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DepressionNCT04875663

Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools

A study testing Lifestyle Medicine in people with Depression, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study will be a randomized controlled trial on the effects of group-based LM as an intervention for depression. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression
What is being tested?
Lifestyle Medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteHong Kong
Study dates
1 Jul 2021to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hong Kong residents aged ≥ 18 years
  • Cantonese language fluency and readability
  • A Patient Health Questionnaire 9 items (PHQ-9) score of at least 10, indicating a moderate level of depression
  • Possession of an internet-enabled mobile device (iOS or Android operating system)
  • Willingness to provide informed consent and comply with the trial protocol

Who cannot join

  • 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)
  • 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)
  • Current involvement in lifestyle changes supervised by professionals
  • Unstable medication or current participation in any psychotherapy for depression
  • Pregnancy
  • Hospitalization
  • Current participation in any other trial(s)

Trial locations and contacts

1 site in 1 country.

Vincent Wing-Hei Wong contact

+852 39436575

vincentwongWH@link.cuhk.edu.hk

Hong Kong1 site

  • The Chinese University of Hong Kong

    Shatin

Other trials in Hong Kong

About this study

Official title: Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools: A Randomized Controlled Trial

This study will be a randomized controlled trial on the effects of group-based LM as an intervention for depression. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 90 eligible participants will be randomly assigned to either the LM intervention with self-tracking tools (LM/S), pure LM intervention (LM), or care-as-usual (CAU) control group in a ratio of 1:1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. In order to obtain unbiased data with respect to the participants' attitudes and behaviors, incomplete disclosure will be used to withhold the self-tracking component in this trial. Participants in the two LM groups will receive six weekly group lifestyle modification sessions (~2 hours each) at the Chinese University of Hong Kong (an online approach will be adopted if face-to-face sessions are not possible due to COVID-19). The group treatment will primarily be delivered by clinical psychology trainees under the supervision of a clinical psychologist and other healthcare professionals such as a dietitian and a fitness trainer. The CAU group will continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments. Both the treatment groups and control group will complete a set of online questionnaires before the treatment commences, immediately after treatment, and 12 weeks after the treatment sessions are completed. In addition, participants in the LM/S group will complete a set of self-developed survey questions related to lifestyle and mood on a daily basis.

Conditions
Depression
Being tested
Lifestyle Medicine
Keywords
Lifestyle medicine, Depression
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle MedicineBehavioural

    Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness

Study groups in NCT04875663
Study groupRoleWhat they receive
Lifestyle medicine intervention with self-tracking toolsExperimentalLifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness. Self-tracking tools including a smartphone application and an Actigraphy will be given.
Receives: Behavioral: Lifestyle Medicine
Pure lifestyle medicine interventionExperimentalLifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness.
Receives: Behavioral: Lifestyle Medicine
Care-As-UsualNo interventioncontinue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Patient Health Questionnaire (PHQ-9)

    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).

    Measured: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed

Secondary outcomes (6)

  1. 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).

    Measured: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed

  2. Change in 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.

    Measured: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed

  3. Change in the World Health Organization Quality of Life Instruments (WHOQOL-BREF)

    WHOQOL-BREF consists of 24 items assessing perception of quality of life (QoL) in four domains, including physical health, psychological, social relationships, and environment, and two items on overall QoL and general health. The domain scores were transformed into a linear scale between 0 and 100 following the scoring guidelines. A higher score indicated a better QoL.

    Measured: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed

  4. 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.

    Measured: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed

  5. 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

    Measured: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed

  6. 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.

    Measured: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start1 Jul 2021 (estimated)
  3. Primary completion31 May 2022 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875663
Sponsor's protocol ID
PSY015
Status last verified
May 2021
First submitted
5 May 2021
Last updated
6 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Medicine in people with Depression, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Vincent Wing-Hei Wong (+852 39436575, vincentwongWH@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Patient Health Questionnaire (PHQ-9) (time frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04875663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.

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