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

This study is currently recruiting participants.
Verified November 2017 by Uppsala University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03360136
First Posted: December 1, 2017
Last Update Posted: December 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
PBM Sweden AB
Information provided by (Responsible Party):
Uppsala University
  Purpose
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.

Condition Intervention
Exhaustion; Syndrome Burnout, Professional Burnout Syndrome Adjustment Disorders Behavioral: Multi-professional CBT-rehabilitation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Open Clinical Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multiprofessional Rehabilitation for Exhaustion Disorder

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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 to follow-up in exhaustion symptoms [ Time Frame: Week 12, 24 and 76 ]
    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 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 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


Secondary Outcome Measures:
  • Change from baseline in Quality of life [ Time Frame: Week 24 ]
    Self-reported change in EQ5D, 5 items

  • Change from baseline to follow-up in Quality of life [ Time Frame: Week 24 and 76 ]
    Self-reported change in EQ5D, 5 items

  • Change from baseline in insomnia symptoms [ Time Frame: Week 12 and 24 ]
    Self-reported change in Insomnia Severity Index (ISI), 7 items

  • 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

  • Change from baseline in Clinical Perfectionism [ Time Frame: Week 12 and 24 ]
    Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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)

  • 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)

  • Change from baseline in burnout [ Time Frame: Week 12 and 24 ]
    Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items

  • 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 Outcome Measures:
  • Negative Effects of psychotherapy [ Time Frame: at 24 week only ]
    Self-Reported negative effects in Negative Effects Questionnaire, 32 items

  • Treatment credibility rating [ Time Frame: Baseline and at 12 weeks ]
    Self-reported treatment credibility, treatment Credibility Scale (TCS), 5 items


Estimated Enrollment: 400
Actual Study Start Date: October 1, 2017
Estimated Study Completion Date: July 1, 2020
Estimated Primary Completion Date: July 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Multi-professional CBT-rehabilitation
24 weeks CBT-based multi-professional rehabilitation.
Behavioral: Multi-professional CBT-rehabilitation
See "Detailed description"

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360136


Contacts
Contact: Monica Buhrman, PhD 0184712126 ext +46 monica.buhrman@psyk.uu.se
Contact: Jakob Clason, PhD Student jakob.clason@psyk.uu.se

Locations
Sweden
PBM Sweden AB Globen Recruiting
Stockholm, Södermanland, Sweden, 12177
Contact: Gunilla Brodda Jansen, Assoc. Proff.    070-716 39 13 ext +46    gunillabroddajansen@pbm.se   
PBM Sweden City Recruiting
Stockholm, Uppland, Sweden, 114 47
Contact: Gunilla Brodda Jansen, Assoc. Proff.    070-716 39 13 ext +46    gunillabroddajansen@pbm.se   
Sponsors and Collaborators
Uppsala University
PBM Sweden AB
Investigators
Study Chair: Gunilla Brodda Jansen, Assoc. Proff. Karolinska University
  More Information

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT03360136     History of Changes
Other Study ID Numbers: 2016/1834- 31/2
First Submitted: November 27, 2017
First Posted: December 1, 2017
Last Update Posted: December 1, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uppsala University:
Exhaustion Disorder
Burnout
Clinical Burnout

Additional relevant MeSH terms:
Disease
Syndrome
Adjustment Disorders
Burnout, Professional
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Occupational Diseases