Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools

NCT ID: NCT04875663

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-06-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Lifestyle Medicine

Intervention Type: BEHAVIORAL

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

Pure lifestyle medicine intervention

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

Group Type: EXPERIMENTAL

Lifestyle Medicine

Intervention Type: BEHAVIORAL

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle Medicine

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Hong Kong residents aged ≥ 18 years

2. Cantonese language fluency and readability

3. A Patient Health Questionnaire 9 items (PHQ-9) score of at least 10, indicating a moderate level of depression

4. Possession of an internet-enabled mobile device (iOS or Android operating system)

5. Willingness to provide informed consent and comply with the trial protocol

Exclusion Criteria

1. 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)

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 involvement in lifestyle changes supervised by professionals

4. Unstable medication or current participation in any psychotherapy for depression

5. Pregnancy

6. Hospitalization

7. Current participation in any other trial(s)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Fiona YY Ho

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Countries

Hong Kong

Central Contacts

Vincent Wing-Hei Wong

Role: CONTACT

vincentwongWH@link.cuhk.edu.hk

+852 39436575

Other Identifiers

PSY015

Identifier Type: -

Identifier Source: org_study_id