Psychological DistressNCT04295369
Lifestyle Hub Pilot Study
A study testing Lifestyle Medicine in people with Psychological Distress, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study will examine the effects of a smartphone-based lifestyle medicine (LM) for improving psychological well-being in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of common mental disorders (e.g., depression and anxiety), modifying different lifestyle… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Distress
- What is being tested?
- Lifestyle Medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Feb 2020to Jun 2020
- 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
- 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
Who cannot join
- Have a Patient Health Questionnaire (PHQ-9) score ≥ 10
- Have a Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
- Current involvement in psychotherapy or unstable medication for 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 physical activity 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Shatin
Fiona Ho, +852 39436575, pmhlab@cuhk.edu.hk
About this study
Official title: Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Improving Psychological Well-being: A Pilot Randomized Controlled Trial
This study will examine the effects of a smartphone-based lifestyle medicine (LM) for improving psychological well-being in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of common mental disorders (e.g., depression and anxiety), modifying different lifestyle factors simultaneously may be effective to improve our psychological well-being. Chinese dietary recommendations will be integrated into the app to increase the acceptability towards mental health intervention. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for improving psychological well-being.
Read the detailed description
This study will be a randomized controlled trial on the effects of a culturally adapted self-help smartphone-based lifestyle medicine for improving psychological well-being in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 30 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.
- Conditions
- Psychological Distress
- Being tested
- Lifestyle Medicine
- Keywords
- Psychological Well-being, Lifestyle Medicine, Self-help, Depression, Anxiety
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle MedicineBehavioural
Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep, stress management, and Chinese dietary recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Medicine Group | Experimental | Not described Receives: Behavioral: Lifestyle Medicine |
| Waitlist Control Group | No intervention | Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Depression Anxiety Stress Scales-21
DASS-21 is a 21-items scale, comprises of three sub-scales which measures the negative emotional states of depression, anxiety, and stress, over the past week. The DASS is based on a dimensional rather than a categorical conception of psychological disorder, thus it has no direct implications for the allocation of patients to discrete diagnostic categories. However, recommended cutoff scores for conventional severity labels (normal, moderate, severe) are given in the DASS Manual.
Measured: Immediately post-treatment and 1-month post treatment
Secondary outcomes (8)
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.
Measured: Baseline, immediately post-treatment and 1-month post treatment
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
Measured: Baseline, immediately post-treatment and 1-month post treatment
Change in the Health-Promoting Lifestyle Profile (HPLP II)
The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
Measured: Baseline, immediately post-treatment and 1-month post treatment
Change in the Sheehan Disability Scale (SDS)
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life. The participant rates the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 10 point visual analog scale. The numerical ratings of 0-10 can be translated into a percentage, if desired. The 3 items can also be summed into a single dimensional measure of global functional impairment that rages from 0 (unimpaired) to 30 (highly impaired).
Measured: Baseline, immediately post-treatment and 1-month post treatment
Change in the Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Measured: Baseline, immediately post-treatment and 1-month post treatment
Change in the Food Frequency Questionnaires (FFQs)
FFQs is a 18-item scale, including drinks, plant, animal products and cigarette intake, which measures the frequency of food intake over the past three months on a 7-point scale.
Measured: Baseline, immediately post-treatment and 1-month post treatment
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from a short form of the International Physical Activity Questionnaire - Chinese version.
Measured: Baseline, immediately post-treatment and 1-month post treatment
Self-developed survey
The self-developed survey will collect information including demographic information (e.g., age, gender, level of education, working industry, relationship status, and location of residence), substance use, body mass index (BMI), rest-activity pattern, and social rhythms, etc.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start10 Feb 2020
- Primary completionMay 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295369
- Sponsor's protocol ID
- PSY010
- Status last verified
- Mar 2020
- First submitted
- 28 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong VW, Tong JT, Shi NK, Ng CH, Sarris J, Ho FY. Smartphone-delivered multicomponent lifestyle medicine intervention for improving mental health in a nonclinical population: a randomized controlled trial. Front Public Health. 2024 Jan 16;11:1231981. doi: 10.3389/fpubh.2023.1231981. eCollection 2023.
PubMed 38292386
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Improving Psychological Well-being: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04295369
- Acronym / sponsor ID
- PSY010
- Conditions
- Psychological Distress
- Keywords
- Psychological Well-being, Lifestyle Medicine, Self-help, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine the effects of a smartphone-based lifestyle medicine (LM) for improving psychological well-being in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of common mental disorders (e.g., depression and anxiety), modifying different lifestyle factors simultaneously may be effective to improve our psychological well-being. Chinese dietary recommendations will be integrated into the app to increase the acceptability towards mental health intervention. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for improving psychological well-being.
Detailed description
This study will be a randomized controlled trial on the effects of a culturally adapted self-help smartphone-based lifestyle medicine for improving psychological well-being in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 30 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Medicine Group | Experimental | Behavioral: Lifestyle Medicine |
| Waitlist Control Group | No intervention | –Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hong Kong residents
- Aged ≥ 18 years
- 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
Key exclusion criteria (6 listed)
- Have a Patient Health Questionnaire (PHQ-9) score ≥ 10
- Have a Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
- Current involvement in psychotherapy or unstable medication for 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 physical activity or a change in diet by physicians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle MedicineLifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep, stress management, and Chinese dietary recommendations. | Behavioural | Lifestyle Medicine Group |
Primary outcome
Change in the Depression Anxiety Stress Scales-21
Time frame: Immediately post-treatment and 1-month post treatment
DASS-21 is a 21-items scale, comprises of three sub-scales which measures the negative emotional states of depression, anxiety, and stress, over the past week. The DASS is based on a dimensional rather than a categorical conception of psychological disorder, thus it has no direct implications for the allocation of patients to discrete diagnostic categories. However, recommended cutoff scores for conventional severity labels (normal, moderate, severe) are given in the DASS Manual.
8 secondary outcomes
Change in The Insomnia Severity Index (ISI)
Time frame: Baseline, immediately post-treatment and 1-month post treatment
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Time frame: Baseline, immediately post-treatment and 1-month post treatment
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Time frame: Baseline, immediately post-treatment and 1-month post treatment
Change in the Sheehan Disability Scale (SDS)
Time frame: Baseline, immediately post-treatment and 1-month post treatment
Change in the Credibility-Expectancy Questionnaire (CEQ)
Time frame: Baseline, immediately post-treatment and 1-month post treatment
Change in the Food Frequency Questionnaires (FFQs)
Time frame: Baseline, immediately post-treatment and 1-month post treatment
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Time frame: Baseline, immediately post-treatment and 1-month post treatment
Self-developed survey
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Derived from this study: PubMed 38292386Wong VW, Tong JT, Shi NK, Ng CH, Sarris J, Ho FY. Smartphone-delivered multicomponent lifestyle medicine intervention for improving mental health in a nonclinical population: a randomized controlled trial. Front Public Health. 2024 Jan 16;11:1231981. doi: 10.3389/fpubh.2023.1231981. eCollection 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Medicine in people with Psychological Distress, 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 5 inclusion and 6 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 4 Mar 2020. 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 Wong (+852 3943 6575, wingheiwong7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Depression Anxiety Stress Scales-21 (time frame: Immediately post-treatment and 1-month post treatment). 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 NCT04295369, which also lists 1 linked publication.
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 4 Mar 2020.