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

NCT03360136 | Completed

• 1 other identifier: 2016/1834- 31/2
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Exhaustion Disorder; Burnout; Clinical Burnout

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (14)

• Change from baseline in Quality of life

  Week 24

• Change from baseline to follow-up in Quality of life

  Week 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

Other Outcomes (2)

• Negative Effects of psychotherapy

  at 24 week only

• Treatment credibility rating

  Baseline and at 12 weeks

Study Arms (1)

Multi-professional CBT-rehabilitation

OTHER

24 weeks CBT-based multi-professional rehabilitation.

Behavioral: Multi-professional CBT-rehabilitation

Interventions

Multi-professional CBT-rehabilitation BEHAVIORAL

See "Detailed description"

Multi-professional CBT-rehabilitation

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Confirmed exhaustion disorder according to criteria established by the Swedish National Board of Health and Welfare
• years of age
• Considered suitable for multimodal rehabilitation in group
• Self-rating of \> 4,5 på SMBQ

You may not qualify if:

• Abuse of alcohol or drugs
• Moderate-high suicidal risk
• Severe psychiatric illness (severe depression, bipolar, schizophrenia etc.)
• Untreated PTSD

Sponsors & Collaborators

• Uppsala University: lead
• PBM Sweden AB: collaborator

Study Sites (2)

PBM Sweden AB Globen

Stockholm, Södermanland County, 12177, Sweden

Location

PBM Sweden City

Stockholm, Uppland, 114 47, Sweden

Location

Related Publications (3)

• Martensson G, Johansson F, Buhrman M, Ahs F, Clason van de Leur J. A network analysis of exhaustion disorder symptoms throughout treatment. BMC Psychiatry. 2024 May 23;24(1):389. doi: 10.1186/s12888-024-05842-9.

  PMID: 38783205 DERIVED

• van de Leur JC, Buhrman M, Wallby K, Karlstrom A, Johansson F. Associations between improvements in psychological variables and subsequent sick leave among persons receiving a multimodal intervention for exhaustion disorder. BMC Public Health. 2023 Oct 11;23(1):1976. doi: 10.1186/s12889-023-16799-x.

  PMID: 37821913 DERIVED

• 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.

  PMID: 33153461 DERIVED

MeSH Terms

Conditions

Syndrome; Burnout, Professional; Burnout, Psychological; Adjustment Disorders

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Occupational Stress; Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Gunilla Brodda Jansen, Assoc. Proff.

  Karolinska University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Clinical Trial

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 2, 2017
• Study Start: October 1, 2017
• Primary Completion: December 29, 2020
• Study Completion: December 29, 2020
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

SE (2)