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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorPoznan University of Physical Education

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

1 Participants
are divided into 1 treatment group
Group A: All Interventions and Control Session - Single ParticipantOther 7 interventions

Trial outcomes

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)

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.

Time frame
Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period
2

Heart Rate Variability (HRV)

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.

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).

Secondary outcomes

1

Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during N-back task

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.

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)
2

Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during intervention 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.

Time frame
During intervention session (periprocedural, averaged over entire session).
3

Perceived Stress measured with the Subjective Units of Distress Scale (SUDS)

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.

Time frame
Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session
4

Cognitive Performance (N-back)

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

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

Other outcomes

1

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

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.

Time frame
Day before first intervention.
2

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

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.

Time frame
Day before first intervention.
3

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

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.

Time frame
Day before first intervention.
4

Chronotype measured with the Morningness-Eveningness Questionnaire (MEQ)

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.

Time frame
Day before first intervention.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.