NCT05692219

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

Comparative Efficacy of Self-Help Multicomponent Lifestyle Medicine Intervention and Cognitive Behavioral Therapy for Depressive Symptoms: A Pilot Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (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 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.

Detailed description

This study will serve as a pioneering attempt to investigate the comparative efficacy of self-help multicomponent lifestyle medicine intervention and cognitive behavioral therapy for reducing depressive symptoms. The proposed study will pave the way for future intervention development and provide the evidence base for the integration of lifestyle-based interventions into the current treatment model. 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

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Lifestyle medicine	6 weeks booklet-delivered multicomponent lifestyle medicine intervention
BEHAVIORAL	Cognitive behavioral therapy	6 weeks booklet-delivered self-help cognitive behavioral therapy

Timeline

• Start date: 2023-01-15
• Primary completion: 2023-08-31
• Completion: 2023-12-31
• First posted: 2023-01-20
• Last updated: 2023-01-20

Locations

1 site across 1 country: Hong Kong