Heart Rate Variability Biofeedback as Adjunctive Therapy to Self-help CBT-I

NCT05078268 | Unknown

• 1 other identifier: PSY016
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Insomnia

Keywords

HRV biofeedback; Self-help CBT-I; Insomnia

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, immediate post-treatment, and 4-week follow-up

Secondary Outcomes (4)

• Change in Pre-Sleep Arousal Scale (PSAS)

  Baseline, immediate post-treatment, and 4-week follow-up

• Change in Depression Anxiety Stress Scales (DASS-21)

  Baseline, immediate post-treatment, and 4-week follow-up

• Change in The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)

  Baseline, immediate post-treatment, and 4-week follow-up

• Change in Sleep Locus of Control Scale (SLOC)

  Baseline, immediate post-treatment, and 4-week follow-up

Study Arms (2)

Combined group

EXPERIMENTAL

Participants in combined group will receive both HRV biofeedback training and self-help CBT-I concurrently.

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.

Behavioral: Self-help CBT-I only

Interventions

HRV biofeedback training and self-help CBT-I BEHAVIORAL

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.

Combined group

Self-help CBT-I only BEHAVIORAL

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.

Self-help CBT-I only group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Edwin Wong

CONTACT

+852 39436575; 1155125389@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 14, 2021
• Study Start: November 20, 2021
• Primary Completion: May 20, 2022
• Study Completion: July 20, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-11

Locations

HK (1)