NCT05716464

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Feb 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

January 28, 2023

Last Update Submit

January 28, 2023

Conditions

Depression

Keywords

DepressionLifestyle medicineCognitive-behavioral therapy for depressionRandomised controlled trial

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-treatment, and 12-week follow-up

Secondary Outcomes (8)

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

    Baseline, immediate post-treatment, and 12-week follow-up

  • Change in the Insomnia Severity Index (ISI)

    Baseline, immediate post-treatment, and 12-week follow-up

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

    Baseline, immediate post-treatment, and 12-week follow-up

  • Change in the Health-Promoting Lifestyle Profile (HPLP-II)

    Baseline, immediate post-treatment, and 12-week follow-up

  • Change in the Sheehan Disability Scale (SDS)

    Baseline, immediate post-treatment, and 12-week follow-up

  • +3 more secondary outcomes

Study Arms (2)

Lifestyle medicine intervention (LM)

EXPERIMENTAL

Participants in the LM group will receive a 6-week group-based lifestyle medicine intervention.

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.

Behavioral: Cognitive-behavioral therapy for depression (CBT-D)

Interventions

Lifestyle medicine interventionBEHAVIORAL

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.

Lifestyle medicine intervention (LM)
Cognitive-behavioral therapy for depression (CBT-D)BEHAVIORAL

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.

Cognitive-behavioral therapy for depression (CBT-D)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Fiona Yan-Yee Ho, PhD

    Chinese University of Hong Kong

    STUDY CHAIR

Central Study Contacts

Vivian Lai

CONTACT

3943 6575vivian.lai@link.cuhk.edu.hk

Vincent Wong

CONTACT

3943 6575vincentwongWH@link.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2023

First Posted

February 8, 2023

Study Start

February 1, 2023

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

February 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share