Clinical trial NCT03360136: Open Clinical Trial of CBT-based Multiprofessional Rehabilitation for Exhaustion Disorder
Official title: Multiprofessional Rehabilitation for Exhaustion Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exhaustion; Syndrome
Burnout, Professional
Burnout Syndrome
Adjustment Disorders
Keywords: Exhaustion Disorder
Burnout
Clinical Burnout
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: PBM Sweden AB
First posted: 2017-12-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Clinical Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline in exhaustion symptoms
timeFrame: Week 12 and 24
measure: Change from baseline to follow-up in exhaustion symptoms
timeFrame: Week 12, 24 and 76
measure: Change from baseline in depression
timeFrame: Week 12 and 24
measure: Change from baseline to follow-up in depression
timeFrame: Week 12, 24 and 76
measure: Change from baseline in anxiety
timeFrame: Week 12 and 24
measure: Change from baseline to follow-up in anxiety
timeFrame: Week 12, 24 and 76
measure: Change from baseline in employment rate
timeFrame: Week 24
measure: Change from baseline to follow-up in employment rate
timeFrame: Week 24 and 76
Secondary outcomes:
measure: Change from baseline in Quality of life
timeFrame: Week 24
measure: Change from baseline to follow-up in Quality of life
timeFrame: Week 24 and 76
measure: Change from baseline in insomnia symptoms
timeFrame: Week 12 and 24
measure: Change from baseline to follow-up in insomnia symptoms
timeFrame: Week 12, 24 and 76
measure: Change from baseline in Clinical Perfectionism
timeFrame: Week 12 and 24
measure: Change from baseline to follow-up in Clinical Perfectionism
timeFrame: Week 12, 24 and 76
measure: Change from baseline in Psychological Flexibility
timeFrame: Week 12 and 24
measure: Change from baseline to follow-up in Psychological Flexibility
timeFrame: Week 12, 24 and 76
measure: Change from baseline in pathological worry
timeFrame: Week 12 and 24
measure: Change from baseline to follow-up in pathological worry
timeFrame: Week 12, 24 and 76
measure: Change from baseline in perceived work ability
timeFrame: Week 12 and 24
measure: Change from baseline to follow up in perceived work ability
timeFrame: Week 12, 24 and 76
measure: Change from baseline in burnout
timeFrame: Week 12 and 24
measure: Change from baseline to follow-up in burnout
timeFrame: Week 12, 24 and 76
Other outcomes:
measure: Negative Effects of psychotherapy
timeFrame: at 24 week only
measure: Treatment credibility rating
timeFrame: Baseline and at 12 weeks
Locations:
city: Stockholm
country: Sweden
facility: PBM Sweden AB Globen
state: Södermanland
city: Stockholm
country: Sweden
facility: PBM Sweden City
state: Uppland
Study officials:
affiliation: Karolinska University
name: Gunilla Brodda Jansen, Assoc. Proff.
role: STUDY_CHAIR
References:
citation: van de Leur JC, Buhrman M, Ahs F, Rozental A, Jansen GB. Standardized multimodal intervention for stress-induced exhaustion disorder: an open trial in a clinical setting. BMC Psychiatry. 2020 Nov 5;20(1):526. doi: 10.1186/s12888-020-02907-3.