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NCT Number: NCT07238153

Promoting Emotional and Autonomic Control Through Guided Breathing Exercises for Emerging Adults With Autism

This study examines the impact of guided breathing exercises on stress and heart rate variability (HRV) in autistic young adults. It explores how daily movement behavior (sleep, physical activity and sedentary behavior) influences HRV and to what extent two guided breathing exercises can affect HRV. Additionally, the study investigates how participants perceive the exercises in terms of usability and usefulness.

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Key information

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KU Leuven, Leuven, Vlaams Brabant, Belgium

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About this study

For many autistic individuals, transitioning into adulthood can be challenging and stressful. This stress often affects their mental health. The autistic community has highlighted the need for better mental health support, including accessible and effective ways to manage stress. Among the non-pharmacological interventions aimed at improving mental health via stress reduction, guided breathing interventions are promising, also on a psychophysiological level. During a stressful situation, internal regulatory processes take place to maintain balance, starting by activating the autonomic nervous system (ANS). Prior work indicates that a dysfunction of the ANS contributes to the heightened mental health challenges observed in autistic individuals. Heart rate variability (HRV), the variation in time between heartbeats, is an physiological index of the functioning of the ANS. The Neurovisceral Integration Theory highlights the role of parasympathetic regulation of the heart rate, associating higher vagally mediated HRV with better health, emotional regulation and executive functioning.In autistic individuals, the overall levels of cardiac vagal modulation are lower compared to neurotypical peers.

To date, research investigating the potential of interventions aimed at increasing HRV in autistic individuals is scarce. Moreover, HRV is influenced by several aspects (e.g., sleep, physical activity) and knowledge on their combined impact is necessary to understand how HRV can be used in research and clinical practice. Therefore, in this project, the investigators will explore the role of physical activity, sedentary behavior, and sleep on HRV and determine what constitutes a significant change in HRV.

The investigators will also examine the psychophysiological effects, feasibility, and acceptability of the two leading protocols in guided breathing interventions (heart rate variability biofeedback and slow-paced breathing). HRV-BF optimizes HRV by guiding individuals to breathe at their resonance frequency, synchronizing heart rate and breathing. SPB prescribes to breathe at a fixed pace of 6 breaths per minute.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For participants ≥18 years a voluntary written informed consent and for participants < 18 years a written informed consent from the parents or their legally authorized representative and an informed assent of the participant has been obtained prior to any screening procedures
  • Male or Female (biological)
  • Between 16 and 25 years old
  • Diagnosis of autism as described in the DSM-IV/DSM-5(-TR)

Exclusion criteria

  • Participant has a history of congenital heart diseases, diagnosed cardiovascular abnormalities or somatic diseases conditions that may interfere with the main outcome measure HRV or with the safe practice of breathing exercises (e.g., uncontrolled epilepsy, severe respiratory illness)
  • Presence of contra-indications for participating (intervention and/or assessment): acute agitation and/or severe psychiatric symptoms (psychosis, mania or major depression) and/or active substance use.
  • The presence of an intellectual disability, defined as an intelligence quotient < 70, as described in the DSM-IV/DSM-V.
  • Insufficient knowledge of Dutch language in order to follow instructions and fill out questionnaires.
  • Female who is pregnant.
  • Participation in another interventional study, with or without an investigational medicinal product (IMP) or device (IMD).
  • The use of medication known to affect cardiac modulation (excluding hormonal contraceptives).
  • Hearing- or vision impairment that cannot be corrected to normal functioning.

Treatment and study plan

Guided breathing exercise - SPB

Device

Guided breathing exercises are performed at a fixed pace of 6 breaths per minute (SPB) .

Guided breathing exercise - HRV-BF

Device

Guided breathing exercises are performed at each participant's individually determined resonance frequency, which typically falls between 4.5 and 7 breaths per minute (HRV-BF).

Primary outcomes

  1. Change in cardiac vagal modulation of heart rate based on resting-state HRV.

    Time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)

    Calculated as (1) a time domain measure (RMSSD: Root Mean Square of Successive Differences). Three-lead electrocardiographic data will be captured using the NeXus-10 MKII biofeedback device and Biotrace+ Software (MindMedia B.V., The Netherlands). Disposable, self-adhesive and pre-gelled electrodes (Kendall™ ECG Electrodes Arbo™ H124SG, Covidien, Ireland) will be used without specific skin preparations at a sampling rate of 256 SPS. For the recording of the breathing frequency, an elastic band with stretch-sensitive sensors and a sampling rate of 32 SPS is placed around the waist.

  2. Change in cardiac vagal modulation of heart rate based on resting-state HRV

    Time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)

    Calculated as (2) a frequency domain measures (HF-HRV). Three-lead electrocardiographic data will be captured using the NeXus-10 MKII biofeedback device and Biotrace+ Software (MindMedia B.V., The Netherlands). Disposable, self-adhesive and pre-gelled electrodes (Kendall™ ECG Electrodes Arbo™ H124SG, Covidien, Ireland) will be used without specific skin preparations at a sampling rate of 256 SPS. For the recording of the breathing frequency, an elastic band with stretch-sensitive sensors and a sampling rate of 32 SPS is placed around the waist.

Secondary outcomes

  1. Change in mental health indicators

    Time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)

    (1) Symptom Checklist-90 Revised (SCL-90-R): The Dutch version measures eight dimensions: anxiety (ANG), agoraphobia (AGO), depression (DEP), somatization (SOM), cognitive-performance deficits (IN), interpersonal sensitivity and mistrust (SEN), hostility (HOS), and sleep difficulties (SLA). Each item is rated on a 5-point Likert scale from 1 ("not at all") to 5 ("extremely"). The total score ranges from 90 to 450. The total score provides a general measure of psychological distress. Higher scores indicate more symptoms and distress.

    The scores on the eight dimensions range for ANG between 10 and 50, for AGO between 7 and 35, for DEP between 16 and 80, for SOM between 12 and 60, for IN between 9 and 45, for SEN between 18 and 90, for HOS between 6 and 30 and for SLA between 3 and 15. Higher scores indicate more symptoms and distress.

  2. Change in mental health indicators

    Time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)

    (2) Depression Anxiety Stress Scales (DASS-21): The Dutch version of the DASS-21 measures the presence of symptoms of depression, anxiety, and stress. In consists of 21 items and takes about 10 minutes to complete. Each item is rated on a 4-point Likert scale from 0 ("did not apply to me at all") to 3 ("applied to me very much, or most of the time"). The scale yields three subscale scores: Depression, Anxiety, and Stress, each based on 7 items. Subscale scores therefore range from 0 to 21. To calculate the scores, the subscale scores are multiplied by two, resulting in a final range of 0 to 42 per subscale. Higher scores indicate greater symptom severity.

  3. Change in mental health indicators

    Time frame: At all assessment points: at the start of the study (week 0, time point 0) before the intervention (week 5, time point 1) + after 5 weeks of intervention (week 10, time point 2) + after 5 weeks at the follow-up (week 15, time point 3)

    (3) Perceived stress scale (PSS-10): The Dutch version of the PSS measures the degree to which situations in one's life are appraised as stressful, that is, how unpredictable, uncontrollable, and overloaded respondents experience their lives. It consists of 10 items and takes maximum 5 minutes to complete. Each item is rated on a 5-point Likert scale ranging from 0 ("never") to 4 ("very often"). Four items are positively stated and are reverse-scored (item 4,5,7 en 8). Total scores range from 0 to 40, with higher scores indicating higher levels of perceived stress

  4. feasibility and acceptability of the HRV-BF and SPB interventions.

    Time frame: For 5 weeks 4 times per day (before and after each sessions) during the intervention phase (between week 5 and week 10)

    The investigators will explore how participants experience the guided breathing protocols, including their usability. This aspect will be assessed through a self-report questionnaire, including the registration of perceived stress before and after each sessions, using a Visual Analogue Scale (VAS) ranging from "none" to "a lot".

  5. feasibility and acceptability of the HRV-BF and SPB interventions.

    Time frame: For 5 weeks 4 times per day during the intervention phase (between week 5 and week 10)

    The investigators will explore how participants experience the guided breathing protocols, including their acceptability. This aspect will be assessed through a self-report questionnaire, including the registration of the overall experience of each session, using a Visual Analogue Scale (VAS) after each session going form "very unpleasant" to "very pleasant".

  6. feasibility and acceptability of the HRV-BF and SPB interventions.

    Time frame: During the intervention phase (between week 5 and week 10) and during the once per week guided intervention sessions at week 5, 6 and 7.

    The investigators will explore how participants experience the guided breathing protocols, including their, safety. This aspect will be assessed though self-report questionnaires, including the registration of adverse events and mild negative reactions.

  7. feasibility and acceptability of the HRV-BF and SPB interventions.

    Time frame: During the guided intervention sessions at week 5, 6 and 7.

    The investigators will explore how participants experience the guided breathing protocols, including their, safety. This aspect will be assessed though through observations and contact with the investigator during the guided intervention sessions

  8. feasibility and acceptability of the HRV-BF and SPB interventions.

    Time frame: During the intervention phase (between week 5 and week 10) and during the once per week guided intervention sessions at week 5, 6 and 7.

    The investigators will explore how participants experience the guided breathing protocols, including their, safety. This aspect will be assessed though the registration of adverse events and mild negative reactions.

  9. feasibility and acceptability of the HRV-BF and SPB interventions.

    Time frame: At time point 3 (week 15) during the follow-up assessment

    The investigators will explore how participants experience the guided breathing protocols, including their acceptability, safety, usability and adaptability to daily life. These aspects will be assessed through in-depth interviews. The interview guide was developed based on the Theoretical Framework of Acceptability (TFA). This framework allows for a comprehensive exploration of intervention acceptability through seven key constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy).

  10. Feasibility and acceptability of the HRV-BF and SPB interventions.

    Time frame: At time point 3 (week 15) during the follow-up assessment

    The investigators will explore how participants experience the guided breathing protocols, including their usability. This aspect will be assessed through a self-report questionnaire, namely: the System Usability Scale (SUS), which will provide insight into the usability of the digitally delivered home-based training. Each item will be scored on a five-point Likert scale ranging from "strongly disagree" to "strongly agree. The item scores are summed to calculate the total SUS score, which ranges from 0 to 100, representing the overall system usability. Overall scores from 0 to 50 indicate "not acceptable," 51 to 70 indicate marginal level of usability, and 71 to 100 indicate "acceptable" levels of usability.

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Meers

CONTACT

[email protected]

+32 479976950

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: PEACE-A

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 20, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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