The Effect of Group-based Lifestyle Medicine Intervention and CBT on Depressive Symptoms

NCT ID: NCT05716464

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-08-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lifestyle medicine intervention (LM)

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

Group Type: EXPERIMENTAL

Lifestyle medicine intervention

Intervention Type: BEHAVIORAL

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)

Participants in the CBT-D group will receive a 6-week group-based cognitive-behavioral therapy for depression.

Group Type: EXPERIMENTAL

Cognitive-behavioral therapy for depression (CBT-D)

Intervention Type: 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.

Interventions

Lifestyle medicine intervention

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Chinese adults reside in Hong Kong;

2. Aged between 18 to 65 years;

3. Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10, indicating at least moderate level of depressive symptoms;

4. Able to read and understand Chinese/Cantonese and are fluent in Cantonese;

5. Willing to provide informed consent and comply with the trial protocol.

Exclusion Criteria

1. Received psychotherapy for depression in the past 6 months;

2. A change in psychotropic drugs that target depression within 2 weeks before the baseline assessment;

3. 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);

4. Currently participating in another intervention study that may potentially improve mental health;

5. 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);

6. Pregnancy;

7. Hospitalization.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Fiona YY Ho

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fiona Yan-Yee Ho, PhD

Role: STUDY_CHAIR

Chinese University of Hong Kong

Central Contacts

Vivian Lai

Role: CONTACT

vivian.lai@link.cuhk.edu.hk

3943 6575

Vincent Wong

Role: CONTACT

vincentwongWH@link.cuhk.edu.hk

3943 6575

Other Identifiers

PSY029

Identifier Type: -

Identifier Source: org_study_id