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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-64
SponsorThe Swedish School of Sport and Health Sciences

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Experimental: Clinician-guided physical activity program integrated into treatment as usualExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
Up to 6 months

Secondary outcomes

1

Session attendance (intervention dose received)

Attendance will be assessed as the number of intervention sessions attended during the program, recorded by the treating clinician (licensed psychologist or psychotherapist).

Time frame
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).
2

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

Adherence will be assessed through clinician-recorded completion of assigned home exercises and through participant-reported physical activity engagement in the weekly activity log.

Time frame
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).
3

Intervention fidelity (delivery according to protocol)

Fidelity will be assessed using clinicians' structured self-report documentation of delivered intervention components, recorded using a session documentation template and compared with the intended intervention protocol.

Time frame
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).
4

Safety (adverse events)

Safety will be assessed by documentation of any reported or observed adverse events (physical or psychological) during the intervention period by the treating clinician (licensed psychologist or psychotherapist), and by self-report in post-program questionnaire. Reasons for discontinuation will be documented to identify any adverse-event-related attrition.

Time frame
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.

Other outcomes

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