, 1 single item from Work Ability index (WAI) | Week 12 and 24 | 
| Change from baseline to follow up in perceived work ability | Self-rated work ability, 1 single item from Work Ability index (WAI) | Week 12, 24 and 76 | 
| Change from baseline in burnout | Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items | Week 12 and 24 | 
| Change from baseline to follow-up in burnout | Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items | Week 12, 24 and 76 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exhaustion Disorder, Burnout, Clinical Burnout