Depression Clinical Trial
Official title:
Comparative Efficacy of Self-Help Multicomponent Lifestyle Medicine Intervention and Cognitive Behavioral Therapy for Depressive Symptoms: A Pilot Randomized Controlled Trial
The objective of this proposed pilot randomized controlled trial is to examine the efficacy of self-help multicomponent lifestyle medicine intervention and cognitive behavioral therapy relative to a wait-list control group for alleviating depressive symptoms among Hong Kong Chinese adults.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | December 31, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Hong Kong residents - Aged 18 or above - Able to read Chinese and write in Chinese or English - Have a Patient Health Questionnaire-9 (PHQ-9) total score of 10 or higher indicating at least moderate level of depressive symptoms - Willing to provide informed consent and comply with the trial protocol - Have an Internet-enabled mobile device (iOS or Android operating system) (for data collection purposes) Exclusion Criteria: - Received psychotherapy for depression and/or insomnia in the past 6 months - A change in psychotropic drugs or over-the-counter medications that target depression and/or insomnia within 2 weeks before the baseline assessment - A PHQ-9 item-9 score equal to or higher than 2, indicating a moderate level of suicidal risk that requires active crisis management (referral information to professional mental health services will be provided) - Currently participating in another interventional study that may potentially improve mental health - Pregnancy - Self-disclosure of having unsafe conditions for which physical activity or a change in diet was contraindicated by physicians or other health professionals (e.g., dietitian) - Self-disclosure of a diagnosis of any major psychiatric, medical, or neurocognitive disorders that make participation unsuitable or interfere with the adherence to the interventions |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Sha Tin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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, immediate post-intervention, and 3-month post-intervention | |
Secondary | 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, immediate post-intervention, and 3-month post-intervention | |
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, immediate post-intervention, and 3-month post-intervention | |
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, immediate post-intervention, and 3-month post-intervention | |
Secondary | Change in The Short Multidimensional Inventory Lifestyle Evaluation (SMILE) | The SMILE is a 43-item self-report questionnaire designed to measure 7 aspects of lifestyle, which included diet and nutrition (7-item), substance use (4-item), exercise (3-item), stress management (10-item), sleep management (5- item), social support (10-item), and environmental exposures (4-item). Each item is rated on a 4-point Likert scale. The possible response categories of each item are always (4), several days (3), seldom (2), and never (1). For items 3-4, 8-11, 21, 29, and 40-41, they will be reverse scored. The total score of a lifestyle aspect equals the sum of the respected item score, while the overall lifestyle pattern score can be calculated by summing up the 43-item scores. The higher the score, the better the lifestyle pattern. | Baseline, immediate post-intervention, and 3-month post-intervention | |
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, immediate post-intervention, and 3-month post-intervention | |
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 a short form of the IPAQ-C. | Baseline, immediate post-intervention, and 3-month post-intervention | |
Secondary | Change in the Treatment Acceptability and Adherence Scale (TAAS) | TAAS is a self-reported, ten-item questionnaire that is rated by a seven-point Likert scale from 1 to 7, and it aims at evaluating the clients' attitude toward the treatment sessions by four domains, including acceptability, adherence, drop-out, and distress. Specific wording referencing "anxiety" was changed to refer to "depression". | Baseline and immediate post-intervention | |
Secondary | Change in the Credibility-Expectancy Questionnaire (CEQ) | The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. Specific wording referencing "anxiety" was changed to refer to "depression". | Baseline and immediate post-intervention | |
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 |
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