DepressionNCT05692219
Comparative Efficacy of Self-Help Multicomponent Lifestyle Medicine Intervention and Cognitive Behavioral Therapy for Depressive Symptoms
A study testing Lifestyle medicine and Cognitive behavioral therapy in people with Depression, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The objective of this proposed pilot randomized controlled trial is to examine the efficacy of self-help multicomponent lifestyle medicine intervention and cognitive behavioral therapy relative to a wait-list control group for alleviating depressive symptoms among Hong Kong Chinese adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Lifestyle medicine and Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Jan 2023to 31 Dec 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hong Kong residents
- Aged 18 or above
- Able to read Chinese and write in Chinese or English
- Have a Patient Health Questionnaire-9 (PHQ-9) total score of 10 or higher indicating at least moderate level of depressive symptoms
- Willing to provide informed consent and comply with the trial protocol
- Have an Internet-enabled mobile device (iOS or Android operating system) (for data collection purposes)
Who cannot join
- Received psychotherapy for depression and/or insomnia in the past 6 months
- A change in psychotropic drugs or over-the-counter medications that target depression and/or insomnia within 2 weeks before the baseline assessment
- A PHQ-9 item-9 score equal to or higher than 2, indicating a moderate level of suicidal risk that requires active crisis management (referral information to professional mental health services will be provided)
- Currently participating in another interventional study that may potentially improve mental health
- Pregnancy
- Self-disclosure of having unsafe conditions for which physical activity or a change in diet was contraindicated by physicians or other health professionals (e.g., dietitian)
- Self-disclosure of a diagnosis of any major psychiatric, medical, or neurocognitive disorders that make participation unsuitable or interfere with the adherence to the interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Self-Help Multicomponent Lifestyle Medicine Intervention and Cognitive Behavioral Therapy for Depressive Symptoms: A Pilot Randomized Controlled Trial
The objective of this proposed pilot randomized controlled trial is to examine the efficacy of self-help multicomponent lifestyle medicine intervention and cognitive behavioral therapy relative to a wait-list control group for alleviating depressive symptoms among Hong Kong Chinese adults.
Read the detailed description
This study will serve as a pioneering attempt to investigate the comparative efficacy of self-help multicomponent lifestyle medicine intervention and cognitive behavioral therapy for reducing depressive symptoms. The proposed study will pave the way for future intervention development and provide the evidence base for the integration of lifestyle-based interventions into the current treatment model.
Prior to all study procedures, eligible participants will be required to complete an online informed consent via an in-house smartphone application, Longitudinax Pro. Around 90 eligible participants aged 18 or above with a Patient Health Questionnaire-9 total score of 10 or higher will be randomly assigned to either self-help multicomponent lifestyle medicine intervention (LM), self-help CBT (CBT), or the waitlist control group (WL) in a ratio of 1:1:1 by an independent statistician. Participants in the LM and CBT groups will receive a booklet-delivered multicomponent lifestyle medicine intervention and CBT for depressive symptoms, respectively. Both interventions comprise 6 weekly 60-minute sessions and daily homework activities according to instructions in the booklet (details can be found in "Arms and Interventions"). For both LM and CBT groups, a follow-up phone call (approximately 15 minutes) will be made every two weeks to encourage participants to adhere to the intervention. Participants in the WL group will be asked to maintain their typical activities during the trial period, and they will be given access to either the booklet-delivered multicomponent lifestyle medicine intervention or booklet-delivered CBT following the 3-month post-intervention follow-up. The primary outcome of interest will be depressive symptoms. The secondary outcomes will include anxiety symptoms, perceived insomnia severity, health-promoting behaviors, quality of life, functional impairment, and intervention evaluation at immediate post-intervention and 3-month follow-up assessments.
- Conditions
- Depression
- Being tested
- Lifestyle medicine, Cognitive behavioral therapy
- Keywords
- Lifestyle Medicine, Cognitive Behavioural Therapy, Self-help
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle medicineBehavioural
6 weeks booklet-delivered multicomponent lifestyle medicine intervention
Cognitive behavioral therapyBehavioural
6 weeks booklet-delivered self-help cognitive behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle medicine | Experimental | The booklet-delivered multicomponent lifestyle medicine intervention includes six weekly sessions (i.e., participants are anticipated to access the intervention every day for 42 days) that are related to the following topics: (a) lifestyle psychoeducation, (b) exercise, (c) nutritional recommendations, (d) stress management, (e) sleep management, and (f) motivation and goal-setting techniques. Receives: Behavioral: Lifestyle medicine |
| Cognitive behavioural therapy | Active comparator | The booklet-delivered self-help CBT includes six weekly sessions (i.e., participants are anticipated to access the intervention every day for 42 days) that are related to psychoeducation of depression, cognitive behavioural techniques( e.g. behavioral activation, cognitive restructuring), stress management, mindfulness, goal-setting, and/or positive psychology. Receives: Behavioral: Cognitive behavioral therapy |
| Waitlist control | No intervention | Participants in the waitlist control group will be asked to maintain their typical activities during the trial period, and they will be given the lifestyle medicine booklet or CBT booklet based on their preference following the completion of the 3-month follow-up assessment (Week 19). |
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, immediate post-intervention, and 3-month post-intervention
Secondary outcomes (9)
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, immediate post-intervention, and 3-month post-intervention
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, immediate post-intervention, and 3-month post-intervention
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, immediate post-intervention, and 3-month post-intervention
Change in The Short Multidimensional Inventory Lifestyle Evaluation (SMILE)
The SMILE is a 43-item self-report questionnaire designed to measure 7 aspects of lifestyle, which included diet and nutrition (7-item), substance use (4-item), exercise (3-item), stress management (10-item), sleep management (5- item), social support (10-item), and environmental exposures (4-item). Each item is rated on a 4-point Likert scale. The possible response categories of each item are always (4), several days (3), seldom (2), and never (1). For items 3-4, 8-11, 21, 29, and 40-41, they will be reverse scored. The total score of a lifestyle aspect equals the sum of the respected item score, while the overall lifestyle pattern score can be calculated by summing up the 43-item scores. The higher the score, the better the lifestyle pattern.
Measured: Baseline, immediate post-intervention, and 3-month post-intervention
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, immediate post-intervention, and 3-month post-intervention
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 a short form of the IPAQ-C.
Measured: Baseline, immediate post-intervention, and 3-month post-intervention
Change in the Treatment Acceptability and Adherence Scale (TAAS)
TAAS is a self-reported, ten-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 four domains, including acceptability, adherence, drop-out, and distress. Specific wording referencing "anxiety" was changed to refer to "depression".
Measured: Baseline and immediate post-intervention
Change in the Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. Specific wording referencing "anxiety" was changed to refer to "depression".
Measured: Baseline and immediate post-intervention
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 posted20 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (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
- None (open label)
- 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
- Investigators
- Fiona Yan-Yee Ho, PhD, Study chair, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692219
- Sponsor's protocol ID
- PSY027
- Status last verified
- Jan 2023
- First submitted
- 11 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Self-Help Multicomponent Lifestyle Medicine Intervention and Cognitive Behavioral Therapy for Depressive Symptoms: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05692219
- Acronym / sponsor ID
- PSY027
- Conditions
- Depression
- Keywords
- Lifestyle Medicine, Cognitive Behavioural Therapy, Self-help
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Jan 2023 (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.
The objective of this proposed pilot randomized controlled trial is to examine the efficacy of self-help multicomponent lifestyle medicine intervention and cognitive behavioral therapy relative to a wait-list control group for alleviating depressive symptoms among Hong Kong Chinese adults.
Detailed description
This study will serve as a pioneering attempt to investigate the comparative efficacy of self-help multicomponent lifestyle medicine intervention and cognitive behavioral therapy for reducing depressive symptoms. The proposed study will pave the way for future intervention development and provide the evidence base for the integration of lifestyle-based interventions into the current treatment model.
Prior to all study procedures, eligible participants will be required to complete an online informed consent via an in-house smartphone application, Longitudinax Pro. Around 90 eligible participants aged 18 or above with a Patient Health Questionnaire-9 total score of 10 or higher will be randomly assigned to either self-help multicomponent lifestyle medicine intervention (LM), self-help CBT (CBT), or the waitlist control group (WL) in a ratio of 1:1:1 by an independent statistician. Participants in the LM and CBT groups will receive a booklet-delivered multicomponent lifestyle medicine intervention and CBT for depressive symptoms, respectively. Both interventions comprise 6 weekly 60-minute sessions and daily homework activities according to instructions in the booklet (details can be found in "Arms and Interventions"). For both LM and CBT groups, a follow-up phone call (approximately 15 minutes) will be made every two weeks to encourage participants to adhere to the intervention. Participants in the WL group will be asked to maintain their typical activities during the trial period, and they will be given access to either the booklet-delivered multicomponent lifestyle medicine intervention or booklet-delivered CBT following the 3-month post-intervention follow-up. The primary outcome of interest will be depressive symptoms. The secondary outcomes will include anxiety symptoms, perceived insomnia severity, health-promoting behaviors, quality of life, functional impairment, and intervention evaluation at immediate post-intervention and 3-month follow-up assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifestyle medicine | Experimental | Behavioral: Lifestyle medicineThe booklet-delivered multicomponent lifestyle medicine intervention includes six weekly sessions (i.e., participants are anticipated to access the intervention every day for 42 days) that are related to the following topics: (a) lifestyle psychoeducation, (b) exercise, (c) nutritional recommendations, (d) stress management, (e) sleep management, and (f) motivation and goal-setting techniques. |
| Cognitive behavioural therapy | Active comparator | Behavioral: Cognitive behavioral therapyThe booklet-delivered self-help CBT includes six weekly sessions (i.e., participants are anticipated to access the intervention every day for 42 days) that are related to psychoeducation of depression, cognitive behavioural techniques( e.g. behavioral activation, cognitive restructuring), stress management, mindfulness, goal-setting, and/or positive psychology. |
| Waitlist control | No intervention | –Participants in the waitlist control group will be asked to maintain their typical activities during the trial period, and they will be given the lifestyle medicine booklet or CBT booklet based on their preference following the completion of the 3-month follow-up assessment (Week 19). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Hong Kong residents
- Aged 18 or above
- Able to read Chinese and write in Chinese or English
- Have a Patient Health Questionnaire-9 (PHQ-9) total score of 10 or higher indicating at least moderate level of depressive symptoms
- Willing to provide informed consent and comply with the trial protocol
Key exclusion criteria (7 listed)
- Received psychotherapy for depression and/or insomnia in the past 6 months
- A change in psychotropic drugs or over-the-counter medications that target depression and/or insomnia within 2 weeks before the baseline assessment
- A PHQ-9 item-9 score equal to or higher than 2, indicating a moderate level of suicidal risk that requires active crisis management (referral information to professional mental health services will be provided)
- Currently participating in another interventional study that may potentially improve mental health
- Pregnancy
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 medicine6 weeks booklet-delivered multicomponent lifestyle medicine intervention | Behavioural | Lifestyle medicine |
| Cognitive behavioral therapy6 weeks booklet-delivered self-help cognitive behavioral therapy | Behavioural | Cognitive behavioural therapy |
Primary outcome
Change in The Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, immediate post-intervention, and 3-month post-intervention
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).
9 secondary outcomes
Change in The Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: Baseline, immediate post-intervention, and 3-month post-intervention
Change in the Insomnia Severity Index (ISI)
Time frame: Baseline, immediate post-intervention, and 3-month post-intervention
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Time frame: Baseline, immediate post-intervention, and 3-month post-intervention
Change in The Short Multidimensional Inventory Lifestyle Evaluation (SMILE)
Time frame: Baseline, immediate post-intervention, and 3-month post-intervention
Change in the Sheehan Disability Scale (SDS)
Time frame: Baseline, immediate post-intervention, and 3-month post-intervention
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Time frame: Baseline, immediate post-intervention, and 3-month post-intervention
Change in the Treatment Acceptability and Adherence Scale (TAAS)
Time frame: Baseline and immediate post-intervention
Change in the Credibility-Expectancy Questionnaire (CEQ)
Time frame: Baseline and immediate post-intervention
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 20 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Fiona Yan-Yee Ho, PhD study chair
Chinese University of Hong Kong
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 and Cognitive behavioral therapy 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 6 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 20 Jan 2023. 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 Chak Lung Ho (3943 6575, 1155144488@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 Patient Health Questionnaire (PHQ-9) (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?
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 20 Jan 2023.