Self-help Lifestyle Medicine for Depression and Anxiety

Depression, Anxiety Clinical Trial

Official title:

Effect of a Culturally Adapted Self-help Smartphone-based Lifestyle Intervention in Reducing Depressive and Anxiety Symptoms: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04152850
• Other study ID #: PSY009
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: September 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: September 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder

Intervention

Behavioral:
• Lifestyle Medicine
Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep and Traditional Chinese Medicine

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 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).	Baseline, immediately post-treatment and 1-month post treatment
Primary	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).	Baseline, 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.	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) (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.	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