Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
ID: NCT07437833
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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.
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.
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.
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.
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.
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.
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.
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 Arms Description
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.
- 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.
- 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).
Primary Outcome Measures
- 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.
- 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.
View Secondary Outcome Measures (8)
- 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.
- 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.
- 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.
- 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.
- 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.
- Pain Threshold — Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
Pain threshold measured using a dolorimeter (algorimeter).
- 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.
- Heart Rate — Time Frame: Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.
Heart rate measured using standard protocols.
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
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View Official Medical/Scientific 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