NCT05704504

Incorporating Ecological Momentary Assessment and Personalized Telephone Support Into Group-Based Exercise Intervention for Depressive Symptoms

Incorporating Ecological Momentary Assessment and Personalized Telephone Support Into Group-Based Exercise Intervention for Depressive Symptoms: A Pilot Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (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 and acceptability of using smartphone-delivered ecological momentary assessment (EMA) and personalized telephone support to promote adherence to a 6-week group-based exercise intervention for improving depressive symptoms. Prior to all study procedures, eligible participants are required to complete an online informed consent via an in-house smartphone application, Longitudinax Pro. Around 60 eligible participants aged 18-65 years old with Patient Health Questionnaire (PHQ-9) total score ≥10 (Kroenke et al., 2001) and International Physical Activity Questionnaire (IPAQ) total score \<600 MET/week (Lai et al., 2018; Macfarlane et al., 2007) will be randomly assigned to either 1) group-based exercise intervention with EMA and personalized telephone support (SUP), 2) group-based exercise intervention (EXE), or no intervention control group (CON) in a ratio of 1:1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. The SUP and EXE groups will participate in a 6-week group-based exercise intervention. The intervention includes three biweekly group-based exercise sessions lasting for 120 minutes each (i.e., Week 1, 3, and 5). In addition, participants in the SUP will receive daily smartphone-delivered EMAs throughout the intervention period (i.e., 6-week) and 15-minute personalized telephone support delivered by a research personnel in Week 2, 4, and 6, respectively. Participants in the CON group will not be given any intervention during the study period but will be advised to remain their typical lifestyle throughout the trial period. The primary outcome of interest include depressive symptoms as measured by PHQ-9. The secondary outcomes will include anxiety symptoms, perceived insomnia severity, quality of life, functional impairment, and intervention evaluation at immediate post-intervention (Week 7) and 3-month follow-up assessments (Week 19).

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Group-based exercise intervention with EMA and personalized telephone support (SUP)	Participants in the SUP group will receive a 6-week group-based exercise intervention with EMA and personalized telephone support. The intervention content includes three 120-minute group-based exercise training sessions delivered by a physical trainer and three 15-minute personalized telephone sessions delivered by research personnel. The first group exercise session will include (1) assessments of current physical fitness, (2) psychoeducation of depression, (3) education on the benefits of exercise on mental health, (4) demonstration and group low-intensity exercise training, and (5) smart goal setting. A booklet that summarizes the session content will be provided to participants. The second and third group exercise sessions will include (1) reviewing exercise goals and EMA data, (2) problem-solving barriers to exercise, (3) group discussion on exercise experience, (4) demonstration and group moderate-intensity exercise training, and (5) smart goal setting.
BEHAVIORAL	Group-based exercise intervention (EXE)	Participants in the EXE group will receive a 6-week group-based exercise intervention. The intervention content includes three 120-minute group-based exercise training sessions delivered by a physical trainer at the Chinese University of Hong Kong. The first group exercise session will include (1) assessments of current physical fitness, (2) psychoeducation of depression, (3) education on the benefits of exercise on mental health, (4) demonstration and group low-intensity exercise training, and (5) smart goal setting. A booklet that summarizes the session content will be provided to participants. The second and the third group exercise sessions will include (1) reviewing exercise goals, (2) problem-solving barriers to exercise, (3) group discussion on exercise experience, (4) demonstration and group moderate-intensity exercise training, and (5) smart goal setting.

Timeline

• Start date: 2023-01-24
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2023-01-30
• Last updated: 2023-02-08

Locations

1 site across 1 country: Hong Kong