Incorporating Ecological Momentary Assessment and Personalized Telephone Support Into Group-Based Exercise Intervention for Depressive Symptoms
NCT ID: NCT05704504
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-01-24
2023-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 ecological momentary assessment (EMA)and personalized telephone support.
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.
Group-based exercise intervention (EXE)
Participants in the EXE group will receive a 6-week group-based exercise intervention.
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.
No intervention control group (CON)
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.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Aged ≥ 18 years
3. Able to read Chinese and type in Chinese or English
4. Have a Patient Health Questionnaire-9(PHQ-9) item score ≥10 indicating at least moderate level of depressive symptoms
5. Have an International Physical Activities Questionnaire- Chinese version (IPAQ-C) score \<600 MET indicating physically inactive.
6. Have an Internet-enabled mobile device (iOS or Android operating system)
7. Willing to provide informed consent and comply with the trial protocol
Exclusion Criteria
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 interventional study that may potentially improve mental health
5. Pregnancy
6. 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)
18 Years
65 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Fiona YY Ho
Assistant Professor
Locations
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The Chinese University of Hong Kong
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PSY028
Identifier Type: -
Identifier Source: org_study_id
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