NCT07407829 Step by Step Back - A Feasibility Study of a Physical Activity Intervention for Adults With Stress-related Exhaustion
| NCT ID | NCT07407829 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Swedish School of Sport and Health Sciences |
| Condition | Exhaustion Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-11-13 |
| Primary Completion | 2026-10-01 |
Trial Parameters
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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.
Eligibility Criteria
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 o