Clinical trial NCT04152850: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Depression, Anxiety
Keywords: Depression
Anxiety
Lifestyle Medicine
Self-help
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, immediately post-treatment and 1-month post treatment
measure: Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: Baseline, 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) (Lai et al., 2018; Macfarlane, Lee, Ho, Chan, & Chan, 2007)
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:
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.