Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools
Primary Purpose
Depression
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 focused on measuring Lifestyle medicine, Depression
Eligibility Criteria
Inclusion Criteria:
- Hong Kong residents aged ≥ 18 years
- Cantonese language fluency and readability
- A Patient Health Questionnaire 9 items (PHQ-9) score of at least 10, indicating a moderate level of depression
- Possession of an internet-enabled mobile device (iOS or Android operating system)
- Willingness to provide informed consent and comply with the trial protocol
Exclusion Criteria:
- Current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score > 2 (referral information to professional mental health services will be provided)
- Any 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 or a change in diet are not recommended by physicians)
- Current involvement in lifestyle changes supervised by professionals
- Unstable medication or current participation in any psychotherapy for depression
- Pregnancy
- Hospitalization
- Current participation in any other trial(s)
Sites / Locations
- The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Lifestyle medicine intervention with self-tracking tools
Pure lifestyle medicine intervention
Care-As-Usual
Arm Description
Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness. Self-tracking tools including a smartphone application and an Actigraphy will be given.
Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness.
continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments
Outcomes
Primary Outcome Measures
Change in the Patient Health Questionnaire (PHQ-9)
The PHQ-9, a 20-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).
Secondary Outcome Measures
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).
Change in 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 World Health Organization Quality of Life Instruments (WHOQOL-BREF)
WHOQOL-BREF consists of 24 items assessing perception of quality of life (QoL) in four domains, including physical health, psychological, social relationships, and environment, and two items on overall QoL and general health. The domain scores were transformed into a linear scale between 0 and 100 following the scoring guidelines. A higher score indicated a better QoL.
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 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.
Full Information
NCT ID
NCT04875663
First Posted
May 5, 2021
Last Updated
May 5, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04875663
Brief Title
Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools
Official Title
Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (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 be a randomized controlled trial on the effects of group-based LM as an intervention for depression. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 90 eligible participants will be randomly assigned to either the LM intervention with self-tracking tools (LM/S), pure LM intervention (LM), or care-as-usual (CAU) control group in a ratio of 1:1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. In order to obtain unbiased data with respect to the participants' attitudes and behaviors, incomplete disclosure will be used to withhold the self-tracking component in this trial. Participants in the two LM groups will receive six weekly group lifestyle modification sessions (~2 hours each) at the Chinese University of Hong Kong (an online approach will be adopted if face-to-face sessions are not possible due to COVID-19). The group treatment will primarily be delivered by clinical psychology trainees under the supervision of a clinical psychologist and other healthcare professionals such as a dietitian and a fitness trainer. The CAU group will continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments. Both the treatment groups and control group will complete a set of online questionnaires before the treatment commences, immediately after treatment, and 12 weeks after the treatment sessions are completed. In addition, participants in the LM/S group will complete a set of self-developed survey questions related to lifestyle and mood on a daily basis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Lifestyle medicine, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle medicine intervention with self-tracking tools
Arm Type
Experimental
Arm Description
Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness. Self-tracking tools including a smartphone application and an Actigraphy will be given.
Arm Title
Pure lifestyle medicine intervention
Arm Type
Experimental
Arm Description
Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness.
Arm Title
Care-As-Usual
Arm Type
No Intervention
Arm Description
continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Medicine
Intervention Description
Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness
Primary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9, a 20-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 after treatment, and 12 weeks after the treatment sessions are completed
Secondary Outcome Measure Information:
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 after treatment, and 12 weeks after the treatment sessions are completed
Title
Change in 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 after treatment, and 12 weeks after the treatment sessions are completed
Title
Change in the World Health Organization Quality of Life Instruments (WHOQOL-BREF)
Description
WHOQOL-BREF consists of 24 items assessing perception of quality of life (QoL) in four domains, including physical health, psychological, social relationships, and environment, and two items on overall QoL and general health. The domain scores were transformed into a linear scale between 0 and 100 following the scoring guidelines. A higher score indicated a better QoL.
Time Frame
Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
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 after treatment, and 12 weeks after the treatment sessions are completed
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 after treatment, and 12 weeks after the treatment sessions are completed
Title
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Description
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.
Time Frame
Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Other Pre-specified Outcome Measures:
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 and immediately after treatment
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
Cantonese language fluency and readability
A Patient Health Questionnaire 9 items (PHQ-9) score of at least 10, indicating a moderate level of depression
Possession of an internet-enabled mobile device (iOS or Android operating system)
Willingness to provide informed consent and comply with the trial protocol
Exclusion Criteria:
Current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score > 2 (referral information to professional mental health services will be provided)
Any 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 or a change in diet are not recommended by physicians)
Current involvement in lifestyle changes supervised by professionals
Unstable medication or current participation in any psychotherapy for depression
Pregnancy
Hospitalization
Current participation in any other trial(s)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Wing-Hei Wong
Phone
+852 39436575
Email
vincentwongWH@link.cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Sha Tin
Country
Hong Kong
12. IPD Sharing Statement
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Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools
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