- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437833
Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
February 23, 2026 updated by: Poznan University of Physical Education
Psychophysiological Responses to Six 15-Minute Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder: A Single-Case Study
This study aims to explore how six short, 15-minute self-regulation techniques affect the body and brain in a female adult with ADHD and stabilized bipolar disorder. The techniques being tested include:
- Aerobic exercise
- Controlled breathing (cyclic sighing)
- Aromatherapy with lavender essential oil
- Listening to specific music (Solfeggio 528 Hz)
- Virtual reality relaxation with forest imagery
- Emotional Freedom Technique (EFT) tapping One session of quiet sitting with eyes open serves as a comparison.
The participant will attend one 15-minute session per week for each technique. Before and after each session, the researchers will measure:
- Heart rate and heart rate variability
- Stress levels using Subjective Units of Distress Scale
- Mood using a questionnaire
- Blood pressure
- Brain activity using EEG
- Memory performance with a simple test (N-back)
- Pain sensitivity The goal is to understand how these short, non-invasive techniques influence both physiological and psychological responses. Sessions are safe, short, and designed to involve minimal risk. The findings may help guide future research on relaxation and exercise strategies for people with ADHD and bipolar disorder.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Beata Jóźwiak
- Phone Number: (61) 835 53 49
- Email: b.jozwiak@awf.poznan.pl
Study Locations
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Poznan, Poland
- Poznan University of Physical Education
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Contact:
- Szerment
- Phone Number: (61) 835 51 12
- Email: szerment@awf.poznan.pl
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of ADHD and bipolar disorder (type I or II) in stable remission.
- No active depressive, manic, or psychotic episodes for at least 2 years.
- No use of psychotropic medications, including mood stabilizers, antidepressants, antipsychotics, or ADHD medications, for at least 2 years.
- No chronic somatic diseases (including neurological, cardiovascular, or metabolic disorders).
- Regular sleep-wake rhythm during the week preceding the study.
- Non-smoker.
- No night-shift work in the week preceding the study.
Exclusion Criteria:
- Acute medical conditions that could affect study procedures.
- Use of medications in the past 3 months that influence cardiovascular or neurological parameters.
- Consumption of alcohol or psychoactive substances on the day before or day of the study.
- Intense physical activity on the day before or day of the study.
- Contraindications to moderate-intensity exercise on a cycle ergometer (e.g., recent injuries, chronic musculoskeletal conditions).
- Contraindications to EEG measurement (e.g., scalp skin conditions preventing proper electrode placement, hypersensitivity to conductive gels or pastes).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: All Interventions and Control Session - Single Participant
One participant receives six 15-minute self-regulation interventions (moderate-intensity aerobic exercise on cycloergometer, cyclic sighing, lavender aromatherapy, Solfeggio 528 Hz music therapy, virtual reality forest relaxation, Emotional Freedom Technique tapping) and one control session (quiet sitting).
Each session occurs weekly, and measurements are taken before and after each session.
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The participant performs a 15-minute session of moderate-intensity cycling on a stationary ergometer.
Moderate intensity is defined as 64-76% of maximum heart rate according to ACSM guidelines.
The exercise load is set to 2 watts per kilogram of body weight.
Heart rate is monitored using a Polar chest strap.
Other Names:
The participant performs cyclic sighing for 15 minutes while sitting in a chair.
They inhale slowly, and once the lungs are expanded, perform a second inhale to maximally fill the lungs, even if the second inhale is shorter or smaller in volume than the first.
They then slowly and fully exhale all their breath.
The participant performs all inhales and exhales through the nose.
Other Names:
The participant undergoes a 15-minute aromatherapy session while sitting comfortably in a chair in a closed room (2 m × 4 m).
Lavender essential oil is diffused into the air using an aroma diffuser placed approximately 1 meter from the participant.
The participant breathes normally and does not perform controlled breathing.
Other Names:
The participant listens to 528 Hz solfeggio frequency music for 15 minutes while seated comfortably in a quiet, closed room.
Music is delivered through headphones or a speaker at a comfortable volume.
Other Names:
The participant wears a VR headset and views a 15-minute immersive forest and nature environment while seated comfortably in a quiet, closed room.
The VR experience includes visual and auditory elements of a natural forest scene.
Other Names:
The participant performs a 15-minute Emotional Freedom Technique (EFT) tapping session while seated comfortably in a quiet, closed room.
The participant taps on standardized acupressure points in the following order: karate chop (side of hand), inner eyebrow, side of eye, under eye, under nose, chin, collarbone, under arm, and top of head.
Each point is tapped 10-15 times with steady, moderate pressure.
Other Names:
The participant sits quietly in a chair with eyes open for 15 minutes in a calm, closed room.
No active intervention, tapping, breathing exercises, music, aromatherapy, or virtual reality is administered during this session.
The participant is instructed to remain seated with eyes open maintaining a natural posture without engaging in any structured activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean EEG spectral power in theta, alpha, low beta, high beta, gamma frequency bands during resting-state (eyes-open and eyes-closed)
Time Frame: Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period
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Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from resting-state EEG recordings collected during eyes-open and eyes-closed conditions.
Spectral power will be calculated separately for eyes-open and eyes-closed resting-state conditions.
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Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period
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Heart Rate Variability (HRV)
Time Frame: Baseline (average over 5-minute resting-state immediately before intervention); During intervention (average over entire session, periprocedural); Post-intervention (average over 5-minute resting-state immediately after intervention).
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HRV will be recorded at three time points.
Baseline HRV will be calculated as the average over a 5-minute resting-state period immediately before intervention.
HRV during the intervention will be calculated as the average over the entire intervention session (periprocedural).
Post-intervention HRV will be calculated as the average over a 5-minute resting-state period immediately after intervention.
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Baseline (average over 5-minute resting-state immediately before intervention); During intervention (average over entire session, periprocedural); Post-intervention (average over 5-minute resting-state immediately after intervention).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during N-back task
Time Frame: Baseline (during N-back task immediately before each intervention session, periprocedural); Post-intervention (during N-back task immediately after each intervention session, periprocedural)
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Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from EEG recordings collected during performance of the N-back cognitive task.
Spectral power will be calculated separately for each frequency band and averaged across all EEG channels.
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Baseline (during N-back task immediately before each intervention session, periprocedural); Post-intervention (during N-back task immediately after each intervention session, periprocedural)
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Blood Pressure
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
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Systolic and diastolic blood pressure measured using standard protocols.
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Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
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Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during intervention session
Time Frame: During intervention session (periprocedural, averaged over entire session).
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Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from EEG recordings collected during the intervention session.
Spectral power will be calculated separately for each frequency band and averaged across all EEG channels.
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During intervention session (periprocedural, averaged over entire session).
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Perceived Stress measured with the Subjective Units of Distress Scale (SUDS)
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
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The participant rates their perceived stress using the Subjective Units of Distress Scale (SUDS), a self-reported scale ranging from 0 (no stress) to 100 (extreme stress), where higher scores indicate higher perceived stress.
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Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
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Cognitive Performance (N-back)
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
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Working memory assessed using N-back test with Emotiv app.
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Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
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Pain Threshold
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
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Pain threshold measured using a dolorimeter (algorimeter).
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Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
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Positive and Negative Affect measured with the Positive and Negative Affect Schedule - Short Form (PANAS-SF)
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
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The participant completes the Positive and Negative Affect Schedule - Short Form (PANAS-SF), a self-reported scale assessing positive and negative affect.
Each subscale contains 10 items rated from 1 (very slightly or not at all) to 5 (extremely), giving a possible score range of 10-50 for each subscale.
Higher scores indicate higher levels of positive or negative affect, depending on the subscale.
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Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
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Heart Rate
Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
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Heart rate measured using standard protocols.
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Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Psychological Well-Being measured with the Short Version of Ryff's Psychological Well-Being Scale
Time Frame: Day before first intervention.
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The participant completes the Short Version of Ryff's Psychological Well-Being Scale, a self-reported questionnaire assessing psychological well-being across multiple dimensions.
Items are rated on a scale from 1 (strongly disagree) to 6 (strongly agree), giving a total possible score range of 18-108, where higher scores indicate higher levels of psychological well-being.
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Day before first intervention.
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Trait Mindfulness measured with the Mindful Attention Awareness Scale (MAAS)
Time Frame: Day before first intervention.
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The participant completes the Mindful Attention Awareness Scale (MAAS), a self-reported questionnaire measuring trait mindfulness.
Items are rated on a scale from 1 (almost always) to 6 (almost never), with total scores ranging from 15 to 90.
Higher scores indicate higher levels of trait mindfulness.
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Day before first intervention.
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Coping with Stress measured with the Brief COPE Inventory (mini-COPE)
Time Frame: Day before first intervention.
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The participant completes the Brief COPE Inventory (mini-COPE), a self-reported questionnaire assessing coping strategies and stress management.
Each item is rated on a scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot), with total subscale scores ranging from 2 to 8, depending on the subscale.
Higher scores indicate greater use of the specific coping strategy.
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Day before first intervention.
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Chronotype measured with the Morningness-Eveningness Questionnaire (MEQ)
Time Frame: Day before first intervention.
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The participant completes the Morningness-Eveningness Questionnaire (MEQ) to assess chronotype, indicating morningness-eveningness preference.
Items are scored to give a total score ranging from 16 to 86, where higher scores indicate greater morningness and lower scores indicate greater eveningness.
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Day before first intervention.
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Global Physical Activity measured with the Global Physical Activity Questionnaire (GPAQ)
Time Frame: Day before first session.
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The participant completes the Global Physical Activity Questionnaire (GPAQ) to assess baseline physical activity levels.
Responses are used to calculate total physical activity expressed in MET-minutes per week, with higher scores indicating higher levels of physical activity.
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Day before first session.
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Sleep Quality and Duration (Pittsburgh Sleep Quality Index)
Time Frame: Day before first session.
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The participant completes the Pittsburgh Sleep Quality Index (PSQI) to assess sleep quality and average sleep duration.
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Day before first session.
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Objective Sleep and Physical Activity (Polar Ignite)
Time Frame: During the 1-week washout period between intervention sessions.
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The participant wears Polar Ignite wrist-worn device to monitor sleep quality and duration, as well as daily physical activity levels.
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During the 1-week washout period between intervention sessions.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ida Laudańska-Krzemińska, Poznan University of Physical Education
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
February 23, 2026
First Submitted That Met QC Criteria
February 23, 2026
First Posted (Actual)
February 27, 2026
Study Record Updates
Last Update Posted (Actual)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 23, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Bipolar and Related Disorders
- Mental Disorders
- Mood Disorders
- Neurodevelopmental Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Bipolar Disorder
- Attention Deficit Disorder with Hyperactivity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Mind-Body Therapies
- Complementary Therapies
- Exercise Movement Techniques
- Physical Therapy Modalities
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Phytotherapy
- Exercise
- Breathing Exercises
- Music Therapy
- Aromatherapy
Other Study ID Numbers
- 716/25_2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This study involves a single participant.
All relevant results will be reported in the published manuscript.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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