NCT05716464

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

The Effect of Group-based Lifestyle Medicine Intervention and Cognitive Behavioural Therapy on Depressive Symptoms: A Pilot Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-02-08
• Last updated: 2023-02-08