Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence

July 11, 2022 updated by: Fiona YY Ho, Chinese University of Hong Kong

Effects of Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence: A Randomized Controlled Trial and a Process Evaluation

The proposed study will be a randomized, assessor-blind controlled trial embedding both outcome and process evaluations of a 6-week group LM intervention with/without self-tracking tools (Study I). The outcome evaluation will examine the effects of LM-S and LM alone vs. CAU, and the process evaluation will enhance the understanding of the causal assumptions that underpin LM to inform policy and clinical practice. Eligible participants with at least a moderate level of depression will be randomly assigned to the LM- S, LM alone, and CAU groups in a 1:1:1 allocation ratio. The study period will be 18 weeks. Assessments at baseline, week 7 (1-week post-intervention), and week 18 (12-week post-intervention) will be managed by an independent assessor (a research assistant, RA) who is blind to the group allocation. The proposed trial and the nested pilot study will follow the CONSORT and STROBE guidelines, respectively. The intervention will be provided free of charge.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. at least 18 years of age
  2. Cantonese language fluency and readability
  3. a PHQ-9 score of at least 10, indicating a moderate level of depression
  4. current DSM-IV diagnostic criteria of major depressive episode based on the Mini International Neuropsychiatric Interview (MINI)
  5. possession of an internet-enabled mobile device (iOS or Android operating system)
  6. willingness to provide informed consent and comply with the trial protocol.

Exclusion Criteria:

  1. the presence of other current psychiatric disorders as assessed by the MINI
  2. any medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise or a change in diet are not recommended by physicians)
  3. current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score > 2 (referral information to professional mental health services will be provided)
  4. current involvement in lifestyle changes supervised by professionals
  5. intake of medication or current participation in any psychotherapy for depression
  6. pregnancy
  7. hospitalization
  8. current participation in any other trial(s).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lifestyle medicine intervention with self-tracking tools
Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness. Self-tracking tools including a smartphone application and an Actigraphy will be given.
Behavioral: Group-based Lifestyle Medicine Program
Participants will receive four core modules that focus on lifestyle modifications. Core Module 1 will be Diets and Nutrition. This module aims to provide simple and evidence-based information regarding nutrition for improving and maintaining mental health. Core Module 2 will be Physical Activity. Participants will practice various types of gentle and adaptable exercises during the session and learn simple ways to incorporate exercise into their daily lives. Core Module 3 will be Sleep Management. This module will include basic facts about sleep, with a focus on psychoeducation on insomnia and how the relationship between circadian and social rhythms relate to sleep and mental health. Core Module 4 will be Stress Management. This module will include psychoeducation about stress, worry management, the cultivation of positive psychology, and relaxation techniques such as diaphragmatic breathing and progressive muscle relaxation.
Experimental: Pure lifestyle medicine intervention
Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness.
Behavioral: Group-based Lifestyle Medicine Program
Participants will receive four core modules that focus on lifestyle modifications. Core Module 1 will be Diets and Nutrition. This module aims to provide simple and evidence-based information regarding nutrition for improving and maintaining mental health. Core Module 2 will be Physical Activity. Participants will practice various types of gentle and adaptable exercises during the session and learn simple ways to incorporate exercise into their daily lives. Core Module 3 will be Sleep Management. This module will include basic facts about sleep, with a focus on psychoeducation on insomnia and how the relationship between circadian and social rhythms relate to sleep and mental health. Core Module 4 will be Stress Management. This module will include psychoeducation about stress, worry management, the cultivation of positive psychology, and relaxation techniques such as diaphragmatic breathing and progressive muscle relaxation.
No Intervention: Care-As-Usual
continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in the Patient Health Questionnaire (PHQ-9)
Time Frame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
The PHQ-9, a 20-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).
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Insomnia Severity Index (ISI)
Time Frame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
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.
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Change in the Health-Promoting Lifestyle Profile (HPLP II)
Time Frame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
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.
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Change in the Sheehan Disability Scale (SDS)
Time Frame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Change in Quality-adjusted Life Years - The Short Form Six-Dimension (SF-6D)
Time Frame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
The Short Form Six-Dimension (SF-6D) is a self-report measure that assesses health-related quality of life to estimate participant's quality-adjusted life years (QALYs). This instrument was validated in the Chinese population and widely applied in previous mental health research.
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Change in Hospital Anxiety and Depression Scale (HADS)
Time Frame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
HADS is a 14-item self-rated questionnaire which consists of two 7-item subscales that measure the presence of anxiety and depression symptoms respectively. Each item is rated on a 4-point-scale (0-3) by the participant. The greater the score, the more psychologically distressed the respondent is.
[Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the Credibility-Expectancy Questionnaire (CEQ)
Time Frame: [Time Frame: Baseline and immediately after treatment]
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.
[Time Frame: Baseline and immediately after treatment]
Treatment Acceptability Scale (TAS)
Time Frame: [Time Frame: Baseline and immediately after treatment]
An 8-item scale of the willingness to utilize or recommend the intervention.
[Time Frame: Baseline and immediately after treatment]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSY022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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