DepressionNCT05405803
To Improve Depressive Symptoms Using a Web-App
A study testing Web-App based Lifestyle Physical Activity Promotion Program in people with Depression, run by Vanderbilt University at 1 site in United States.
Trial summary
This study is being done to answer a question on whether a Web App-based Lifestyle Physical Activity Promotion Program is effective in improving depressive symptom experience of midlife Korean American women (WPAPP-K). Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- Web-App based Lifestyle Physical Activity Promotion Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2022to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- self-reported midlife Korean-American women
- aged 40 to 60 years
- whose parents and grandparents are of Korean descent;
- who can read and write English or Korean;
- who currently reside in the United States;
- who are sedentary (without any disabilities preventing physical activity);
- who are online through computers or mobile devices;
- have experienced depressive symptoms during the past two weeks (1 to 10 on the Patient Health Questionnaire [PHQ-9],which is equivalent to the cut-point of minimal to moderate depression.
Who cannot join
- major signs or symptoms suggestive of pulmonary or CVD
- history of a myocardial infarction, stroke, or Type I diabetes mellitus
- blood pressure higher than 160/100 mm Hg
- Use of beta-blockers, diltiazem, or verapamil
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37240
Wonshik Chee, PhD, 615-343-4671, wpapp.help@vanderbilt.edu
About this study
Official title: A Web-App Based Lifestyle Physical Activity Promotion Program to Improve Depressive Symptom Experience: Midlife Korean American Women
This study is being done to answer a question on whether a Web App-based Lifestyle Physical Activity Promotion Program is effective in improving depressive symptom experience of midlife Korean American women (WPAPP-K).
Read the detailed description
This study is being done to answer a question on whether a Web App-based Lifestyle Physical Activity Promotion Program is effective in improving depressive symptom experience of midlife Korean American women (WPAPP-K). Korean American midlife women tend to suffer from depressive symptoms due to their menopausal transition, cultural background, age, and gender. The WPAPP-K program that the investigators are testing is designed to help Korean American midlife women by providing information and coaching/support to increase lifestyle physical activity and subsequently improve their depressive symptom experience during the menopausal transition. The research team wants to know if the program improves depressive symptom experience of Korean American midlife women as designed.
- Conditions
- Depression
- Being tested
- Web-App based Lifestyle Physical Activity Promotion Program, The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines
- Keywords
- Depression, Korean american women
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-App based Lifestyle Physical Activity Promotion ProgramBehavioural
Also called WPAPP-K
WPAPP-K includes group and individual coaching/support by health care providers, peer coaching/support, and information to change the women's attitudes, self-efficacy, perceived barriers, and social influences.
The program includes 3 components in 2 languages (English and Korean):
- Social media sites: allow participants to share their experiences and to receive individual and group coaching/ support from culturally matched peers and healthcare providers.
- Interactive online educational sessions: information on 15 topics related to depressive symptoms and lifestyle physical activity.
- Online Resources: include 20 links in English or Korean (only from scientific authorities including NIH, CDC,etc.).
Weekly group coaching and support will start after the first 10 participants are enrolled, but individual coaching/support will start as soon as a participant enrolls.
The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelinesBehavioural
A link to the CDC website will be provided through the project website, and participants will be asked to use it during the study period (12 months). Their use of the CDC website will be automatically measured through the project website.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will be asked to visit WPAPP-K at least two times a week for 12 months. Receives: Behavioral: Web-App based Lifestyle Physical Activity Promotion Program; Behavioral: The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines |
| Control group | Active comparator | Participants will have access to a link of the CDC website from baseline and during the duration of the study (12 months). Receives: Behavioral: The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K)
The Center for Epidemiologic Studies Depression Scale-Korean (CESD-K) measures the frequency of depressive symptoms in the past week. It includes 20 items on the level of depression (range=0~60). 21 as a cutoff score, indicating presence of depressive symptoms, because Koreans give negative responses for positive effects. High scores indicating greater depressive symptoms. A lower score correlates with better outcome.
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention (T2)
Change in Acculturation Stress Scale (ASS)
12 questions to assess the magnitude of stress associated with acculturation process (e.g., language difficulties, economic and social conflicts). Each with 4-point Likert scale (0=not stressful to 3=very stressful). Total possible score 0-36 with higher score correlating with worse outcome.
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in Social Readjustment Rating Scale (SRRS)
57 items on life events (e.g., death, marriage, empty nest, etc.), giving different weighting depending on the severity of the stressor (possible total score 0 to 100). Higher score correlates with higher stress.
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in Personal Resource Questionnaire (PRQ-2000)
15 7-point Likert scale items measuring perceived level of social support. 5 dimensions: (a) provision for attachment/intimacy; (b) social integration; (c) opportunity for nurturing behavior; (d) reassurance of worth; and (e) the availability of informational, emotional, and material helps.
Total possible score range: 15 to 105. Higher scores indicating more support; higher scores are better outcomes.
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Secondary outcomes (7)
Change in Kaiser Physical Activity Survey (KPAS)
The KPAS is a self-report measure regarding physical activity and living habits. Survey consists of 38 items; 4 domains: household and family care activities, occupational activities, active living habits, participation in sports/ exercise. Activity indices were created for each domain of activity by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5. Total activity index is calculated as the sum of all four indices: Total activity = (household/caregiving index*0.25 + occupational index*0.25 + active living index*0.25 + sports/exercise index*0.25) * 4.
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in total number of steps using Fitbit
Lifestyle physical activity score using Fitbit, measuring number of steps.
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in time of exercise using Fitbit
Lifestyle physical activity score using Fitbit, measuring time of exercise.
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in exercise intensity during using Fitbit
Lifestyle physical activity score using Fitbit, measuring type of exercise intensity (low, medium, or high intensity). Higher intensity correlates with better outcome.
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in resting heart rate using Fitbit
Fitbit wil record continuous, automatic, wrist-based resting heart rates.
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in BMI from baseline
2 questions on body weight and height to measure BMI (BMI calculated in kg/m).
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in waist circumference
The participants will measure their waist circumferences to the nearest cm at the narrowest part of the torso above the umbilicus and below the xiphoid using the paper rulers that will be mailed to them.136 Information with pictures on how to correctly measure and assistance by phone and/or Webcam will be provided.
Measured: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start12 Dec 2022
- Primary completionJun 2027 (estimated)
- Study completionJan 2028 (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.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Eun-Ok Im, Vanderbilt University
- Investigators
- Eun-Ok Im, PhD, MPH, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405803
- Sponsor's protocol ID
- STUDY00004809
- Other IDs
- 1R01NR020334-01
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the research team decides to share the data with the researcher, the data in SPSS format, abstract, and original findings of the proposed study will be provided to the researcher. The data will have no identifying information to link a subject to her/his data.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-App Based Lifestyle Physical Activity Promotion Program to Improve Depressive Symptom Experience: Midlife Korean American Women
- ClinicalTrials.gov ID
- NCT05405803
- Acronym / sponsor ID
- STUDY00004809
- Conditions
- Depression
- Keywords
- Depression, Korean american women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 Jun 2022 (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.
This study is being done to answer a question on whether a Web App-based Lifestyle Physical Activity Promotion Program is effective in improving depressive symptom experience of midlife Korean American women (WPAPP-K).
Detailed description
This study is being done to answer a question on whether a Web App-based Lifestyle Physical Activity Promotion Program is effective in improving depressive symptom experience of midlife Korean American women (WPAPP-K). Korean American midlife women tend to suffer from depressive symptoms due to their menopausal transition, cultural background, age, and gender. The WPAPP-K program that the investigators are testing is designed to help Korean American midlife women by providing information and coaching/support to increase lifestyle physical activity and subsequently improve their depressive symptom experience during the menopausal transition. The research team wants to know if the program improves depressive symptom experience of Korean American midlife women as designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Web-App based Lifestyle Physical Activity Promotion Program, Behavioral: The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelinesParticipants will be asked to visit WPAPP-K at least two times a week for 12 months. |
| Control group | Active comparator | Behavioral: The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelinesParticipants will have access to a link of the CDC website from baseline and during the duration of the study (12 months). |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- self-reported midlife Korean-American women
- aged 40 to 60 years
- whose parents and grandparents are of Korean descent;
- who can read and write English or Korean;
- who currently reside in the United States;
Key exclusion criteria (4 listed)
- major signs or symptoms suggestive of pulmonary or CVD
- history of a myocardial infarction, stroke, or Type I diabetes mellitus
- blood pressure higher than 160/100 mm Hg
- Use of beta-blockers, diltiazem, or verapamil
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 |
|---|---|---|
| Web-App based Lifestyle Physical Activity Promotion ProgramAlso: WPAPP-KWPAPP-K includes group and individual coaching/support by health care providers, peer coaching/support, and information to change the women's attitudes, self-efficacy, perceived barriers, and social influences. The program includes 3 components in 2 languages (English and Korean): 1. Social media sites: allow participants to share their experiences and to receive individual and group coaching/ support from culturally matched peers and healthcare providers. 2. Interactive online educational sessions: information on 15 topics related to depressive symptoms and lifestyle physical activity. 3. Online Resources: include 20 links in English or Korean (only from scientific authorities including NIH, CDC,etc.). Weekly group coaching and support will start after the first 10 participants are enrolled, but individual coaching/support will start as soon as a participant enrolls. | Behavioural | Intervention Group |
| The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelinesA link to the CDC website will be provided through the project website, and participants will be asked to use it during the study period (12 months). Their use of the CDC website will be automatically measured through the project website. | Behavioural | Control group, Intervention Group |
Primary outcome
Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K)
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention (T2)
The Center for Epidemiologic Studies Depression Scale-Korean (CESD-K) measures the frequency of depressive symptoms in the past week. It includes 20 items on the level of depression (range=0~60). 21 as a cutoff score, indicating presence of depressive symptoms, because Koreans give negative responses for positive effects. High scores indicating greater depressive symptoms. A lower score correlates with better outcome.
Change in Acculturation Stress Scale (ASS)
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
12 questions to assess the magnitude of stress associated with acculturation process (e.g., language difficulties, economic and social conflicts). Each with 4-point Likert scale (0=not stressful to 3=very stressful). Total possible score 0-36 with higher score correlating with worse outcome.
Change in Social Readjustment Rating Scale (SRRS)
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
57 items on life events (e.g., death, marriage, empty nest, etc.), giving different weighting depending on the severity of the stressor (possible total score 0 to 100). Higher score correlates with higher stress.
Change in Personal Resource Questionnaire (PRQ-2000)
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
15 7-point Likert scale items measuring perceived level of social support. 5 dimensions: (a) provision for attachment/intimacy; (b) social integration; (c) opportunity for nurturing behavior; (d) reassurance of worth; and (e) the availability of informational, emotional, and material helps. Total possible score range: 15 to 105. Higher scores indicating more support; higher scores are better outcomes.
7 secondary outcomes
Change in Kaiser Physical Activity Survey (KPAS)
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in total number of steps using Fitbit
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in time of exercise using Fitbit
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in exercise intensity during using Fitbit
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in resting heart rate using Fitbit
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in BMI from baseline
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Change in waist circumference
Time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. When the research team decides to share the data with the researcher, the data in SPSS format, abstract, and original findings of the proposed study will be provided to the researcher. The data will have no identifying information to link a subject to her/his data.
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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.
Eun-Ok Im, PhD, MPH principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-App based Lifestyle Physical Activity Promotion Program in people with Depression, run by Vanderbilt University at 1 site in United States.
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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wonshik Chee, PhD (615-343-4671, wpapp.help@vanderbilt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K) (time frame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention (T2)). The study lists 4 primary outcomes in all. 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 30 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.