Comparative Efficacy of Self-Help Multicomponent Lifestyle Medicine Intervention and Cognitive Behavioral Therapy for Depressive Symptoms
NCT ID: NCT05692219
Last Updated: 2023-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2023-01-15
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lifestyle medicine
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.
Lifestyle medicine
6 weeks booklet-delivered multicomponent lifestyle medicine intervention
Cognitive behavioural therapy
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.
Cognitive behavioral therapy
6 weeks booklet-delivered self-help cognitive behavioral therapy
Waitlist control
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).
No interventions assigned to this group
Interventions
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Lifestyle medicine
6 weeks booklet-delivered multicomponent lifestyle medicine intervention
Cognitive behavioral therapy
6 weeks booklet-delivered self-help cognitive behavioral therapy
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Fiona YY Ho
Assistant Professor
Principal Investigators
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Fiona Yan-Yee Ho, PhD
Role: STUDY_CHAIR
Chinese University of Hong Kong
Locations
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The Chinese University of Hong Kong
Shatin, , Hong Kong
Countries
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Central Contacts
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Other Identifiers
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PSY027
Identifier Type: -
Identifier Source: org_study_id
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