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Clinical Trials/NCT03360136
NCT03360136
Completed
Not Applicable

Multiprofessional Rehabilitation for Exhaustion Disorder

Uppsala University2 sites in 1 country1,000 target enrollmentOctober 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exhaustion; Syndrome
Sponsor
Uppsala University
Enrollment
1000
Locations
2
Primary Endpoint
Change from baseline in exhaustion symptoms
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2017
End Date
December 29, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change from baseline in exhaustion symptoms

Time Frame: Week 12 and 24

Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items

Change from baseline in depression

Time Frame: Week 12 and 24

Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items

Change from baseline to follow-up in depression

Time Frame: Week 12, 24 and 76

Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items

Change from baseline in employment rate

Time Frame: Week 24

Sick-leave data collected from the Swedish Social Insurance Agency

Change from baseline to follow-up in employment rate

Time Frame: Week 24 and 76

Sick-leave data collected from the Swedish Social Insurance Agency

Change from baseline in anxiety

Time Frame: Week 12 and 24

Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items

Change from baseline to follow-up in anxiety

Time Frame: Week 12, 24 and 76

Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items

Change from baseline to follow-up in exhaustion symptoms

Time Frame: Week 12, 24 and 76

Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items

Secondary Outcomes

  • Change from baseline to follow-up in pathological worry(Week 12, 24 and 76)
  • Change from baseline to follow up in perceived work ability(Week 12, 24 and 76)
  • Change from baseline to follow-up in Quality of life(Week 24 and 76)
  • Change from baseline in burnout(Week 12 and 24)
  • Change from baseline in Psychological Flexibility(Week 12 and 24)
  • Change from baseline to follow-up in burnout(Week 12, 24 and 76)
  • Change from baseline in insomnia symptoms(Week 12 and 24)
  • Change from baseline to follow-up in insomnia symptoms(Week 12, 24 and 76)
  • Change from baseline in Clinical Perfectionism(Week 12 and 24)
  • Change from baseline in pathological worry(Week 12 and 24)
  • Change from baseline in Quality of life(Week 24)
  • Change from baseline to follow-up in Psychological Flexibility(Week 12, 24 and 76)
  • Change from baseline in perceived work ability(Week 12 and 24)
  • Change from baseline to follow-up in Clinical Perfectionism(Week 12, 24 and 76)

Study Sites (2)

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