Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:24 AM
Study NCT ID:
NCT07437833
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D001945', 'term': 'Breathing Exercises'}, {'id': 'D019341', 'term': 'Aromatherapy'}, {'id': 'D009147', 'term': 'Music Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D008517', 'term': 'Phytotherapy'}, {'id': 'D026421', 'term': 'Sensory Art Therapies'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Psychological Well-Being measured with the Short Version of Ryff's Psychological Well-Being Scale", 'timeFrame': 'Day before first intervention.', 'description': "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."}, {'measure': 'Trait Mindfulness measured with the Mindful Attention Awareness Scale (MAAS)', 'timeFrame': 'Day before first intervention.', 'description': '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.'}, {'measure': 'Coping with Stress measured with the Brief COPE Inventory (mini-COPE)', 'timeFrame': 'Day before first intervention.', 'description': "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."}, {'measure': 'Chronotype measured with the Morningness-Eveningness Questionnaire (MEQ)', 'timeFrame': 'Day before first intervention.', 'description': '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.'}, {'measure': 'Global Physical Activity measured with the Global Physical Activity Questionnaire (GPAQ)', 'timeFrame': 'Day before first session.', 'description': '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.'}, {'measure': 'Sleep Quality and Duration (Pittsburgh Sleep Quality Index)', 'timeFrame': 'Day before first session.', 'description': 'The participant completes the Pittsburgh Sleep Quality Index (PSQI) to assess sleep quality and average sleep duration.'}, {'measure': 'Objective Sleep and Physical Activity (Polar Ignite)', 'timeFrame': 'During the 1-week washout period between intervention sessions.', 'description': 'The participant wears Polar Ignite wrist-worn device to monitor sleep quality and duration, as well as daily physical activity levels.'}], 'primaryOutcomes': [{'measure': 'Mean EEG spectral power in theta, alpha, low beta, high beta, gamma frequency bands during resting-state (eyes-open and eyes-closed)', 'timeFrame': 'Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period', 'description': '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.'}, {'measure': 'Heart Rate Variability (HRV)', 'timeFrame': '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).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during N-back task', 'timeFrame': 'Baseline (during N-back task immediately before each intervention session, periprocedural); Post-intervention (during N-back task immediately after each intervention session, periprocedural)', 'description': '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.'}, {'measure': 'Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during intervention session', 'timeFrame': 'During intervention session (periprocedural, averaged over entire session).', 'description': '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.'}, {'measure': 'Perceived Stress measured with the Subjective Units of Distress Scale (SUDS)', 'timeFrame': 'Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session', 'description': '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.'}, {'measure': 'Cognitive Performance (N-back)', 'timeFrame': 'Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.', 'description': 'Working memory assessed using N-back test with Emotiv app.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session', 'description': 'Systolic and diastolic blood pressure measured using standard protocols.'}, {'measure': 'Pain Threshold', 'timeFrame': 'Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.', 'description': 'Pain threshold measured using a dolorimeter (algorimeter).'}, {'measure': 'Positive and Negative Affect measured with the Positive and Negative Affect Schedule - Short Form (PANAS-SF)', 'timeFrame': 'Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session', 'description': '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.'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session.', 'description': 'Heart rate measured using standard protocols.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ADHD - Attention Deficit Disorder With Hyperactivity', 'Bipolar Affective Disorder; Remission in']}, 'descriptionModule': {'briefSummary': '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:\n\n* Aerobic exercise\n* Controlled breathing (cyclic sighing)\n* Aromatherapy with lavender essential oil\n* Listening to specific music (Solfeggio 528 Hz)\n* Virtual reality relaxation with forest imagery\n* Emotional Freedom Technique (EFT) tapping One session of quiet sitting with eyes open serves as a comparison.\n\nThe participant will attend one 15-minute session per week for each technique. Before and after each session, the researchers will measure:\n\n* Heart rate and heart rate variability\n* Stress levels using Subjective Units of Distress Scale\n* Mood using a questionnaire\n* Blood pressure\n* Brain activity using EEG\n* Memory performance with a simple test (N-back)\n* 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ADHD and bipolar disorder (type I or II) in stable remission.\n* No active depressive, manic, or psychotic episodes for at least 2 years.\n* No use of psychotropic medications, including mood stabilizers, antidepressants, antipsychotics, or ADHD medications, for at least 2 years.\n* No chronic somatic diseases (including neurological, cardiovascular, or metabolic disorders).\n* Regular sleep-wake rhythm during the week preceding the study.\n* Non-smoker.\n* No night-shift work in the week preceding the study.\n\nExclusion Criteria:\n\n* Acute medical conditions that could affect study procedures.\n* Use of medications in the past 3 months that influence cardiovascular or neurological parameters.\n* Consumption of alcohol or psychoactive substances on the day before or day of the study.\n* Intense physical activity on the day before or day of the study.\n* Contraindications to moderate-intensity exercise on a cycle ergometer (e.g., recent injuries, chronic musculoskeletal conditions).\n* Contraindications to EEG measurement (e.g., scalp skin conditions preventing proper electrode placement, hypersensitivity to conductive gels or pastes).'}, 'identificationModule': {'nctId': 'NCT07437833', 'briefTitle': 'Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Physical Education'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '716/25_2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All Interventions and Control Session - Single Participant', '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.', 'interventionNames': ['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': [{'name': 'Moderate-Intensity Aerobic Exercise on Cycloergometer', 'type': 'BEHAVIORAL', 'otherNames': ['Physical Exercise'], 'description': '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.', 'armGroupLabels': ['All Interventions and Control Session - Single Participant']}, {'name': 'Cyclic Sighing', 'type': 'BEHAVIORAL', 'otherNames': ['Breathing Exercises'], 'description': '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.', 'armGroupLabels': ['All Interventions and Control Session - Single Participant']}, {'name': 'Aromatherapy', 'type': 'BEHAVIORAL', 'otherNames': ['Lavender Essential Oil Inhalation'], 'description': '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.', 'armGroupLabels': ['All Interventions and Control Session - Single Participant']}, {'name': 'Music Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Solfeggio 528 Hz Frequency Music Exposure'], 'description': '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.', 'armGroupLabels': ['All Interventions and Control Session - Single Participant']}, {'name': 'Virtual Reality Nature Immersion', 'type': 'BEHAVIORAL', 'otherNames': ['VR Relaxation'], 'description': '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.', 'armGroupLabels': ['All Interventions and Control Session - Single Participant']}, {'name': 'Emotional Freedom Technique Tapping', 'type': 'BEHAVIORAL', 'otherNames': ['Tapping on Acupuncture Points'], 'description': '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.', 'armGroupLabels': ['All Interventions and Control Session - Single Participant']}, {'name': 'Resting State (Control Session)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['All Interventions and Control Session - Single Participant']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Poznan', 'country': 'Poland', 'contacts': [{'name': 'Szerment', 'role': 'CONTACT', 'email': 'szerment@awf.poznan.pl', 'phone': '(61) 835 51 12'}], 'facility': 'Poznan University of Physical Education', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Beata Jóźwiak', 'role': 'CONTACT', 'email': 'b.jozwiak@awf.poznan.pl', 'phone': '(61) 835 53 49'}], 'overallOfficials': [{'name': 'Ida Laudańska-Krzemińska', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Poznan University of Physical Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'This study involves a single participant. All relevant results will be reported in the published manuscript.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Physical Education', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}