Comparative Efficacy of Self-Help Multicomponent Lifestyle Medicine Intervention and Cognitive Behavioral Therapy for Depressive Symptoms

NCT05692219 | Unknown

• 1 other identifier: PSY027
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

Lifestyle Medicine; Cognitive Behavioural Therapy; Self-help

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, immediate post-intervention, and 3-month post-intervention

Secondary Outcomes (9)

• Change in The Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  Baseline, immediate post-intervention, and 3-month post-intervention

• Change in the Insomnia Severity Index (ISI)

  Baseline, immediate post-intervention, and 3-month post-intervention

• Change in the Short Form (Six-Dimension) Health Survey (SF-6D)

  Baseline, immediate post-intervention, and 3-month post-intervention

• Change in The Short Multidimensional Inventory Lifestyle Evaluation (SMILE)

  Baseline, immediate post-intervention, and 3-month post-intervention

• Change in the Sheehan Disability Scale (SDS)

  Baseline, immediate post-intervention, and 3-month post-intervention

Study Arms (3)

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.

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.

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).

Interventions

Lifestyle medicine BEHAVIORAL

6 weeks booklet-delivered multicomponent lifestyle medicine intervention

Lifestyle medicine

Cognitive behavioral therapy BEHAVIORAL

6 weeks booklet-delivered self-help cognitive behavioral therapy

Cognitive behavioural therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Fiona Yan-Yee Ho, PhD

  Chinese University of Hong Kong

  STUDY CHAIR

Central Study Contacts

Chak Lung Ho

CONTACT

3943 6575; 1155144488@link.cuhk.edu.hk

Tsz Ning Ku

CONTACT

3943 6575; 1155143619@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: January 15, 2023
• Primary Completion: August 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)