Self-help Lifestyle Medicine for Insomnia

NCT04703283 | Unknown

• 1 other identifier: PSY012
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

Insomnia; Lifestyle Medicine; Self-help

Outcome Measures

Primary Outcomes (1)

• Change in the 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, immediately post-intervention, and 1-month post-intervention

Secondary Outcomes (8)

• Change in the Hospital Anxiety and Depression Scale (HADS)

  Baseline, immediately post-intervention, and 1-month post-intervention

• Change in the Short Form (Six-Dimension) Health Survey (SF-6D)

  Baseline, immediately post-intervention, and 1-month post-intervention

• Change in the Health-Promoting Lifestyle Profile (HPLP II)

  Baseline, immediately post-intervention, and 1-month post-intervention

• Change in the Sheehan Disability Scale (SDS)

  Baseline, immediately post-intervention, and 1-month post-intervention

• Change in the Credibility-Expectancy Questionnaire (CEQ)

  Baseline, immediately post-intervention, and 1-month post-intervention

Study Arms (2)

Lifestyle Medicine Group

EXPERIMENTAL

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

Behavioral: Lifestyle Medicine

Waitlist Control Group

NO INTERVENTION

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

Interventions

Lifestyle Medicine BEHAVIORAL

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

Lifestyle Medicine Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

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

Vincent Wing-Hei Wong

CONTACT

+852 3943 6575; vincentwongwh@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: January 7, 2021
• First Posted: January 11, 2021
• Study Start: March 1, 2021
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 11, 2021

Record last verified: 2021-01

Locations

HK (1)