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

Burnout, Professional Clinical Trial

Official title:

Multiprofessional Rehabilitation for Exhaustion Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360136
• Other study ID #: 2016/1834- 31/2
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 29, 2020

Study information

• Verified date: February 2023
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 29, 2020
• Est. primary completion date: December 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Adjustment Disorders
• Burnout Syndrome
• Burnout, Professional
• Burnout, Psychological
• Disease
• Exhaustion; Syndrome
• Syndrome

Intervention

Behavioral:
• Multi-professional CBT-rehabilitation
See "Detailed description"

Locations

Country	Name	City	State
Sweden	PBM Sweden AB Globen	Stockholm	Södermanland
Sweden	PBM Sweden City	Stockholm	Uppland

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	PBM Sweden AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Negative Effects of psychotherapy	Self-Reported negative effects in Negative Effects Questionnaire, 32 items	at 24 week only
Other	Treatment credibility rating	Self-reported treatment credibility, treatment Credibility Scale (TCS), 5 items	Baseline and at 12 weeks
Primary	Change from baseline in exhaustion symptoms	Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items	Week 12 and 24
Primary	Change from baseline to follow-up in exhaustion symptoms	Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items	Week 12, 24 and 76
Primary	Change from baseline in depression	Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items	Week 12 and 24
Primary	Change from baseline to follow-up in depression	Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items	Week 12, 24 and 76
Primary	Change from baseline in anxiety	Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items	Week 12 and 24
Primary	Change from baseline to follow-up in anxiety	Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items	Week 12, 24 and 76
Primary	Change from baseline in employment rate	Sick-leave data collected from the Swedish Social Insurance Agency	Week 24
Primary	Change from baseline to follow-up in employment rate	Sick-leave data collected from the Swedish Social Insurance Agency	Week 24 and 76
Secondary	Change from baseline in Quality of life	Self-reported change in EQ5D, 5 items	Week 24
Secondary	Change from baseline to follow-up in Quality of life	Self-reported change in EQ5D, 5 items	Week 24 and 76
Secondary	Change from baseline in insomnia symptoms	Self-reported change in Insomnia Severity Index (ISI), 7 items	Week 12 and 24
Secondary	Change from baseline to follow-up in insomnia symptoms	Self-reported change in Insomnia Severity Index (ISI), 7 items	Week 12, 24 and 76
Secondary	Change from baseline in Clinical Perfectionism	Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items	Week 12 and 24
Secondary	Change from baseline to follow-up in Clinical Perfectionism	Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items	Week 12, 24 and 76
Secondary	Change from baseline in Psychological Flexibility	Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items	Week 12 and 24
Secondary	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
Secondary	Change from baseline in pathological worry	Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items	Week 12 and 24
Secondary	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
Secondary	Change from baseline in perceived work ability	Self-rated work ability, 1 single item from Work Ability index (WAI)	Week 12 and 24
Secondary	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
Secondary	Change from baseline in burnout	Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items	Week 12 and 24
Secondary	Change from baseline to follow-up in burnout	Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items	Week 12, 24 and 76