Clinical trial NCT04295369: Lifestyle Hub Pilot Study
Official title: Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Improving Psychological Well-being: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Distress
Keywords: Psychological Well-being
Lifestyle Medicine
Self-help
Depression
Anxiety
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Depression Anxiety Stress Scales-21
timeFrame: Immediately post-treatment and 1-month post treatment
Secondary outcomes:
measure: Change in The Insomnia Severity Index (ISI)
timeFrame: Baseline, immediately post-treatment and 1-month post treatment
measure: Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
timeFrame: Baseline, immediately post-treatment and 1-month post treatment
measure: Change in the Health-Promoting Lifestyle Profile (HPLP II)
timeFrame: Baseline, immediately post-treatment and 1-month post treatment
measure: Change in the Sheehan Disability Scale (SDS)
timeFrame: Baseline, immediately post-treatment and 1-month post treatment
measure: Change in the Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Baseline, immediately post-treatment and 1-month post treatment
measure: Change in the Food Frequency Questionnaires (FFQs)
timeFrame: Baseline, immediately post-treatment and 1-month post treatment
measure: Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
timeFrame: Baseline, immediately post-treatment and 1-month post treatment
measure: Self-developed survey
timeFrame: Baseline
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: