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Generalised Anxiety DisorderNCT05278455

Self-help Lifestyle Medicine for Generalized Anxiety Symptoms

A study testing Lifestyle Medicine in people with Generalised Anxiety Disorder, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Generalised Anxiety Disorder
What is being tested?
Lifestyle Medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteHong Kong
Study dates
Jun 2022to Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Vincent Wing-Hei Wong, PhD student in Psychology contact

+852 39436575

vincentwongWH@link.cuhk.edu.hk

Hong Kong1 site

  • The Chinese University of Hong Kong

    Shatin

Other trials in Hong Kong

About this study

Official title: Smartphone-Delivered Lifestyle Medicine Intervention for Generalized Anxiety Symptoms: A Randomized Controlled Trial

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.

Being tested
Lifestyle Medicine
Keywords
Generalised anxiety disorder, Smartphone-based, Multicomponent lifestyle medicine intervention, Self-help, Randomised controlled trial
Medical subject headings
Generalized Anxiety Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle MedicineBehavioural

    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.

Study groups in NCT05278455
Study groupRoleWhat they receive
Lifestyle Medicine GroupExperimentalLifestyle 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.
Receives: Behavioral: Lifestyle Medicine
Waitlist Control GroupNo interventionThe waitlist control group will receive access to the lifestyle medicine app at the end of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (8)

  1. Change in the Patient Health Questionnaire (PHQ-9)

    PHQ-9 is a nine-item scale for assessing the level of depressive symptoms in the past two weeks. This four-point Likert scale is rated from 0 (not at all) to 3 (almost every day), and the cut off scores on the sum of each item will be the standard to differentiate the depressive level (5, 10, 15, 20 correspond to mild, moderate, moderately severe and severe respectively)

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

  2. Change in the Insomnia Severity Index (ISI)

    ISI is a seven-item scale for measuring the severity of sleep disturbance. This five-point Likert scale is rated from 0 to 4 for each item, and a higher total score indicates the more severe of the insomnia condition (8, 15, 22 correspond to subthreshold insomnia, moderate clinical insomnia and severe clinical insomnia respectively).

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

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

    SF-6D is a single index and preference-based questionnaire for measuring individual's quality of lives in the following six domains, including physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.

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

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

    HPLP-II is a 52-item questionnaire for measuring the present lifestyle or personal habits with six sub-scale domains, including health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management. The inventory uses a four-point Likert scale, from 1 (never) to 4 (routinely), to evaluate the frequency of items asked to the participants.

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

  5. Change in the Sheehan Disability Scale (SDS)

    SDS is a three-item, self-reported 10-point visual analog scale on measuring one's severity level of impairment on three dimensions, including work/school, social life, and family life.

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

  6. Change in the Credibility-Expectancy Questionnaire (CEQ)

    CEQ is a self-reported 6-item inventory for assessing one's attitude towards the credibility and expectancy of the intervention contents.

    Measured: Baseline and immediate post-intervention

  7. Change in the Treatment Acceptance Questionnaire (TAQ)

    TAQ is a self-reported, six-item questionnaire that is rated by a seven-point Likert scale from 1 to 7, and it aims at evaluating the clients' attitude toward the treatment sessions by six domains, including acceptability, ethics, effectiveness, negative side effects, the therapist's knowledge, and the therapist's trustworthiness.

    Measured: Baseline and immediate post-intervention

  8. Change in the International Physical Activities Questionnaire-Chinese version (IPAQ-C)

    IPAQ-C is a 5-item questionnaire that measures the amount of sitting time, walking time, and moderate and vigorous exercise during the last 7 days. Different exercise types are categorized and rated as different metabolic equivalent tasks, while a higher score of the sum of total items represents a higher intense of activity level.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2022
  2. Study startJun 2022 (estimated)
  3. Primary completionDec 2022 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05278455
Sponsor's protocol ID
PSY020
Status last verified
Mar 2022
First submitted
4 Mar 2022
Last updated
14 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Medicine in people with Generalised Anxiety Disorder, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vincent Wing-Hei Wong, PhD student in Psychology (+852 39436575, vincentwongWH@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Generalized Anxiety Disorder-7 (GAD-7) (time frame: Baseline, immediate post-intervention, and 3-month post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05278455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.

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