Skip to main content
OpenTrials
Completed

NCT Number: NCT05811156

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exhaustion Disorder Clinical Burnout

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

PBM Sweden AB Globen

Stockholm, Södermanland County, 12177, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hybrid Multimodal digital intervention

Behavioral

Multimodal digital intervention, including an internet-delivered CBT treatment based on a biopsychosocial exposure treatment, tailored explicitly for Exhaustion due to persistent non-traumatic stress.

Other names: Internet CBT

Primary outcomes

  1. Karolinska Exhaustion Disorder Scale

    Time frame: 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

    Measures symptoms of Exhaustion. It is specifically tailored to measure symptoms from the Swedish diagnosis of Stress-induced exhaustion disorder.

Secondary outcomes

  1. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up

    Measure of depression and anxiety

  2. Flourishing scale

    Time frame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up

    brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism

  3. The current percentage of working time and sick-leave

    Time frame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up

    Rated by independent rater through telephone interview

  4. WHO Disability Assessment Schedule 2.0-12 (Rated by independent rater)

    Time frame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up

    Measures difficulties due to health conditions

  5. Client satisfaction Questionnaire- 8

    Time frame: immediately after treatment

    Measure of treatment satisfaction

  6. Negative Effects Questionnaire

    Time frame: immediately after treatment

    Measures negative effects attributable to treatment

Other outcomes

  1. Perfectionistic concerns, sub scale av Clinical Perfectionism Questionnaire

    Time frame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,

    A measure of perfectionistic concerns, a putative process variable in treatment

  2. Penn-state worry questionnaire-brief

    Time frame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,

    A measure of pathological worry, a putative process variable in treatment

  3. Psy-flex

    Time frame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,

    A measure of psychological flexibility, a putative process variable in treatment

  4. Insomnia severity index (3-item version)

    Time frame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,

    A measure of psychological dimensions of insomnia, a putative process variable in treatment

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • PBM Sweden AB

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 13, 2023
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.