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

NCT05078268 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-11-03

No results posted yet for this study

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

Interventions

BEHAVIORAL

HRV biofeedback training and self-help CBT-I

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.

BEHAVIORAL

Self-help CBT-I only

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-20
Primary Completion
2022-05-20
Completion
2022-07-20

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078268 on ClinicalTrials.gov