Self-help Lifestyle Medicine for Generalized Anxiety Symptoms

NCT05278455 | Unknown

• 1 other identifier: PSY020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effects of smartphone-based lifestyle medicine for alleviating generalised anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of generalised anxiety disorder ( Cox \& Olatunji, 2016; Dale et al., 2014; Vøllestad et al., 2012), modifying different lifestyle factors simultaneously, for examples, diet, exercise, stress and sleep, may be effective to reduce generalised anxiety symptoms. Recent studies indicate that service users are showing an increasing interest in self-help interventions for common mental disorders because of their accessibility and low cost (Marshall et al., 2021; Weisel et al., 2019). Nonetheless, to date, only limited self-help interventions that target lifestyle medicine for generalised anxiety symptoms are available. This study will be a randomised controlled trial on the effects of a self-help smartphone-based lifestyle medicine intervention for reducing generalised anxiety symptoms in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 50 eligible participants will be randomly assigned to either smartphone-based lifestyle medicine (LM group) or the waitlist control group (WL group) in a ratio of 1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. Participants in the LM group will receive the multicomponent lifestyle medicine intervention via the app for 8 weeks, whilst the WL control group will receive the intervention after trial completion. The primary outcomes will be the level of generalised anxiety symptoms at immediate and 3-month post-intervention assessments; while the secondary outcomes will be the level of depressive symptoms, insomnia symptoms, physical activity, health-related quality of life, functional impairment, health-promoting behaviours, and intervention acceptability at immediate and 3-month post-intervention assessments.

Conditions

Generalised Anxiety Disorder

Keywords

Generalised anxiety disorder; Smartphone-based; Multicomponent lifestyle medicine intervention; Self-help; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in the Generalized Anxiety Disorder-7 (GAD-7)

  GAD-7 is a seven-item scale for assessing the level of generalized anxiety in the past two weeks. It comprises questions related to feelings of anxious and worry in daily lives. This four-point Likert scale is rated from 0 (not at all) to 3 (almost everyday), and the cut off score on the sum of each item will be the standard to differentiate the anxiety level (5, 10, 15 correspond to mild, moderate and severe respectively)

  Baseline, immediate post-intervention, and 3-month post-intervention

Secondary Outcomes (8)

• Change in the Patient Health Questionnaire (PHQ-9)

  Baseline, immediate post-intervention, and 3-month post-intervention

• Change in the Insomnia Severity Index (ISI)

  Baseline, immediate post-intervention, and 3-month post-intervention

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

  Baseline, immediate post-intervention, and 3-month post-intervention

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

  Baseline, immediate post-intervention, and 3-month post-intervention

• Change in the Sheehan Disability Scale (SDS)

  Baseline, immediate post-intervention, and 3-month post-intervention

Study Arms (2)

Lifestyle Medicine Group

EXPERIMENTAL

Lifestyle medicine smartphone app The lifestyle medicine app contains eight weekly modules that cover healthy eating, exercise, stress management, sleep management, lifestyle psychoeducation, and goal setting.

Behavioral: Lifestyle Medicine

Waitlist Control Group

NO INTERVENTION

The waitlist control group will receive access to the lifestyle medicine app at the end of the study.

Interventions

Lifestyle Medicine BEHAVIORAL

A smartphone-delivered application with a series of lifestyle medicine components, including lifestyle psychoeducational, physical activity, dietary recommendations, stress management, sleep management, and motivation and goal-setting techniques.

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 a Generalized Anxiety Disorder-7 (GAD-7) score ≥ 8
• Able to read Chinese and type in Chinese or English
• Have an Internet-enabled mobile device (iOS or Android operating system)
• Willing to provide informed consent and comply with the trial protocol

You may not qualify if:

• Current involvement in psychotherapy or recent changes in medication for anxiety
• A Patient Health Questionnaire-9 (PHQ-9) item 9 score \> 2, indicating a serious level of suicidal risk (referral information to professional mental health services will be provided)
• Self-disclosure of having unsafe health conditions for which physical activity or a change in diet was contraindicated by physicians
• Self-disclosure of a diagnosis of any major psychiatric, medical or neurocognitive disorders that make participation unsuitable or that may interfere with the adherence to the lifestyle modifications

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Vincent Wing-Hei Wong, PhD student in Psychology

CONTACT

+852 39436575; 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: March 4, 2022
• First Posted: March 14, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2023
• Last Updated: March 14, 2022

Record last verified: 2022-03

Locations

HK (1)