Lifestyle Hub Pilot Study

Psychological Distress Clinical Trial

Official title:

Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Improving Psychological Well-being: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295369
• Other study ID #: PSY010
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: June 2020

Study information

• Verified date: March 2020
• Source: Chinese University of Hong Kong
• Contact: Vincent Wong
• Phone: +852 3943 6575
• Email: wingheiwong7[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will examine the effects of a smartphone-based lifestyle medicine (LM) for improving psychological well-being in Chinese population. Since a range of lifestyle factors are involved in the pathogenesis and progression of common mental disorders (e.g., depression and anxiety), modifying different lifestyle factors simultaneously may be effective to improve our psychological well-being. Chinese dietary recommendations will be integrated into the app to increase the acceptability towards mental health intervention. Through this study, we aim to promote evidence-based patient care and to improve help-seeking and access to evidence-based interventions for improving psychological well-being.

Description:

This study will be a randomized controlled trial on the effects of a culturally adapted self-help smartphone-based lifestyle medicine for improving psychological well-being in Chinese population. Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 30 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hong Kong residents

• Aged = 18 years

• 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:

• Have a Patient Health Questionnaire (PHQ-9) score = 10

• Have a Generalized Anxiety Disorder 7-Item Scale (GAD-7) = 8

• 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

Related Conditions & MeSH terms

• Psychological Distress

Intervention

Behavioral:
• Lifestyle Medicine
Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep, stress management, and Chinese dietary recommendations.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Depression Anxiety Stress Scales-21	DASS-21 is a 21-items scale, comprises of three sub-scales which measures the negative emotional states of depression, anxiety, and stress, over the past week. The DASS is based on a dimensional rather than a categorical conception of psychological disorder, thus it has no direct implications for the allocation of patients to discrete diagnostic categories. However, recommended cutoff scores for conventional severity labels (normal, moderate, severe) are given in the DASS Manual.	Immediately post-treatment and 1-month post treatment
Secondary	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.	Baseline, immediately post-treatment and 1-month post treatment
Secondary	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.	Baseline, immediately post-treatment and 1-month post treatment
Secondary	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.	Baseline, immediately post-treatment and 1-month post treatment
Secondary	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. The participant rates the extent to which work/school, social life and home life or family responsibilities are impaired by his or her symptoms on a 10 point visual analog scale. The numerical ratings of 0-10 can be translated into a percentage, if desired. The 3 items can also be summed into a single dimensional measure of global functional impairment that rages from 0 (unimpaired) to 30 (highly impaired).	Baseline, immediately post-treatment and 1-month post treatment
Secondary	Change in the Credibility-Expectancy Questionnaire (CEQ)	The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.	Baseline, immediately post-treatment and 1-month post treatment
Secondary	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.	Baseline, immediately post-treatment and 1-month post treatment
Secondary	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.	Baseline, immediately post-treatment and 1-month post treatment
Secondary	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.	Baseline