Self-help Lifestyle Medicine for Generalized Anxiety Symptoms

NCT ID: NCT05278455

Last Updated: 2022-03-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-09-30

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

Study Design

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

Study Groups

Lifestyle Medicine Group

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.

Group Type: EXPERIMENTAL

Lifestyle Medicine

Intervention Type: 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.

Waitlist Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle Medicine

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• 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, PhD student in Psychology

Role: CONTACT

vincentwongWH@link.cuhk.edu.hk

+852 39436575

Other Identifiers

PSY020

Identifier Type: -

Identifier Source: org_study_id