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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Depression

Treatments: Behavioral: Group-based Lifestyle Medicine Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05454761

PSY022

Details and patient eligibility

About

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.

Enrollment: 141 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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141 participants in 3 patient groups

Lifestyle medicine intervention with self-tracking tools

Experimental group

Description:

Lifestyle intervention including diet, sleep, exercise, relaxation, and mindfulness. Self-tracking tools including a smartphone application and an Actigraphy will be given.

Treatment:

Behavioral: Group-based Lifestyle Medicine Program

Pure lifestyle medicine intervention

Experimental group

Description:

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

Treatment:

Behavioral: Group-based Lifestyle Medicine Program

Care-As-Usual

No Intervention group

Description:

continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments