Step by Step Back - A Feasibility Study of a Physical Activity Intervention for Adults With Stress-related Exhaustion

NCT07407829 | Recruiting

• 1 other identifier: 2025-04555-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to learn whether a psychologist- or psychotherapist-guided physical activity program can be delivered and used as part of regular care for adults experiencing stress-related exhaustion. The program is designed to be integrated into regular psychological treatment as usual and supports participants in developing physical activity habits in a gradual, individualized, and sustainable way. The main questions this study aims to answer are:

• Can participants complete the program and attend the planned sessions?
• Do participants and clinicians find the program acceptable, relevant, and useful?
• Is the program safe, and do any negative experiences occur during the program?
• What practical barriers and facilitators affect participation and delivery in routine care?
• What descriptive patterns of change are seen in physical activity, symptoms, and everyday functioning from before to after the program? The program is based on cognitive behavioral therapy (CBT) and acceptance and commitment therapy (ACT). It includes strategies to help participants set meaningful goals, take step-by-step actions toward those goals, and respond more flexibly to uncomfortable thoughts, emotions, and body sensations that may arise in relation to physical activity. About 12 to 20 participants will take part. The program is designed to be integrated into about 5 to 6 individual sessions delivered over a flexible time period, depending on each participant's pace and circumstances. Participants will:
• Take part in the physical activity program as part of their regular psychological treatment
• Complete online questionnaires before and after the program
• Log their physical activity during the program
• Provide feedback after the program (and some participants will also take part in an interview) The results will be used to assess whether the program is feasible and acceptable for participants and clinicians and to inform further refinement and future evaluation.

Conditions

Exhaustion Disorder; Stress-Related Disorders

Keywords

Stress-related exhaustion; Exhaustion disorder; Fatigue; Burnout; Physical activity intervention; Exercise therapy; Feasibility study; Cognitive behavioral therapy (CBT); Acceptance and Commitment Therapy (ACT); Psychological flexibility

Outcome Measures

Primary Outcomes (1)

• Intervention completion (retention)

  Feasibility of the intervention will be primarily assessed by the proportion of participants who complete the intervention, defined as receiving a minimum dose of the program (attending at least 4 out of 6 intervention sessions delivered by a licensed psychologist or psychotherapist).

  Up to 6 months

Secondary Outcomes (15)

• Session attendance (intervention dose received)

  Throughout the intervention period (from first to last session; approximately 5-6 sessions delivered over a flexible time period, typically within about 2-6 months).

• Participant adherence to intervention activities (home tasks and physical activity)

  Throughout the intervention period (from first to last session; approximately 5-6 sessions delivered over a flexible time period, typically within about 2-6 months).

• Intervention fidelity (delivery according to protocol)

  Throughout the intervention period (from first to last session; approximately 5-6 sessions delivered over a flexible time period, typically within about 2-6 months).

• Safety (adverse events)

  Throughout the intervention period (from first to last session; approximately 5-6 sessions delivered over a flexible time period, typically within about 2-6 months) and post-program questionnaires approximately 1 week after program cessation.

• Participant acceptability and perceived fit (mixed methods)

  Post-intervention (at intervention completion; after approximately 5-6 sessions delivered over a flexible time period, typically within about 2-6 months).

Study Arms (1)

Experimental: Clinician-guided physical activity program integrated into treatment as usual

EXPERIMENTAL

Participants receive a clinician-guided physical activity program integrated into regular psychological treatment as usual. The program is manualized and individually tailored to support gradual and sustainable engagement in physical activity. It is designed to be integrated into approximately 5 to 6 individual sessions delivered by a licensed psychologist or psychotherapist over a flexible time period depending on the participant's pace and circumstances.

Behavioral: CBT/ACT-based psychologist-delivered physical activity program

Interventions

CBT/ACT-based psychologist-delivered physical activity program BEHAVIORAL

A structured psychologist-delivered physical activity program integrating Cognitive Behavioral Therapy (CBT) and Acceptance and Commitment Therapy (ACT) principles. It supports individuals with stress-related exhaustion in developing sustainable and value-based ways of being physically active. Core components include psychoeducation about fatigue and recovery, clarification of personal values, goal setting, and graded behavioral activation tailored to individual needs. The program consists of approximately 5-6 individual sessions, delivered by licensed psychologists over a flexible time period depending on the participant's pace and circumstances. Each session covers key themes such as understanding exhaustion and physical activity, identifying barriers and values, planning and adjusting activity, addressing unhelpful thoughts and emotions, and a flexible approach to physical activity (e.g. mode, frequency, duration, intensity). Between sessions, participants complete home exercises.

Experimental: Clinician-guided physical activity program integrated into treatment as usual

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult aged 20 to 64 years.
• Experiencing stress-related exhaustion, assessed in regular clinical care (for example, symptoms consistent with exhaustion disorder or a closely related stress-related condition).
• Symptoms are not in the acute phase (participant is able to engage in outpatient psychological treatment and gradual physical activity).
• Elevated fatigue/exhaustion at screening, indicated by scores on screening questionnaires (Karolinska Exhaustion Disorder Scale and Multidimensional Fatigue Inventory).
• Able to understand spoken and written Swedish.
• Has access to a smartphone, tablet, or computer with an internet connection to complete study questionnaires and activity logging.
• No medical condition that makes physical activity unsafe, based on clinical screening and participant self-report.

You may not qualify if:

• Currently receiving psychological treatment outside the recruiting clinic that is expected to interfere with participation in the program or study assessments.
• Current or past diagnosis of a psychotic disorder.
• Current or past diagnosis of bipolar disorder.
• Severe mental health condition requiring another primary treatment approach at this time (for example, severe major depressive disorder, post-traumatic stress disorder, or an eating disorder).
• Ongoing substance use disorder.
• Medical condition or acute illness that makes physical activity inappropriate at this time (for example, recent blood clot, severe infection, or other serious condition).
• Severe musculoskeletal condition that substantially limits ability to perform physical activity.
• Started antidepressant medication within the past 4 weeks.
• Additional notes (not eligibility criteria):
• Participants may use psychotropic medication (for example, antidepressants, sleep medication, or anxiety medication) if the medication regimen is stable. Participants will be asked to report any medication changes during the study period. Mild to moderate comorbid anxiety or depression is allowed if stress-related exhaustion is the primary clinical problem.

Sponsors & Collaborators

• The Swedish School of Sport and Health Sciences: lead
• Itrim: collaborator
• Avonova: collaborator

Study Sites (1)

Avonova Occupational Health

Stockholm, Sweden

RECRUITING

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MeSH Terms

Conditions

Fatigue; Burnout, Psychological

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Victoria Blom, Professor

  Department of Physical Activity and Health, The Swedish School of Sport and Health Sciences, Stockholm, Sweden.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Kling, MSc

CONTACT

+4670 182 62 21; jenny.kling@gih.se

Victoria Blom, Professor

CONTACT

0046707213029; victoria.blom@gih.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group, open-label interventional mixed-methods feasibility study evaluating a clinician-guided physical activity program integrated into psychological treatment as usual for adults experiencing stress-related exhaustion.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: February 12, 2026
• Study Start: November 13, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)