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

February 17, 2023 updated by: Uppsala University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline in exhaustion symptoms
Time Frame: Week 12 and 24
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Week 12 and 24
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
Week 12, 24 and 76
Change from baseline in depression
Time Frame: Week 12 and 24
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Week 12 and 24
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
Week 12, 24 and 76
Change from baseline in anxiety
Time Frame: Week 12 and 24
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Week 12 and 24
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
Week 12, 24 and 76
Change from baseline in employment rate
Time Frame: Week 24
Sick-leave data collected from the Swedish Social Insurance Agency
Week 24
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
Week 24 and 76

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Quality of life
Time Frame: Week 24
Self-reported change in EQ5D, 5 items
Week 24
Change from baseline to follow-up in Quality of life
Time Frame: Week 24 and 76
Self-reported change in EQ5D, 5 items
Week 24 and 76
Change from baseline in insomnia symptoms
Time Frame: Week 12 and 24
Self-reported change in Insomnia Severity Index (ISI), 7 items
Week 12 and 24
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
Week 12, 24 and 76
Change from baseline in Clinical Perfectionism
Time Frame: Week 12 and 24
Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items
Week 12 and 24
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
Week 12, 24 and 76
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
Week 12 and 24
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
Week 12, 24 and 76
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
Week 12 and 24
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
Week 12, 24 and 76
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)
Week 12 and 24
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)
Week 12, 24 and 76
Change from baseline in burnout
Time Frame: Week 12 and 24
Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items
Week 12 and 24
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
Week 12, 24 and 76

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Negative Effects of psychotherapy
Time Frame: at 24 week only
Self-Reported negative effects in Negative Effects Questionnaire, 32 items
at 24 week only
Treatment credibility rating
Time Frame: Baseline and at 12 weeks
Self-reported treatment credibility, treatment Credibility Scale (TCS), 5 items
Baseline and at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Uppsala University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PBM Sweden AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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