Self-help Lifestyle Medicine for Insomnia

NCT ID: NCT04703283

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2021-10-31

Brief Summary

This study will examine the effects of a self-help smartphone-based multi-component lifestyle medicine intervention (LM) for alleviating insomnia symptoms in a Chinese population. Since a range of lifestyle factors are related to the pathogenesis and progression of insomnia, modifying different lifestyle factors simultaneously, such as diet, exercise, stress, and sleep which are empirically supported by previous reviews, may be effective to reduce insomnia symptoms (Reid et al., 2010; Vedaa et al., 2016). Traditional Chinese nutritional values will be integrated into the smartphone application to increase the acceptability towards the intervention. A prevalence study suggested that self-help interventions are preferred due to the potential stigmatization related to mental health interventions and the high cost of mental health services in Hong Kong (Lee, Tsang, & Kwok, 2007). Nonetheless, to date, only limited self-help interventions that target lifestyle medicine for sleep-related problems are available. Through this study, we aimed to promote evidence-based patient care and improve help-seeking behaviors and access to evidence-based lifestyle interventions for insomnia.

Detailed Description

This study will be a randomized controlled trial on the effects of a self-help smartphone-based multi-component lifestyle medicine intervention for reducing insomnia symptoms in the Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Assuming an alpha error of 5%, a beta error rate of 20%, and a between-group effect size of 0.77 for the Insomnia Severity Scale (Ip et al., 2020), the final sample is 28 for both groups. With an estimation of 20% withdrawal, 70 eligible participants will be randomly assigned to either the smartphone-based multi-component lifestyle medicine intervention (LM group) or the waitlist control group (WL group) in a ratio of 1:1.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lifestyle Medicine Group

Lifestyle intervention with components including exercise, diet, stress management, and sleep management

Group Type: EXPERIMENTAL

Lifestyle Medicine

Intervention Type: BEHAVIORAL

Lifestyle intervention with components including exercise, diet, stress management, and sleep management

Waitlist Control Group

Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle Medicine

Lifestyle intervention with components including exercise, diet, stress management, and sleep management

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Hong Kong residents
• Aged ≥ 18 years
• Have an Insomnia Severity Index (ISI) score ≥10, indicating at least sub threshold level of insomnia symptoms are present
• Able to read Chinese and type in Chinese or English
• Have an Internet-enabled mobile device (iOS or Android operating system)
• Are willing to provide informed consent and comply with the trial protocol

Exclusion Criteria

• Current involvement in psychotherapy or unstable medication for sleep, depression, and/or anxiety
• Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk)
• Are having unsafe conditions and are not recommended for exercise or a change in diet by physicians
• Having major psychiatric, medical, or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification
• Other untreated sleep disorders, including narcolepsy, obstructive sleep apnoea (OSA), and restless leg syndrome (RLS)/periodic leg movement disorder (PLMD) based on the cut-off scores (≥ 7 on narcolepsy; ≥ 15 on OSA; ≥ 7 on RLS/PLMD) of individual sections in SLEEP-50
• Shift work, pregnancy, work, family, or other commitments that interfere with regular night-time sleep patterns
• Hospitalization

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Fiona YY Ho

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

Central Contacts

Vincent Wing-Hei Wong

Role: CONTACT

vincentwongwh@link.cuhk.edu.hk

+852 3943 6575

Other Identifiers

PSY012

Identifier Type: -

Identifier Source: org_study_id