Back to resultsSelf-help Lifestyle Medicine for Depression and Anxiety
Primary Purpose
Depression, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Lifestyle Medicine
Sponsored by
About this trial
This is an interventional treatment trial for Depression, Anxiety focused on measuring Depression, Anxiety, Lifestyle Medicine, Self-help
Eligibility Criteria
Inclusion Criteria:
- Hong Kong residents
- Aged ≥ 18 years
- Have a Patient Health Questionnaire (PHQ-9) score ≥ 10 or Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
- Able to read Chinese and type in Chinese or English
- Have an Internet-enabled mobile device (iOS or Android operating system)
- Are willing to provide informed consent and comply with the trial protocol
Exclusion Criteria:
- Current involvement in psychotherapy or unstable medication for depression and/or anxiety
- Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk)
- Are having unsafe conditions and are not recommended for physical activity or a change in diet by physicians
- Having major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification
Sites / Locations
- The Chinese University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle Medicine Group
Waitlist Control Group
Arm Description
Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment
Outcomes
Primary Outcome Measures
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).
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
Secondary Outcome Measures
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.
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
SF-6D is 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.
Change in the Health-Promoting Lifestyle Profile (HPLP II)
The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
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.
Change in the Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Change in the Food Frequency Questionnaires (FFQs)
FFQs is a 18-item scale, including drinks, plant, animal products and cigarette intake, which measures the frequency of food intake over the past three months on a 7-point scale.
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C) (Lai et al., 2018; Macfarlane, Lee, Ho, Chan, & Chan, 2007)
Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from the short form of the International Physical Activity Questionnaire - Chinese version. The sample questions include: "On a typical weekday in the last 7 days, how many hours per day did you typically spend sitting?"; "On a typical weekend in the last 7 days, how many hours per day did you typically spend sitting?". Participants' engagement in brief strength and stamina-enhancing activity were assessed by asking the number of days they engaged in physical activity while seated and standing in the last seven days.
Self-developed survey
The self-developed survey will collect information including demographic information (e.g., age, gender, level of education, working industry, relationship status, and location of residence), substance use, body mass index (BMI), rest-activity pattern, and social rhythms, etc.
Full Information
NCT ID
NCT04152850
First Posted
November 4, 2019
Last Updated
March 9, 2020
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04152850
Brief Title
Self-help Lifestyle Medicine for Depression and Anxiety
Official Title
Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Reducing Depressive and Anxiety Symptoms: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study will examine the effects of smartphone-based lifestyle medicine (LM) for alleviating depressive and anxiety symptoms in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of depression and anxiety, modifying different lifestyle factors simultaneously, for example, diet, exercise, stress and sleep which are empirically supported by previous reviews, may be effective to reduce depressive and anxiety symptoms. Traditional Chinese medicine concepts will be integrated into the app to increase the acceptability towards mental health treatment. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for depression and anxiety.
Detailed Description
This study will be a randomized controlled trial on the effects of a culturally adapted self-help smartphone-based lifestyle medicine for reducing depressive and anxiety symptoms in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). With an estimation of 30% withdrawal, around 124 eligible participants will be randomly assigned to either smartphone-based lifestyle medicine (LM group) or the waitlist control group (WL group) in a ratio of 1:1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Depression, Anxiety, Lifestyle Medicine, Self-help
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Medicine Group
Arm Type
Experimental
Arm Title
Waitlist Control Group
Arm Type
No Intervention
Arm Description
Participants in the waitlist control group will receive the intervention after the immediate post-treatment assessment
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Medicine
Intervention Description
Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep and Traditional Chinese Medicine
Primary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
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).
Time Frame
Baseline, immediately post-treatment and 1-month post treatment
Title
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Description
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
Time Frame
Baseline, immediately post-treatment and 1-month post treatment
Secondary Outcome Measure Information:
Title
Change in the Insomnia Severity Index (ISI)
Description
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.
Time Frame
Baseline, immediately post-treatment and 1-month post treatment
Title
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Description
SF-6D is 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.
Time Frame
Baseline, immediately post-treatment and 1-month post treatment
Title
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Description
The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
Time Frame
Baseline, immediately post-treatment and 1-month post treatment
Title
Change in the Sheehan Disability Scale (SDS)
Description
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
Time Frame
Baseline, immediately post-treatment and 1-month post treatment
Title
Change in the Credibility-Expectancy Questionnaire (CEQ)
Description
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
Time Frame
Baseline, immediately post-treatment and 1-month post treatment
Title
Change in the Food Frequency Questionnaires (FFQs)
Description
FFQs is a 18-item scale, including drinks, plant, animal products and cigarette intake, which measures the frequency of food intake over the past three months on a 7-point scale.
Time Frame
Baseline, immediately post-treatment and 1-month post treatment
Title
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C) (Lai et al., 2018; Macfarlane, Lee, Ho, Chan, & Chan, 2007)
Description
Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from the short form of the International Physical Activity Questionnaire - Chinese version. The sample questions include: "On a typical weekday in the last 7 days, how many hours per day did you typically spend sitting?"; "On a typical weekend in the last 7 days, how many hours per day did you typically spend sitting?". Participants' engagement in brief strength and stamina-enhancing activity were assessed by asking the number of days they engaged in physical activity while seated and standing in the last seven days.
Time Frame
Baseline, immediately post-treatment and 1-month post treatment
Title
Self-developed survey
Description
The self-developed survey will collect information including demographic information (e.g., age, gender, level of education, working industry, relationship status, and location of residence), substance use, body mass index (BMI), rest-activity pattern, and social rhythms, etc.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hong Kong residents
Aged ≥ 18 years
Have a Patient Health Questionnaire (PHQ-9) score ≥ 10 or Generalized Anxiety Disorder 7-Item Scale (GAD-7) ≥ 8
Able to read Chinese and type in Chinese or English
Have an Internet-enabled mobile device (iOS or Android operating system)
Are willing to provide informed consent and comply with the trial protocol
Exclusion Criteria:
Current involvement in psychotherapy or unstable medication for depression and/or anxiety
Beck Depression Inventory (BDI-II) Item 9 score of at least 2 indicating a current moderate suicidal risk that requires active crisis management (referral information to professional services will be provided to those with serious suicidal risk)
Are having unsafe conditions and are not recommended for physical activity or a change in diet by physicians
Having major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Wong
Phone
+852 3943 6575
Email
wingheiwong7@gmail.com
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Ho
Phone
+852 39436575
Email
pmhlab@cuhk.edu.hk
12. IPD Sharing Statement
Citations:
PubMed Identifier
35025538
Citation
Wong VW, Ho FY, Shi NK, Tong JT, Chung KF, Yeung WF, Ng CH, Oliver G, Sarris J. Smartphone-delivered multicomponent lifestyle medicine intervention for depressive symptoms: A randomized controlled trial. J Consult Clin Psychol. 2021 Dec;89(12):970-984. doi: 10.1037/ccp0000695.
Results Reference
derived
Learn more about this trial
Self-help Lifestyle Medicine for Depression and Anxiety
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