Step by Step Back - A Feasibility Study of a Physical Activity Intervention for Adults With Stres… (NCT07407829) | Clinical Trial Compass
RecruitingNot Applicable
Step by Step Back - A Feasibility Study of a Physical Activity Intervention for Adults With Stress-related Exhaustion
Sweden20 participantsStarted 2025-11-13
Plain-language 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.
Who can participate
Age range
20 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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, o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intervention completion (retention)
Timeframe: Up to 6 months
Trial details
NCT IDNCT07407829
SponsorThe Swedish School of Sport and Health Sciences