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NCT07437833

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

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 6 months later.

See at-risk trials from Poznan University of Physical Education

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 30, 2026 to Apr 30, 2027
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 3 of 8 entries
  2. Recruitment opened
    • Start date changed from estimate of Apr 1, 2026 to Jul 31, 2026
    • Primary and study completion dates pushed to Oct 30, 2026
    • Site details revised
    v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

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
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).

Secondary (8)

Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during N-back task
Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during intervention session
Perceived Stress measured with the Subjective Units of Distress Scale (SUDS)
Cognitive Performance (N-back)
Blood Pressure
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Pain Threshold
Positive and Negative Affect measured with the Positive and Negative Affect Schedule - Short Form (PANAS-SF)
Heart Rate

Arms and interventions

All Interventions and Control Session - Single ParticipantOther

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, Cyclic Sighing, Aromatherapy, Music Therapy, Virtual Reality Nature Immersion, Emotional Freedom Technique Tapping, Resting State (Control Session)

Sites

1 site in 1 country

  • Poznan University of Physical EducationPoznan, Poland