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NCT Number: NCT07437833

Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder

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.

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Key information

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Bipolar Affective Disorder; Remission in Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Neurodevelopmental Disorders

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Moderate-Intensity Aerobic Exercise on Cycloergometer

Behavioral

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: Physical Exercise

Cyclic Sighing

Behavioral

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: Breathing Exercises

Aromatherapy

Behavioral

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: Lavender Essential Oil Inhalation

Music Therapy

Behavioral

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: Solfeggio 528 Hz Frequency Music Exposure

Virtual Reality Nature Immersion

Behavioral

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: VR Relaxation

Emotional Freedom Technique Tapping

Behavioral

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: Tapping on Acupuncture Points

Resting State (Control Session)

Behavioral

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.

Primary outcomes

  1. 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

    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.

  2. 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).

    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.

Secondary outcomes

  1. 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)

    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.

  2. 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).

    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.

  3. 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

    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.

  4. Cognitive Performance (N-back)

    Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.

    Working memory assessed using N-back test with Emotiv app.

  5. Blood Pressure

    Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session

    Systolic and diastolic blood pressure measured using standard protocols.

  6. Pain Threshold

    Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.

    Pain threshold measured using a dolorimeter (algorimeter).

  7. 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

    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.

  8. Heart Rate

    Time frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.

    Heart rate measured using standard protocols.

Other outcomes

  1. Psychological Well-Being measured with the Short Version of Ryff's Psychological Well-Being Scale

    Time frame: Day before first intervention.

    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.

  2. Trait Mindfulness measured with the Mindful Attention Awareness Scale (MAAS)

    Time frame: Day before first intervention.

    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.

  3. Coping with Stress measured with the Brief COPE Inventory (mini-COPE)

    Time frame: Day before first intervention.

    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.

  4. Chronotype measured with the Morningness-Eveningness Questionnaire (MEQ)

    Time frame: Day before first intervention.

    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.

  5. Global Physical Activity measured with the Global Physical Activity Questionnaire (GPAQ)

    Time frame: Day before first session.

    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.

  6. Sleep Quality and Duration (Pittsburgh Sleep Quality Index)

    Time frame: Day before first session.

    The participant completes the Pittsburgh Sleep Quality Index (PSQI) to assess sleep quality and average sleep duration.

  7. Objective Sleep and Physical Activity (Polar Ignite)

    Time frame: During the 1-week washout period between intervention sessions.

    The participant wears Polar Ignite wrist-worn device to monitor sleep quality and duration, as well as daily physical activity levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Beata Jóźwiak

CONTACT

[email protected]

(61) 835 53 49

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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