InsomniaNCT05078268
Heart Rate Variability Biofeedback as Adjunctive Therapy to Self-help CBT-I
A study testing HRV biofeedback training and self-help CBT-I and Self-help CBT-I only in people with Insomnia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study will examine the effect of Heart Rate Variability (HRV) biofeedback as adjunctive therapy to self-help Cognitive Behavioral Therapy on insomnia (CBT-I) in Chinese adult population. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Insomnia
- What is being tested?
- HRV biofeedback training and self-help CBT-I and Self-help CBT-I only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Nov 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hong Kong residents aged 18-59 years
- Cantonese language fluency
- A global Insomnia Severity Index (ISI) score of 10 or higher [A cutoff score of 10 was optimal (86.1% sensitivity and 87.7% specificity) for detecting insomnia cases (Morin, Belleville, Bélanger \& Ivers, 2011)]
- A willingness to provide informed consent and comply with the trial protocol
Who cannot join
- have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to intervention
- previous suicide attempt, severe active suicidal ideation with a specific plan, severe self-harm, active substance abuse, or a history of psychosis.
- having cardiovascular diseases that affect the measure of heart rate variability
- having severe lung infections, central respiratory failure, electrolyte imbalance, fever and other diseases affecting the heart activity
- having with other organic diseases, previous history of arrhythmias (atrial fibrillation and frequent premature beats), hyperthyroidism, history of syncope and autonomic nervous system dysfunction
- have insomnia due to specific medical conditions, side effects of medication intake or other sleep disorders
- change in medication or its dosage 2 weeks before the baseline measurement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of HRV Biofeedback as Adjunctive Therapy to Self-help Cognitive Behavioral Therapy on Insomnia: A Pilot Randomized Controlled Trial
This study will examine the effect of Heart Rate Variability (HRV) biofeedback as adjunctive therapy to self-help Cognitive Behavioral Therapy on insomnia (CBT-I) in Chinese adult population. Heart Rate Variability Biofeedback is a therapy training aiming at increasing heart rate oscillations through real-time feedback and slow breathing training. Several literature has found that HRV biofeedback training is effective in improving HRV and improving sleep quality and sleep efficiency (Gevirtz, 2013; Lin et al., 2019). On the other hand, self-help CBT-I is well-studied in efficacy of improving cognition and behaviors and relieving insomnia (Ho et al., 2014). Rare research study HRV biofeedback as adjunctive therapy to self-help CBT-I (Lehrer, 2017). In the light of this, this study will compare the efficacy of combination of both treatments with that of CBT-I alone, examining whether HRV biofeedback's focus on psychophysiological domain can help self-help CBT-I in more significantly improving HRV and sleep quality.
Read the detailed description
This study will be a pilot randomized controlled trial on the efficacy of HRV biofeedback as adjunctive therapy to self-help CBT-I on insomnia. Potential participants will be recruited from the community through posters, social media sites and/or emails. Prior to all study procedures, the research purpose and data collection procedure will be given to the participants and an informed consent will be obtained from potential participants. Around 44 eligible participants will be randomly assigned to either self-help CBT-I with HRV biofeedback (combined group) or self-help CBT-I only group in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary. Participants in combined group will receive a booklet with content related to both self-help CBT-I and HRV biofeedback based on guidelines of self-help CBT-I and protocol for HRV biofeedback training per week for 6 consecutive weeks. Participants are required to use around 1 hour to read through the content. The combined group is requested to perform the HRV biofeedback practice with a Bluetooth sensor connected with Inner Balance mobile application for around 20 minutes a day, 5-7 days a week and record their practice. Self-help CBT-I only group will receive a booklet with content related to self-help CBT-I only per week for 6 consecutive weeks. Participants are required to use 30 to 40 minutes to read through the content. The combined group and self-help CBT-I only group will complete a set of questionnaires and HRV measurement before the treatment commences, immediately after treatment, and 4 weeks after the treatment sessions are completed.
- Conditions
- Insomnia
- Being tested
- HRV biofeedback training and self-help CBT-I, Self-help CBT-I only
- Keywords
- HRV biofeedback, Self-help CBT-I, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV biofeedback training and self-help CBT-IBehavioural
Participants will receive a booklet with content related to both self-help CBT-I and HRV biofeedback per week for 6 consecutive weeks. Participants are required to use around 1 hour to read through the content and perform the HRV biofeedback practice for around 20 minutes a day, 5-7 days a week and record their practice.
Self-help CBT-I onlyBehavioural
Participants will receive a booklet with content related to self-help CBT-I only per week for 6 consecutive weeks. Participants are required to use 30 to 40 minutes to read through the content.
| Study group | Role | What they receive |
|---|---|---|
| Combined group | Experimental | Participants in combined group will receive both HRV biofeedback training and self-help CBT-I concurrently. Receives: Behavioral: HRV biofeedback training and self-help CBT-I |
| Self-help CBT-I only group | Active comparator | Participants in self-help CBT-I only group will receive self-help CBT-I only. Receives: Behavioral: Self-help CBT-I only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate Variability - Inner Balance
Participants will be instructed to wear an Inner Balance bluetooth sensor connected with a mobile application Inner Balance to practice HRV biofeedback for around 30 minutes a day, 5-7 days a week.
Measured: Baseline, immediate post-treatment, and 4-week follow-up
Change in Insomnia Severity Index (ISI)
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Measured: Baseline, immediate post-treatment, and 4-week follow-up
Change in Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a widely used 24-item scale used to access the sleep quality and disturbances over a 1-month interval. The 19 self-rated questions will be used, which is calculated by a seven-component score from: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction.
Measured: Baseline, immediate post-treatment, and 4-week follow-up
Secondary outcomes (4)
Change in Pre-Sleep Arousal Scale (PSAS)
The Pre-Sleep Arousal Scale (PSAS) includes 16 items scored on a 4-point Likert scale to assess pre-sleep arousal. PSAS includes two sub-scales: physical and cognitive arousals.
Measured: Baseline, immediate post-treatment, and 4-week follow-up
Change in Depression Anxiety Stress Scales (DASS-21)
DASS-21 is a 21-items scales, comprises of three sub-scales which measures the negative emotional states of depression, anxiety, and stress, over the past week.
Measured: Baseline, immediate post-treatment, and 4-week follow-up
Change in The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)
The Multidimensional Assessment of Interoceptive Awareness (MAIA) is an 8-scale state-trait questionnaire with 37 items to measure multiple dimensions of interoception by self-report: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trust.
Measured: Baseline, immediate post-treatment, and 4-week follow-up
Change in Sleep Locus of Control Scale (SLOC)
The Sleep Locus of Control Scale (SLOC) is an 8-item questionnaire designed to evaluate a respondent's sleep-related locus of control - the degree to which an individual attributes his or her experiences of sleep to chance or to internal, intentional causes.
Measured: Baseline, immediate post-treatment, and 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start20 Nov 2021 (estimated)
- Primary completion20 May 2022 (estimated)
- Study completion20 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078268
- Sponsor's protocol ID
- PSY016
- Status last verified
- Nov 2021
- First submitted
- 4 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of HRV Biofeedback as Adjunctive Therapy to Self-help Cognitive Behavioral Therapy on Insomnia: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05078268
- Acronym / sponsor ID
- PSY016
- Conditions
- Insomnia
- Keywords
- HRV biofeedback, Self-help CBT-I, Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Nov 2021 (estimated)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 Jul 2022 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effect of Heart Rate Variability (HRV) biofeedback as adjunctive therapy to self-help Cognitive Behavioral Therapy on insomnia (CBT-I) in Chinese adult population. Heart Rate Variability Biofeedback is a therapy training aiming at increasing heart rate oscillations through real-time feedback and slow breathing training. Several literature has found that HRV biofeedback training is effective in improving HRV and improving sleep quality and sleep efficiency (Gevirtz, 2013; Lin et al., 2019). On the other hand, self-help CBT-I is well-studied in efficacy of improving cognition and behaviors and relieving insomnia (Ho et al., 2014). Rare research study HRV biofeedback as adjunctive therapy to self-help CBT-I (Lehrer, 2017). In the light of this, this study will compare the efficacy of combination of both treatments with that of CBT-I alone, examining whether HRV biofeedback's focus on psychophysiological domain can help self-help CBT-I in more significantly improving HRV and sleep quality.
Detailed description
This study will be a pilot randomized controlled trial on the efficacy of HRV biofeedback as adjunctive therapy to self-help CBT-I on insomnia. Potential participants will be recruited from the community through posters, social media sites and/or emails. Prior to all study procedures, the research purpose and data collection procedure will be given to the participants and an informed consent will be obtained from potential participants. Around 44 eligible participants will be randomly assigned to either self-help CBT-I with HRV biofeedback (combined group) or self-help CBT-I only group in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. No deception is necessary. Participants in combined group will receive a booklet with content related to both self-help CBT-I and HRV biofeedback based on guidelines of self-help CBT-I and protocol for HRV biofeedback training per week for 6 consecutive weeks. Participants are required to use around 1 hour to read through the content. The combined group is requested to perform the HRV biofeedback practice with a Bluetooth sensor connected with Inner Balance mobile application for around 20 minutes a day, 5-7 days a week and record their practice. Self-help CBT-I only group will receive a booklet with content related to self-help CBT-I only per week for 6 consecutive weeks. Participants are required to use 30 to 40 minutes to read through the content. The combined group and self-help CBT-I only group will complete a set of questionnaires and HRV measurement before the treatment commences, immediately after treatment, and 4 weeks after the treatment sessions are completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined group | Experimental | Behavioral: HRV biofeedback training and self-help CBT-IParticipants in combined group will receive both HRV biofeedback training and self-help CBT-I concurrently. |
| Self-help CBT-I only group | Active comparator | Behavioral: Self-help CBT-I onlyParticipants in self-help CBT-I only group will receive self-help CBT-I only. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Hong Kong residents aged 18-59 years
- Cantonese language fluency
- A global Insomnia Severity Index (ISI) score of 10 or higher [A cutoff score of 10 was optimal (86.1% sensitivity and 87.7% specificity) for detecting insomnia cases (Morin, Belleville, Bélanger \& Ivers, 2011)]
- A willingness to provide informed consent and comply with the trial protocol
Key exclusion criteria (7 listed)
- have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to intervention
- previous suicide attempt, severe active suicidal ideation with a specific plan, severe self-harm, active substance abuse, or a history of psychosis.
- having cardiovascular diseases that affect the measure of heart rate variability
- having severe lung infections, central respiratory failure, electrolyte imbalance, fever and other diseases affecting the heart activity
- having with other organic diseases, previous history of arrhythmias (atrial fibrillation and frequent premature beats), hyperthyroidism, history of syncope and autonomic nervous system dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV biofeedback training and self-help CBT-IParticipants will receive a booklet with content related to both self-help CBT-I and HRV biofeedback per week for 6 consecutive weeks. Participants are required to use around 1 hour to read through the content and perform the HRV biofeedback practice for around 20 minutes a day, 5-7 days a week and record their practice. | Behavioural | Combined group |
| Self-help CBT-I onlyParticipants will receive a booklet with content related to self-help CBT-I only per week for 6 consecutive weeks. Participants are required to use 30 to 40 minutes to read through the content. | Behavioural | Self-help CBT-I only group |
Primary outcome
Change in Heart Rate Variability - Inner Balance
Time frame: Baseline, immediate post-treatment, and 4-week follow-up
Participants will be instructed to wear an Inner Balance bluetooth sensor connected with a mobile application Inner Balance to practice HRV biofeedback for around 30 minutes a day, 5-7 days a week.
Change in Insomnia Severity Index (ISI)
Time frame: Baseline, immediate post-treatment, and 4-week follow-up
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, immediate post-treatment, and 4-week follow-up
The PSQI is a widely used 24-item scale used to access the sleep quality and disturbances over a 1-month interval. The 19 self-rated questions will be used, which is calculated by a seven-component score from: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medication, and daytime dysfunction.
4 secondary outcomes
Change in Pre-Sleep Arousal Scale (PSAS)
Time frame: Baseline, immediate post-treatment, and 4-week follow-up
Change in Depression Anxiety Stress Scales (DASS-21)
Time frame: Baseline, immediate post-treatment, and 4-week follow-up
Change in The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)
Time frame: Baseline, immediate post-treatment, and 4-week follow-up
Change in Sleep Locus of Control Scale (SLOC)
Time frame: Baseline, immediate post-treatment, and 4-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV biofeedback training and self-help CBT-I and Self-help CBT-I only in people with Insomnia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Edwin Wong (+852 39436575, 1155125389@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart Rate Variability - Inner Balance (time frame: Baseline, immediate post-treatment, and 4-week follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.