Skip to main content
OpenTrials
Completed

NCT Number: NCT03360136

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PBM Sweden AB Globen, Stockholm, Södermanland County, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-professional CBT-rehabilitation

Behavioral

See "Detailed description"

Primary outcomes

  1. Change from baseline in exhaustion symptoms

    Time frame: Week 12 and 24

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

  2. 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

  3. Change from baseline in depression

    Time frame: Week 12 and 24

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

  4. 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

  5. Change from baseline in anxiety

    Time frame: Week 12 and 24

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

  6. 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

  7. Change from baseline in employment rate

    Time frame: Week 24

    Sick-leave data collected from the Swedish Social Insurance Agency

  8. 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

Secondary outcomes

  1. Change from baseline in Quality of life

    Time frame: Week 24

    Self-reported change in EQ5D, 5 items

  2. Change from baseline to follow-up in Quality of life

    Time frame: Week 24 and 76

    Self-reported change in EQ5D, 5 items

  3. Change from baseline in insomnia symptoms

    Time frame: Week 12 and 24

    Self-reported change in Insomnia Severity Index (ISI), 7 items

  4. Change from baseline to follow-up in insomnia symptoms

    Time frame: Week 12, 24 and 76

    Self-reported change in Insomnia Severity Index (ISI), 7 items

  5. Change from baseline in Clinical Perfectionism

    Time frame: Week 12 and 24

    Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items

  6. Change from baseline to follow-up in Clinical Perfectionism

    Time frame: Week 12, 24 and 76

    Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items

  7. Change from baseline in Psychological Flexibility

    Time frame: Week 12 and 24

    Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items

  8. Change from baseline to follow-up in Psychological Flexibility

    Time frame: Week 12, 24 and 76

    Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items

  9. Change from baseline in pathological worry

    Time frame: Week 12 and 24

    Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items

  10. Change from baseline to follow-up in pathological worry

    Time frame: Week 12, 24 and 76

    Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items

  11. Change from baseline in perceived work ability

    Time frame: Week 12 and 24

    Self-rated work ability, 1 single item from Work Ability index (WAI)

  12. Change from baseline to follow up in perceived work ability

    Time frame: Week 12, 24 and 76

    Self-rated work ability, 1 single item from Work Ability index (WAI)

  13. Change from baseline in burnout

    Time frame: Week 12 and 24

    Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items

  14. Change from baseline to follow-up in burnout

    Time frame: Week 12, 24 and 76

    Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items

Other outcomes

  1. Negative Effects of psychotherapy

    Time frame: at 24 week only

    Self-Reported negative effects in Negative Effects Questionnaire, 32 items

  2. Treatment credibility rating

    Time frame: Baseline and at 12 weeks

    Self-reported treatment credibility, treatment Credibility Scale (TCS), 5 items

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • PBM Sweden AB

Registry information

Official study title

Multiprofessional Rehabilitation for Exhaustion Disorder

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 2, 2017
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.