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

NCT05811156 | Completed

• 1 other identifier: 2022-06789-01
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Exhaustion Disorder; Clinical Burnout

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Hospital Anxiety and Depression Scale (HADS)

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

• Flourishing scale

  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

  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)

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

• Client satisfaction Questionnaire- 8

  immediately after treatment

Other Outcomes (4)

• Perfectionistic concerns, sub scale av Clinical Perfectionism Questionnaire

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

• Penn-state worry questionnaire-brief

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

• Psy-flex

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

Interventions

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.

Also known as: Internet CBT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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."

You may qualify if:

• 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

You may not qualify if:

• % 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.

Sponsors & Collaborators

• Uppsala University: lead
• PBM Sweden AB: collaborator

Study Sites (1)

PBM Sweden AB Globen

Stockholm, Södermanland County, 12177, Sweden

Location

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: April 13, 2023
• Study Start: February 14, 2023
• Primary Completion: December 31, 2023
• Study Completion: November 30, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)