Depression, AnxietyNCT04152850
Self-help Lifestyle Medicine for Depression and Anxiety
A study testing Lifestyle Medicine in people with Depression, Anxiety, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study will examine the effects of smartphone-based lifestyle medicine (LM) for alleviating depressive and anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of depression and anxiety, modifying different lifestyle factors simultaneously, for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- 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
- 124 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Feb 2020to Sep 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong residents
- Aged ≥ 18 years
- Have a Patient Health Questionnaire (PHQ-9) score ≥ 10 or Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
- 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
- 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 Reducing Depressive and Anxiety Symptoms: A Randomized Controlled Trial
This study will examine the effects of smartphone-based lifestyle medicine (LM) for alleviating depressive and anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of depression and anxiety, modifying different lifestyle factors simultaneously, for example, diet, exercise, stress and sleep which are empirically supported by previous reviews, may be effective to reduce depressive and anxiety symptoms. Traditional Chinese medicine concepts will be integrated into the app to increase the acceptability towards mental health treatment. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for depression and anxiety.
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 reducing depressive and anxiety symptoms in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). With an estimation of 30% withdrawal, around 124 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
- Depression, Anxiety
- Being tested
- Lifestyle Medicine
- Keywords
- Depression, Anxiety, Lifestyle Medicine, Self-help
- Medical subject headings
- 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 and Traditional Chinese Medicine
| 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 Patient Health Questionnaire (PHQ-9)
The PHQ-9, a 9-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Measured: Baseline, immediately post-treatment and 1-month post treatment
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
Measured: Baseline, 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.
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) (Lai et al., 2018; Macfarlane, Lee, Ho, Chan, & Chan, 2007)
Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from the short form of the International Physical Activity Questionnaire - Chinese version. The sample questions include: "On a typical weekday in the last 7 days, how many hours per day did you typically spend sitting?"; "On a typical weekend in the last 7 days, how many hours per day did you typically spend sitting?". Participants' engagement in brief strength and stamina-enhancing activity were assessed by asking the number of days they engaged in physical activity while seated and standing in the last seven days.
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 posted5 Nov 2019
- Study start15 Feb 2020
- Primary completionJul 2020 (estimated)
- Study completionSep 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 Depression, AnxietyStudies 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
- 124 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
- NCT04152850
- Sponsor's protocol ID
- PSY009
- Status last verified
- Mar 2020
- First submitted
- 4 Nov 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wong VW, Ho FY, Shi NK, Tong JT, Chung KF, Yeung WF, Ng CH, Oliver G, Sarris J. Smartphone-delivered multicomponent lifestyle medicine intervention for depressive symptoms: A randomized controlled trial. J Consult Clin Psychol. 2021 Dec;89(12):970-984. doi: 10.1037/ccp0000695.
PubMed 35025538
Study at a glance
From the registry record, last updated by the sponsor on 11 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 Reducing Depressive and Anxiety Symptoms: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04152850
- Acronym / sponsor ID
- PSY009
- Conditions
- Depression, Anxiety
- Keywords
- Depression, Anxiety, Lifestyle Medicine, Self-help
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 5 Nov 2019 (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 smartphone-based lifestyle medicine (LM) for alleviating depressive and anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of depression and anxiety, modifying different lifestyle factors simultaneously, for example, diet, exercise, stress and sleep which are empirically supported by previous reviews, may be effective to reduce depressive and anxiety symptoms. Traditional Chinese medicine concepts will be integrated into the app to increase the acceptability towards mental health treatment. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for depression and anxiety.
Detailed description
This study will be a randomized controlled trial on the effects of a culturally adapted self-help smartphone-based lifestyle medicine for reducing depressive and anxiety symptoms in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). With an estimation of 30% withdrawal, around 124 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hong Kong residents
- Aged ≥ 18 years
- Have a Patient Health Questionnaire (PHQ-9) score ≥ 10 or Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
- Able to read Chinese and type in Chinese or English
- Have an Internet-enabled mobile device (iOS or Android operating system)
Key exclusion criteria (4 listed)
- 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
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 and Traditional Chinese Medicine | Behavioural | Lifestyle Medicine Group |
Primary outcome
Change in the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, immediately post-treatment and 1-month post treatment
The PHQ-9, a 9-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: Baseline, immediately post-treatment and 1-month post treatment
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
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) (Lai et al., 2018; Macfarlane, Lee, Ho, Chan, & Chan, 2007)
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 11 Mar 2020.
- Derived from this study: PubMed 35025538Wong VW, Ho FY, Shi NK, Tong JT, Chung KF, Yeung WF, Ng CH, Oliver G, Sarris J. Smartphone-delivered multicomponent lifestyle medicine intervention for depressive symptoms: A randomized controlled trial. J Consult Clin Psychol. 2021 Dec;89(12):970-984. doi: 10.1037/ccp0000695.
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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 Depression, Anxiety, 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 11 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 Patient Health Questionnaire (PHQ-9) (time frame: Baseline, immediately post-treatment and 1-month post treatment). The study lists 2 primary outcomes in all. 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 NCT04152850, 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 11 Mar 2020.