DepressionNCT05704504
Incorporating Ecological Momentary Assessment and Personalized Telephone Support Into Group-Based Exercise Intervention for Depressive Symptoms
A study testing Group-based exercise intervention with EMA and personalized telephone support (SUP) and Group-based exercise intervention (EXE) in people with Depression, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Group-based exercise intervention with EMA and personalized telephone support (SUP) and Group-based exercise intervention (EXE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 24 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Vincent Wong, pmhlab@cuhk.edu.hk
About this study
Official title: Incorporating Ecological Momentary Assessment and Personalized Telephone Support Into Group-Based Exercise Intervention for Depressive Symptoms: A Pilot Randomized Controlled Trial
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
- Being tested
- Group-based exercise intervention with EMA and personalized telephone support (SUP), Group-based exercise intervention (EXE)
- Keywords
- Depression, Exercise, Ecological momentary assessment, Randomised controlled trial
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based exercise intervention with EMA and personalized telephone support (SUP)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Secondary outcomes (8)
Change in the Generalized Anxiety Disorder 7-item Scale (GAD-7)
A brief 7-item instrument for screening for GAD and assessing its severity in clinical practice and research. Anxiety severity is categorized using scores of 5-9 (mild), 10-14 (moderate) and 15 or more (severe).
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Change in the Insomnia Severity Index (ISI)
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Change in the Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version
A preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality. The SF-6D index, scored from 0.0 (worst health state) to 1.0 (best health state).
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Change in the Short Multidimensional Inventory Lifestyle Evaluation (SMILE)
The SMILE is a 43-item self-report questionnaire designed to measure 7 aspects of lifestyle, which included diet and nutrition (7-item), substance use (4-item), exercise (3-item), stress management (10-item), sleep management (5- item), social support (10-item), and environmental exposures (4-item). Each item is rated on a 4-point Likert scale. The possible response categories of each item are always (4), several days (3), seldom (2), and never (1).
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Change in the Sheehan Disability Scale (SDS)
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from a short form of the International Physical Activity Questionnaire - Chinese version a short form of the IPAQ-C.
Measured: Baseline, immediate post-intervention, and 3-month follow-up
Change in the Treatment Acceptability and Adherence Scale (TAAS)
TAAS is a self-reported, ten-item questionnaire that is rated by a seven-point Likert scale from 1 to 7, and it aims at evaluating the clients' attitude toward the treatment sessions by four domains, including acceptability, adherence, drop-out, and distress.
Measured: Baseline and immediate post-intervention
Change in Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. Specific wording referencing "anxiety" was changed to refer to "depression".
Measured: Baseline and immediate post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start24 Jan 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona YY Ho, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704504
- Sponsor's protocol ID
- PSY028
- Status last verified
- Feb 2023
- First submitted
- 20 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Ecological Momentary Assessment and Personalized Telephone Support Into Group-Based Exercise Intervention for Depressive Symptoms: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05704504
- Acronym / sponsor ID
- PSY028
- Conditions
- Depression
- Keywords
- Depression, Exercise, Ecological momentary assessment, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-based exercise intervention with EMA and personalized telephone support (SUP) | Experimental | 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 ecological momentary assessment (EMA)and personalized telephone support. |
| Group-based exercise intervention (EXE) | Active comparator | Behavioral: Group-based exercise intervention (EXE)Participants in the EXE group will receive a 6-week group-based exercise intervention. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group-based exercise intervention with EMA and personalized telephone support (SUP) |
| 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. | Behavioural | Group-based exercise intervention (EXE) |
Primary outcome
Change in the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
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).
8 secondary outcomes
Change in the Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Change in the Insomnia Severity Index (ISI)
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Change in the Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Change in the Short Multidimensional Inventory Lifestyle Evaluation (SMILE)
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Change in the Sheehan Disability Scale (SDS)
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Time frame: Baseline, immediate post-intervention, and 3-month follow-up
Change in the Treatment Acceptability and Adherence Scale (TAAS)
Time frame: Baseline and immediate post-intervention
Change in Credibility-Expectancy Questionnaire (CEQ)
Time frame: Baseline and immediate post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based exercise intervention with EMA and personalized telephone support (SUP) and Group-based exercise intervention (EXE) in people with Depression, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Wu (3943 6575, pmhlab@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Patient Health Questionnaire (PHQ-9) (time frame: Baseline, immediate post-intervention, and 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.