DepressionNCT05716464
The Effect of Group-based Lifestyle Medicine Intervention and CBT on Depressive Symptoms
A study testing Lifestyle medicine intervention and Cognitive-behavioral therapy for depression (CBT-D) in people with Depression, run by Chinese University of Hong Kong.
Trial summary
The objective of this randomized controlled trial is to evaluate and compare the efficacy of group-based lifestyle medicine intervention and cognitive-behavioral therapy for depression (CBT-D) for Chinese adults with depressive symptoms. 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 intervention and Cognitive-behavioral therapy for depression (CBT-D)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Aug 2024
- 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
- Chinese adults reside in Hong Kong;
- Aged between 18 to 65 years;
- Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10, indicating at least moderate level of depressive symptoms;
- Able to read and understand Chinese/Cantonese and are fluent in Cantonese;
- Willing to provide informed consent and comply with the trial protocol.
Who cannot join
- Received psychotherapy for depression in the past 6 months;
- A change in psychotropic drugs that target depression within 2 weeks before the baseline assessment;
- A PHQ-9 question 9 score 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 intervention study that may potentially improve mental health;
- Self-disclosure of any psychiatric, medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise is not recommended by physicians);
- Pregnancy;
- Hospitalization.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Group-based Lifestyle Medicine Intervention and Cognitive Behavioural Therapy on Depressive Symptoms: A Pilot Randomised Controlled Trial
The objective of this randomized controlled trial is to evaluate and compare the efficacy of group-based lifestyle medicine intervention and cognitive-behavioral therapy for depression (CBT-D) for Chinese adults with depressive symptoms.
Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 40 eligible participants aged between 18 to 65 with depression (Patient Health Questionnaire-9 [PHQ-9] ≥ 10) will be randomly assigned to the Lifestyle Medicine group (LM group), or the CBT-D group in a ratio of 1:1. Participants in both groups will receive interventions either through lifestyle medicine intervention or CBT-D group therapy for 6 consecutive weeks. The outcomes of interest will include depressive, anxiety, and insomnia symptoms, quality of life, functional impairment, and health-promoting behaviours at baseline (week 0), immediate (week 7) and 3-month post-intervention assessments (week 19). Treatment credibility and acceptability will be collected before and immediately after treatment.
- Conditions
- Depression
- Being tested
- Lifestyle medicine intervention, Cognitive-behavioral therapy for depression (CBT-D)
- Keywords
- Depression, Lifestyle medicine, Cognitive-behavioral therapy for depression, Randomised controlled trial
- 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 interventionBehavioural
The lifestyle medicine intervention includes six weekly sessions (i.e., participants will receive the intervention once per week) that are related to the following topics: (a) lifestyle psychoeducation, (b) physical activity, (c) dietary recommendation, (d) stress management, (e) sleep management and (f) motivation and goal-setting techniques. Each topic will be delivered during each face-to-face session and the duration of each session will be around 120 minutes.
Cognitive-behavioral therapy for depression (CBT-D)Behavioural
The group-based CBT-D therapy includes six weekly sessions (i.e., participants will attend one 120-minute, face-to-face group therapy per week, and will be asked to practice taught-skills every day, for 42 days) that are related to the following topics: (a) psychoeducation, (b) cognitive restructuring, (c) behavioral activation, (d) self-care and relapse prevention.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle medicine intervention (LM) | Experimental | Participants in the LM group will receive a 6-week group-based lifestyle medicine intervention. Receives: Behavioral: Lifestyle medicine intervention |
| Cognitive-behavioral therapy for depression (CBT-D) | Experimental | Participants in the CBT-D group will receive a 6-week group-based cognitive-behavioral therapy for depression. Receives: Behavioral: Cognitive-behavioral therapy for depression (CBT-D) |
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-treatment, and 12-week follow-up
Secondary outcomes (8)
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-treatment, and 12-week follow-up
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-treatment, 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, immediate post-treatment, 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, immediate post-treatment, 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, immediate post-treatment, and 12-week follow-up
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-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 a short form of the IPAQ-C. The 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?"; "During the last 7 days, on how many days did you do at least 10 minutes moderate physical activity/vigorous physical activity/walking?"; "How much time did you usually spend doing the moderate physical activity /vigorous physical activity/walking on one of those days?"; and "How much time did you usually spend engaging in physical activity while seated and standing on one of those days?"
Measured: Baseline, immediate post-treatment, and 12-week follow-up
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-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (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
- 40 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
- NCT05716464
- Sponsor's protocol ID
- PSY029
- Status last verified
- Jan 2023
- First submitted
- 28 Jan 2023
- Last updated
- 8 Feb 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Group-based Lifestyle Medicine Intervention and Cognitive Behavioural Therapy on Depressive Symptoms: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05716464
- Acronym / sponsor ID
- PSY029
- Conditions
- Depression
- Keywords
- Depression, Lifestyle medicine, Cognitive-behavioral therapy for depression, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 8 Feb 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 randomized controlled trial is to evaluate and compare the efficacy of group-based lifestyle medicine intervention and cognitive-behavioral therapy for depression (CBT-D) for Chinese adults with depressive symptoms.
Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 40 eligible participants aged between 18 to 65 with depression (Patient Health Questionnaire-9 [PHQ-9] ≥ 10) will be randomly assigned to the Lifestyle Medicine group (LM group), or the CBT-D group in a ratio of 1:1. Participants in both groups will receive interventions either through lifestyle medicine intervention or CBT-D group therapy for 6 consecutive weeks. The outcomes of interest will include depressive, anxiety, and insomnia symptoms, quality of life, functional impairment, and health-promoting behaviours at baseline (week 0), immediate (week 7) and 3-month post-intervention assessments (week 19). Treatment credibility and acceptability will be collected before and immediately after treatment.
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 intervention (LM) | Experimental | Behavioral: Lifestyle medicine interventionParticipants in the LM group will receive a 6-week group-based lifestyle medicine intervention. |
| Cognitive-behavioral therapy for depression (CBT-D) | Experimental | Behavioral: Cognitive-behavioral therapy for depression (CBT-D)Participants in the CBT-D group will receive a 6-week group-based cognitive-behavioral therapy for depression. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese adults reside in Hong Kong;
- Aged between 18 to 65 years;
- Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10, indicating at least moderate level of depressive symptoms;
- Able to read and understand Chinese/Cantonese and are fluent in Cantonese;
- Willing to provide informed consent and comply with the trial protocol.
Key exclusion criteria (7 listed)
- Received psychotherapy for depression in the past 6 months;
- A change in psychotropic drugs that target depression within 2 weeks before the baseline assessment;
- A PHQ-9 question 9 score 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 intervention study that may potentially improve mental health;
- Self-disclosure of any psychiatric, medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise is not recommended 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 interventionThe lifestyle medicine intervention includes six weekly sessions (i.e., participants will receive the intervention once per week) that are related to the following topics: (a) lifestyle psychoeducation, (b) physical activity, (c) dietary recommendation, (d) stress management, (e) sleep management and (f) motivation and goal-setting techniques. Each topic will be delivered during each face-to-face session and the duration of each session will be around 120 minutes. | Behavioural | Lifestyle medicine intervention (LM) |
| Cognitive-behavioral therapy for depression (CBT-D)The group-based CBT-D therapy includes six weekly sessions (i.e., participants will attend one 120-minute, face-to-face group therapy per week, and will be asked to practice taught-skills every day, for 42 days) that are related to the following topics: (a) psychoeducation, (b) cognitive restructuring, (c) behavioral activation, (d) self-care and relapse prevention. | Behavioural | Cognitive-behavioral therapy for depression (CBT-D) |
Primary outcome
Change in the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, immediate post-treatment, and 12-week follow-up
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).
8 secondary outcomes
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Time frame: Baseline, immediate post-treatment, and 12-week follow-up
Change in the Insomnia Severity Index (ISI)
Time frame: Baseline, immediate post-treatment, and 12-week follow-up
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Time frame: Baseline, immediate post-treatment, and 12-week follow-up
Change in the Health-Promoting Lifestyle Profile (HPLP-II)
Time frame: Baseline, immediate post-treatment, and 12-week follow-up
Change in the Sheehan Disability Scale (SDS)
Time frame: Baseline, immediate post-treatment, and 12-week follow-up
Change in the Credibility-Expectancy Questionnaire (CEQ)
Time frame: Baseline and immediate post-treatment
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Time frame: Baseline, immediate post-treatment, and 12-week follow-up
Change in the Treatment Acceptability and Adherence Scale (TAAS)
Time frame: Baseline and immediate post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 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
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle medicine intervention and Cognitive-behavioral therapy for depression (CBT-D) in people with Depression, run by Chinese University of 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Vivian Lai (3943 6575, vivian.lai@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-treatment, 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 8 Feb 2023.