DepressionNCT05086913
Self-help Lifestyle Medicine App and Booklets for Depression
A study testing Lifestyle medicine smartphone booklets and Lifestyle medicine smartphone app in people with Depression, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to compare self-help lifestyle medicine (LM) delivered by a smartphone app and booklets in managing depressive symptoms in a Chinese population. This study is a randomised controlled trial. First, informed consent will be obtained from potential participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Lifestyle medicine smartphone booklets and Lifestyle medicine smartphone app
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2021to Dec 2022
- 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
- Participants with elevated depressive symptoms as defined by PHQ-9 score 10 or above
- Hong Kong residents
- Aged 18 or above
- Able to read Chinese and type in Chinese or English
- Have an Internet-enabled mobile device (iOS or Android operating system)
Who cannot join
- Pregnancy;
- Using medication or psychotherapy for depression;
- Currently participating in other psychological intervention studies;
- Cognitive impairment;
- Having unsafe conditions and are not recommended for physical activity or a change in diet by physicians;
- Self-disclosure of any major psychiatric, medical, or neurocognitive disorders that make participation unsuitable or may interfere with the adherence of the lifestyle modification;
- Any suicidal ideation (scoring above 2 in item 9 in BDI-II) Participants with any urgent health necessity were excluded and referred.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong
Shatin
Fiona Ho, +852 39436575, pmhlab@cuhk.edu.hk
About this study
Official title: A Comparison of Self-help Lifestyle Modification Delivered by a Smartphone App and Booklets in Managing Depressive Symptoms: a Pilot Randomised Controlled Trial.
This study aims to compare self-help lifestyle medicine (LM) delivered by a smartphone app and booklets in managing depressive symptoms in a Chinese population.
This study is a randomised controlled trial. First, informed consent will be obtained from potential participants. Around 90 eligible participants will be randomly assigned to either the LM app group, the LM booklet group, and the waitlist control group, in a ratio of 1:1:1. The app group will receive an app to facilitate lifestyle modification such as video demonstrations of physical activity, diet recommendations, stress and sleep management. The booklet group will receive 8 LM booklets with identical content with the LM app. The waitlist control group will receive access to the app and booklets at the end of the study. The whole intervention lasts 8 weeks. Participants will also receive 2 messages per week from the researcher to check and prompt motivation and adherence. Participants will complete assessment before, immediately after intervention, at one month and 12-week follow up.
Read the detailed description
As lifestyle plays an important role in the pathogenesis of depression, lifestyle medicine (LM) emerges as a new way to alleviate depressive symptoms (Sarris \& O'Neil, 2016). Booklets have been shown as an inexpensive and effective delivery modality of lifestyle modification among individuals with physical conditions (Wong, Chair \& Wong, 2017). Meanwhile, a recent meta-analysis supports the efficacy of mobile applications in improving depressive symptoms (Linardon, Cujipers, Carlbring, Messer \& Fuller-Tyszkiewicz, 2019). Notably, the efficacy of lifestyle intervention using booklets and app have not been compared. This pilot study can inform the field about the efficacy of lifestyle intervention using two self-help delivery modalities and offer new ways to better managing depressive symptoms.
This study will be a randomised controlled trial comparing self-help LM delivered by a smartphone app and booklets in improving depression. For a pilot study, a sample size of 12 per group is recommended (Julious, 2005). Considering an estimation of 20% attrition at the three assessment time points, the final sample size is 90, with 30 participants in each group.
The LM booklet group will receive a pocket size 6-page booklet weekly that covers 8 lifestyle medicine themes including stress, relaxation, diet, exercise, sleep hygiene, worry management, mindfulness, and positive psychology. Exercises based on cognitive behavioural therapy and guidance to set and meet short term and long-term goals are featured in the booklets. The booklet series is reviewed by a panel of experts including clinical psychologists, psychiatrists, dietitians, physical trainers, and traditional Chinese Medicine practitioners. The app group will receive access to a mobile app that offers 8 modules with identical content as the wellness booklets, in addition to videos, relaxation, exercise and cooking demonstrations, daily challenges and record of goals. The waitlist control group will receive access to the app and booklets at the end of the study.
- Conditions
- Depression
- Being tested
- Lifestyle medicine smartphone booklets, Lifestyle medicine smartphone app, Waitlist control
- Keywords
- Depression, Self-help, Lifestyle Medicine, Well-being
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle medicine smartphone bookletsOther
Participants will receive a pocket size 6-page booklet weekly over 8 weeks that covers 8 lifestyle medicine, mental health and CBT themes including stress, relaxation, diet, exercise, sleep hygiene, worry management, mindfulness, and positive psychology, and guides participants to set and meet short term and long-term goals.
Lifestyle medicine smartphone appOther
The lifestyle medicine app offers 8 modules with identical content as the wellness booklets, in addition to videos, relaxation, exercise and cooking demonstrations, daily challenges, record of goals, and ecological momentary assessments of diet, physical activity, sleep, stress and mood.
Waitlist controlOther
The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle medicine smartphone app | Experimental | The app group will receive an app to facilitate lifestyle modification such as video demonstrations of physical activity, diet recommendations, stress and sleep management. Receives: Other: Lifestyle medicine smartphone app |
| lifestyle medicine booklets | Experimental | The booklet group will receive 8 lifestyle medicine and psychoeducation booklets with identical content with the lifestyle medicine app. Receives: Other: Lifestyle medicine smartphone booklets |
| waitlist control | Sham comparator | The waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study. Receives: Other: Waitlist control |
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 20-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-intervention, 4-week and 12-week follow-up
Secondary outcomes (9)
Self-developed survey
A 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
Change in the World Health Organization 5-item Well-Being Index
This is a 5-item measure of global subjective well-being. The internal consistency prior to treatment was 0.86.
Measured: baseline, immediately post-intervention, 4-week and 12-week follow-up
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-intervention, 4-week and 12-week follow-up
Change in the Perceived Stress Scale (PSS)
The PSS measures the perceived amount of stress experienced over the past month.
Measured: baseline, immediately post-intervention, 4-week and 12-week follow-up
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-intervention, 4-week and 12-week follow-up
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-intervention, 4-week and 12-week follow-up
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-intervention, 4-week and 12-week follow-up
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 the short form of the International Physical Activity Questionnaire - Chinese version. 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-intervention, 4-week and 12-week follow-up
Change in the Insomnia Severity Index (ISI)
The 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-intervention, 4-week and 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study startNov 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- 90 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
- NCT05086913
- Sponsor's protocol ID
- PSY017
- Status last verified
- Nov 2021
- First submitted
- 9 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Self-help Lifestyle Modification Delivered by a Smartphone App and Booklets in Managing Depressive Symptoms: a Pilot Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT05086913
- Acronym / sponsor ID
- PSY017
- Conditions
- Depression
- Keywords
- Depression, Self-help, Lifestyle Medicine, Well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Oct 2021 (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 aims to compare self-help lifestyle medicine (LM) delivered by a smartphone app and booklets in managing depressive symptoms in a Chinese population.
This study is a randomised controlled trial. First, informed consent will be obtained from potential participants. Around 90 eligible participants will be randomly assigned to either the LM app group, the LM booklet group, and the waitlist control group, in a ratio of 1:1:1. The app group will receive an app to facilitate lifestyle modification such as video demonstrations of physical activity, diet recommendations, stress and sleep management. The booklet group will receive 8 LM booklets with identical content with the LM app. The waitlist control group will receive access to the app and booklets at the end of the study. The whole intervention lasts 8 weeks. Participants will also receive 2 messages per week from the researcher to check and prompt motivation and adherence. Participants will complete assessment before, immediately after intervention, at one month and 12-week follow up.
Detailed description
As lifestyle plays an important role in the pathogenesis of depression, lifestyle medicine (LM) emerges as a new way to alleviate depressive symptoms (Sarris \& O'Neil, 2016). Booklets have been shown as an inexpensive and effective delivery modality of lifestyle modification among individuals with physical conditions (Wong, Chair \& Wong, 2017). Meanwhile, a recent meta-analysis supports the efficacy of mobile applications in improving depressive symptoms (Linardon, Cujipers, Carlbring, Messer \& Fuller-Tyszkiewicz, 2019). Notably, the efficacy of lifestyle intervention using booklets and app have not been compared. This pilot study can inform the field about the efficacy of lifestyle intervention using two self-help delivery modalities and offer new ways to better managing depressive symptoms.
This study will be a randomised controlled trial comparing self-help LM delivered by a smartphone app and booklets in improving depression. For a pilot study, a sample size of 12 per group is recommended (Julious, 2005). Considering an estimation of 20% attrition at the three assessment time points, the final sample size is 90, with 30 participants in each group.
The LM booklet group will receive a pocket size 6-page booklet weekly that covers 8 lifestyle medicine themes including stress, relaxation, diet, exercise, sleep hygiene, worry management, mindfulness, and positive psychology. Exercises based on cognitive behavioural therapy and guidance to set and meet short term and long-term goals are featured in the booklets. The booklet series is reviewed by a panel of experts including clinical psychologists, psychiatrists, dietitians, physical trainers, and traditional Chinese Medicine practitioners. The app group will receive access to a mobile app that offers 8 modules with identical content as the wellness booklets, in addition to videos, relaxation, exercise and cooking demonstrations, daily challenges and record of goals. The waitlist control group will receive access to the app and booklets at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifestyle medicine smartphone app | Experimental | Other: Lifestyle medicine smartphone appThe app group will receive an app to facilitate lifestyle modification such as video demonstrations of physical activity, diet recommendations, stress and sleep management. |
| lifestyle medicine booklets | Experimental | Other: Lifestyle medicine smartphone bookletsThe booklet group will receive 8 lifestyle medicine and psychoeducation booklets with identical content with the lifestyle medicine app. |
| waitlist control | Sham comparator | Other: Waitlist controlThe waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with elevated depressive symptoms as defined by PHQ-9 score 10 or above
- Hong Kong residents
- Aged 18 or above
- Able to read Chinese and type in Chinese or English
- Have an Internet-enabled mobile device (iOS or Android operating system)
Key exclusion criteria (7 listed)
- Pregnancy;
- Using medication or psychotherapy for depression;
- Currently participating in other psychological intervention studies;
- Cognitive impairment;
- 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 medicine smartphone bookletsParticipants will receive a pocket size 6-page booklet weekly over 8 weeks that covers 8 lifestyle medicine, mental health and CBT themes including stress, relaxation, diet, exercise, sleep hygiene, worry management, mindfulness, and positive psychology, and guides participants to set and meet short term and long-term goals. | Other | lifestyle medicine booklets |
| Lifestyle medicine smartphone appThe lifestyle medicine app offers 8 modules with identical content as the wellness booklets, in addition to videos, relaxation, exercise and cooking demonstrations, daily challenges, record of goals, and ecological momentary assessments of diet, physical activity, sleep, stress and mood. | Other | Lifestyle medicine smartphone app |
| Waitlist controlThe waitlist control group will receive access to the lifestyle medicine app and booklets at the end of the study. | Other | waitlist control |
Primary outcome
Change in the Patient Health Questionnaire (PHQ-9)
Time frame: baseline, immediately post-intervention, 4-week and 12-week follow-up
The PHQ-9, a 20-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).
9 secondary outcomes
Self-developed survey
Time frame: Baseline
Change in the World Health Organization 5-item Well-Being Index
Time frame: baseline, immediately post-intervention, 4-week and 12-week follow-up
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Time frame: baseline, immediately post-intervention, 4-week and 12-week follow-up
Change in the Perceived Stress Scale (PSS)
Time frame: baseline, immediately post-intervention, 4-week and 12-week follow-up
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: baseline, immediately post-intervention, 4-week and 12-week follow-up
Change in the Sheehan Disability Scale (SDS)
Time frame: baseline, immediately post-intervention, 4-week and 12-week follow-up
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Time frame: baseline, immediately post-intervention, 4-week and 12-week follow-up
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Time frame: baseline, immediately post-intervention, 4-week and 12-week follow-up
Change in the Insomnia Severity Index (ISI)
Time frame: baseline, immediately post-intervention, 4-week and 12-week follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
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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 smartphone booklets and Lifestyle medicine smartphone app in people with Depression, 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 7 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 3 Nov 2021. 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. Some participants in this study may receive a placebo. 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 Chung Yan Chow, Undergraduate (39436575, pmhlab@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 Patient Health Questionnaire (PHQ-9) (time frame: baseline, immediately post-intervention, 4-week and 12-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2021.