A Biopsychosocial Treatment for Exhaustion Due to Persistent Non-traumatic Stress

A Biopsychosocial Treatment Model for Exhaustion Due to Persistent Non-traumatic Stress, Administered Through a Multimodal Digital Intervention - A Pilot Study

Currently, there are no established theoretical models for developing and maintaining Exhaustion due to persistent non-traumatic stress (ENTS). Therefore, the current pilot study aims to evaluate a Multimodal hybrid intervention built around an internet-delivered cognitive behavioral therapy based on a new biopsychosocial treatment model of ENTS.

Study Overview

• Status: Active, not recruiting
• Conditions: Exhaustion Disorder; Clinical Burnout
• Intervention / Treatment: Behavioral: Hybrid Multimodal digital intervention

Detailed Description

Since 2009 long term sick-leave rates due to mental disorders have been increasing in Sweden and are today the leading cause of long-term sick leave. Exhaustion due to persistent non-traumatic stress (ENTS) accounts for most of this increase. Unfortunately, despite several published treatment studies, no evidence-based treatments exist for ENTS, and little is still known about the focus of treatment.

Currently, there are no established theoretical models for the development and maintenance of ENTS. Many of the published clinical ENTS trials consist of long (6 months or more) Multimodal interventions (MMI) containing various medical, psychological, and physiotherapeutic methods with a low degree of understanding of what components are critical for treatment success. Even if ENTS patients participating in MMI report symptom improvements and work resumption, MMI is generally personnel intensive and challenging to administer. These factors increase the risk of extended healthcare lead times and obstruct treatment dissemination.

Considering the increasing sick-leave rates due to ENTS, there is an apparent need for more accessible treatments based on pronounced theoretical models focusing on specific change processes. Therefore, the current pilot study aims to evaluate a hybrid MMI built around an internet-delivered cognitive behavioral therapy based on a new biopsychosocial treatment model of ENTS.

Outcome measures will be collected before and after treatment and at three and six-month follow-ups. Weekly measurements of putative processes of change will also be collected. The current study aims to evaluate whether this more restricted and theoretically coherent hybrid MMI shows promising results before we test the treatment solely as a cognitive behavioral therapy via the internet in a randomized controlled trial.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

• Study Contact: Name: Monica Buhrman, Associate professor; Phone Number: +46 733468539; Email: monica.buhrman@psyk.uu.se
• Study Contact Backup: Name: Jakob Clason van de Leur, PhD-student; Phone Number: 0735353938; Email: jakob.clason-vandeleur@psyk.uu.se

Study Locations

• Sweden
  • Södermanland
    • Stockholm, Södermanland, Sweden, 12177
      • PBM Sweden AB Globen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with SED who are accepted to treatment for a Multimodal digital intervention within a specialized healthcare initiative called "The healthcare choice for treatment of longstanding pain with or without comorbidity, and SED."

Description

Inclusion Criteria:

• Referred for Stress-induced exhaustion disorder (SED)
• Fulfilled the criteria for SED
• Scored > 5 on the Shirom-Melamed Burnout Questionnaire (a cut-off determined by the Health Care Services Stockholm County)
• Scored 19 > on Karolinska Exhaustion Disorder Scale
• In need of sick-leave due to SED d) access to internet

Exclusion Criteria:

• 100 % sick leave of more than one year
• abuse of alcohol or drugs
• participating in any other form of MMI
• severe depression, moderate/high risk of suicide, psychosis, or untreated PTSD.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Karolinska Exhaustion Disorder Scale	Measures symptoms of Exhaustion. It is specifically tailored to measure symptoms from the Swedish diagnosis of Stress-induced exhaustion disorder.	Baseline measurement, weekly (up to 12 weeks) change during from treatment baseline to immediately after treatment, change between immediately after treatment and 3 months follow-up, change between 3 months follow up and 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Anxiety and Depression Scale (HADS)	Measure of depression and anxiety	Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
Flourishing scale	brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism	Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
The current percentage of working time and sick-leave	Rated by independent rater through telephone interview	Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
WHO Disability Assessment Schedule 2.0-12 (Rated by independent rater)	Measures difficulties due to health conditions	Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
Client satisfaction Questionnaire- 8	Measure of treatment satisfaction	immediately after treatment
Negative Effects Questionnaire	Measures negative effects attributable to treatment	immediately after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfectionistic concerns, sub scale av Clinical Perfectionism Questionnaire	A measure of perfectionistic concerns, a putative process variable in treatment	weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Penn-state worry questionnaire-brief	A measure of pathological worry, a putative process variable in treatment	weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Psy-flex	A measure of psychological flexibility, a putative process variable in treatment	weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Insomnia severity index (3-item version)	A measure of psychological dimensions of insomnia, a putative process variable in treatment	weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: PBM Sweden AB

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): April 13, 2023

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID Numbers: 2022-06789-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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