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

NCT07437833 | Not Yet Recruiting

• 1 other identifier: 716/25_2
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity; Bipolar Affective Disorder; Remission in

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

  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 (8)

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

  Baseline (during N-back task immediately before each intervention session, periprocedural); Post-intervention (during N-back task immediately after each intervention session, periprocedural)

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

  During intervention session (periprocedural, averaged over entire session).

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

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

• Cognitive Performance (N-back)

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

• Blood Pressure

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

Other Outcomes (7)

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

  Day before first intervention.

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

  Day before first intervention.

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

  Day before first intervention.

Study Arms (1)

All Interventions and Control Session - Single Participant

OTHER

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.

Behavioral: Moderate-Intensity Aerobic Exercise on Cycloergometer; Behavioral: Cyclic Sighing; Behavioral: Aromatherapy; Behavioral: Music Therapy; Behavioral: Virtual Reality Nature Immersion; Behavioral: Emotional Freedom Technique Tapping; Behavioral: Resting State (Control Session)

Interventions

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.

Also known as: Physical Exercise

All Interventions and Control Session - Single Participant

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.

Also known as: Breathing Exercises

All Interventions and Control Session - Single Participant

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.

Also known as: Lavender Essential Oil Inhalation

All Interventions and Control Session - Single Participant

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.

Also known as: Solfeggio 528 Hz Frequency Music Exposure

All Interventions and Control Session - Single Participant

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.

Also known as: VR Relaxation

All Interventions and Control Session - Single Participant

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.

Also known as: Tapping on Acupuncture Points

All Interventions and Control Session - Single Participant

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.

All Interventions and Control Session - Single Participant

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Poznan University of Physical Education

Poznan, Poland

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Bipolar Disorder

Interventions

Exercise; Breathing Exercises; Aromatherapy; Music Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Officials

• Ida Laudańska-Krzemińska

  Poznan University of Physical Education

  STUDY DIRECTOR

Central Study Contacts

Beata Jóźwiak

CONTACT

(61) 835 53 49; b.jozwiak@awf.poznan.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This case study involves one participant who will receive six different 15-minute self-regulation interventions and one control session (quiet sitting) in separate weekly sessions. Each intervention is delivered once, and all measurements are taken before and after each session.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)