Clinical trial NCT05278455: Self-help Lifestyle Medicine for Generalized Anxiety Symptoms
Official title: Smartphone-Delivered Lifestyle Medicine Intervention for Generalized Anxiety Symptoms: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Generalised Anxiety Disorder
Keywords: Generalised anxiety disorder
Smartphone-based
Multicomponent lifestyle medicine intervention
Self-help
Randomised controlled trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, immediate post-intervention, and 3-month post-intervention
Secondary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, immediate post-intervention, and 3-month post-intervention
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: Baseline, immediate post-intervention, and 3-month post-intervention
measure: Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
timeFrame: Baseline, immediate post-intervention, and 3-month post-intervention
measure: Change in the Health-Promoting Lifestyle Profile (HPLP II)
timeFrame: Baseline, immediate post-intervention, and 3-month post-intervention
measure: Change in the Sheehan Disability Scale (SDS)
timeFrame: Baseline, immediate post-intervention, and 3-month post-intervention
measure: Change in the Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Baseline and immediate post-intervention
measure: Change in the Treatment Acceptance Questionnaire (TAQ)
timeFrame: Baseline and immediate post-intervention
measure: Change in the International Physical Activities Questionnaire-Chinese version (IPAQ-C)
timeFrame: Baseline, immediate post-intervention, and 3-month post-intervention
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: