search
Back to results

To Improve Depressive Symptoms Using a Web-App

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-App based Lifestyle Physical Activity Promotion Program
The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Korean american women

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Emory University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control group

Arm Description

Participants will be asked to visit WPAPP-K at least two times a week for 12 months.

Participants will have access to a link of the CDC website from baseline and during the duration of the study (12 months).

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
Change in total number of steps using Fitbit
Lifestyle physical activity score using Fitbit, measuring number of steps.
Change in time of exercise using Fitbit
Lifestyle physical activity score using Fitbit, measuring time of exercise.
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.
Change in resting heart rate using Fitbit
Fitbit wil record continuous, automatic, wrist-based resting heart rates.
Change in BMI from baseline
2 questions on body weight and height to measure BMI (BMI calculated in kg/m).
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.

Full Information

First Posted
June 1, 2022
Last Updated
January 17, 2023
Sponsor
Emory University
Collaborators
National Institute of Nursing Research (NINR)
search

1. Study Identification

Unique Protocol Identification Number
NCT05405803
Brief Title
To Improve Depressive Symptoms Using a Web-App
Official Title
A Web-App Based Lifestyle Physical Activity Promotion Program to Improve Depressive Symptom Experience: Midlife Korean American Women
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Korean american women

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Participants will be asked to visit WPAPP-K at least two times a week for 12 months.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants will have access to a link of the CDC website from baseline and during the duration of the study (12 months).
Intervention Type
Behavioral
Intervention Name(s)
Web-App based Lifestyle Physical Activity Promotion Program
Other Intervention Name(s)
WPAPP-K
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K)
Description
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.
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention (T2)
Title
Change in Acculturation Stress Scale (ASS)
Description
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.
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Title
Change in Social Readjustment Rating Scale (SRRS)
Description
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.
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Title
Change in Personal Resource Questionnaire (PRQ-2000)
Description
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.
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Secondary Outcome Measure Information:
Title
Change in Kaiser Physical Activity Survey (KPAS)
Description
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.
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Title
Change in total number of steps using Fitbit
Description
Lifestyle physical activity score using Fitbit, measuring number of steps.
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Title
Change in time of exercise using Fitbit
Description
Lifestyle physical activity score using Fitbit, measuring time of exercise.
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Title
Change in exercise intensity during using Fitbit
Description
Lifestyle physical activity score using Fitbit, measuring type of exercise intensity (low, medium, or high intensity). Higher intensity correlates with better outcome.
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Title
Change in resting heart rate using Fitbit
Description
Fitbit wil record continuous, automatic, wrist-based resting heart rates.
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Title
Change in BMI from baseline
Description
2 questions on body weight and height to measure BMI (BMI calculated in kg/m).
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Title
Change in waist circumference
Description
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.
Time Frame
Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun-Ok Im, PhD, MPH
Phone
404-712-9805
Email
eun.ok.im@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun-Ok Im, PhD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun-Ok Im, PhD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
After publishing the major paper from the complete data to 10 years from the completion of the study
IPD Sharing Access Criteria
The researcher must request permission to conduct secondary analyses of the data from the PIs of the proposed study by e-mail or regular mail and provide the PIs with a 1-page long abstract (single-spaced) of the proposed analysis and her/his CV. 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 researcher will be requested to: (a) agree that she/he will provide the findings from her/his analyses to the PIs at the completion of the analyses, (b) acknowledge the original study and the NIH in her/his future publications, and (c) not use the findings from the data for any commercial purposes. This agreement will be made in written form. The data will be provided to the researcher as a password-protected zipped file that needs to be downloaded through the Emory Box cloud service.

Learn more about this trial

To Improve Depressive Symptoms Using a Web-App

We'll reach out to this number within 24 hrs