Autism, Autism Spectrum Disorder
Conditions
Keywords
Heart rate variability, Stress, Biofeedback, Autism, Movement behavior, Guided breathing exercise, slow paced breathing
Brief summary
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.
Detailed description
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.
Interventions
DEVICEGuided breathing exercise - SPB
Guided breathing exercises are performed at a fixed pace of 6 breaths per minute (SPB) .
DEVICEGuided breathing exercise - HRV-BF
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).
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The researcher plays an active role during the intervention, and participants will be informed about the different interventions provided in both groups.
Intervention model description
The study begins with an assessment at T0, followed by a five-week baseline period. The assessment consist of a physiological measurement and three mental health questionnaires. During the baseline period, all participants will wear an accelerometer to monitor their movement behaviors. The accelerometer will be wrist worn for 7 consecutive days. After this baseline period, participants will be randomly assigned to one of two intervention groups (HRV- biofeedback or slow-paced breathing) and the second assessment will take place at T1. The following intervention period lasts five weeks. During this period, all participants will receive 3 supervised sessions with the researcher, combined with home-based practice. After the intervention period the third assessment will take place at T2. Following the intervention, there will be a five-week no-intervention period for all participants. After this, a follow-up assessment will take place at T3.
Eligibility
Sex/Gender
ALL
Age
16 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiac vagal modulation of heart rate based on resting-state HRV. | 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. |
| Change in cardiac vagal modulation of heart rate based on resting-state HRV | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in mental health indicators | 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. |
| feasibility and acceptability of the HRV-BF and SPB interventions. | 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". |
| Feasibility and acceptability of the HRV-BF and SPB interventions. | 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. |
Countries
Belgium
Contacts
CONTACTEsther Meers
PRINCIPAL_INVESTIGATORTine Van Damme, Prof. dr.
KU Leuven
Outcome results
None listed