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

NCT05704504 | Unknown

• 1 other identifier: PSY028
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Depression; Exercise; Ecological momentary assessment; Randomised 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-intervention, and 3-month follow-up

Secondary Outcomes (8)

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

  Baseline, immediate post-intervention, and 3-month follow-up

• Change in the Insomnia Severity Index (ISI)

  Baseline, immediate post-intervention, and 3-month follow-up

• Change in the Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version

  Baseline, immediate post-intervention, and 3-month follow-up

• Change in the Short Multidimensional Inventory Lifestyle Evaluation (SMILE)

  Baseline, immediate post-intervention, and 3-month follow-up

• Change in the Sheehan Disability Scale (SDS)

  Baseline, immediate post-intervention, and 3-month follow-up

Study Arms (3)

Group-based exercise intervention with EMA and personalized telephone support (SUP)

EXPERIMENTAL

Participants in the SUP group will receive a 6-week group-based exercise intervention with ecological momentary assessment (EMA)and personalized telephone support.

Behavioral: Group-based exercise intervention with EMA and personalized telephone support (SUP)

Group-based exercise intervention (EXE)

ACTIVE COMPARATOR

Participants in the EXE group will receive a 6-week group-based exercise intervention.

Behavioral: Group-based exercise intervention (EXE)

No intervention control group (CON)

NO INTERVENTION

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.

Interventions

Group-based exercise intervention with EMA and personalized telephone support (SUP) BEHAVIORAL

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.

Group-based exercise intervention with EMA and personalized telephone support (SUP)

Group-based exercise intervention (EXE) BEHAVIORAL

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.

Group-based exercise intervention (EXE)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hong Kong residents
• Aged ≥ 18 years
• Able to read Chinese and type in Chinese or English
• Have a Patient Health Questionnaire-9(PHQ-9) item score ≥10 indicating at least moderate level of depressive symptoms
• Have an International Physical Activities Questionnaire- Chinese version (IPAQ-C) score \<600 MET indicating physically inactive.
• Have an Internet-enabled mobile device (iOS or Android operating system)
• 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 interventional study that may potentially improve mental health
• Pregnancy
• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Depression; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Gabriel Wu

CONTACT

3943 6575; pmhlab@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: January 30, 2023
• Study Start: January 24, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

HK (1)