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

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.

Study Overview

• Status: Completed
• Conditions: Burnout, Professional; Burnout Syndrome; Adjustment Disorders; Exhaustion; Syndrome
• Intervention / Treatment: Behavioral: Multi-professional CBT-rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Södermanland
    • Stockholm, Södermanland, Sweden, 12177
      • PBM Sweden AB Globen
  • Uppland
    • Stockholm, Uppland, Sweden, 114 47
      • PBM Sweden City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Multi-professional CBT-rehabilitation; 24 weeks CBT-based multi-professional rehabilitation.	Behavioral: Multi-professional CBT-rehabilitation; See "Detailed description"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Quality of life	Self-reported change in EQ5D, 5 items	Week 24
Change from baseline to follow-up in Quality of life	Self-reported change in EQ5D, 5 items	Week 24 and 76
Change from baseline in insomnia symptoms	Self-reported change in Insomnia Severity Index (ISI), 7 items	Week 12 and 24
Change from baseline to follow-up in insomnia symptoms	Self-reported change in Insomnia Severity Index (ISI), 7 items	Week 12, 24 and 76
Change from baseline in Clinical Perfectionism	Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items	Week 12 and 24
Change from baseline to follow-up in Clinical Perfectionism	Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items	Week 12, 24 and 76
Change from baseline in Psychological Flexibility	Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items	Week 12 and 24
Change from baseline to follow-up in Psychological Flexibility	Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items	Week 12, 24 and 76
Change from baseline in pathological worry	Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items	Week 12 and 24
Change from baseline to follow-up in pathological worry	Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items	Week 12, 24 and 76
Change from baseline in perceived work ability	Self-rated work ability, 1 single item from Work Ability index (WAI)	Week 12 and 24
Change from baseline to follow up in perceived work ability	Self-rated work ability, 1 single item from Work Ability index (WAI)	Week 12, 24 and 76
Change from baseline in burnout	Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items	Week 12 and 24
Change from baseline to follow-up in burnout	Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items	Week 12, 24 and 76

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative Effects of psychotherapy	Self-Reported negative effects in Negative Effects Questionnaire, 32 items	at 24 week only
Treatment credibility rating	Self-reported treatment credibility, treatment Credibility Scale (TCS), 5 items	Baseline and at 12 weeks

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: PBM Sweden AB

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 29, 2020
• Study Completion (Actual): December 29, 2020

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 2, 2017

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Burnout; Exhaustion Disorder; Clinical Burnout
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Stress, Psychological; Occupational Stress; Occupational Diseases; Trauma and Stressor Related Disorders; Syndrome; Disease; Burnout, Professional; Burnout, Psychological; Adjustment Disorders
• Other Study ID Numbers: 2016/1834- 31/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No