Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools

The Chinese University of Hong Kong

Status: Unknown

Conditions: Depression

Treatments: Behavioral: Lifestyle Medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT04875663

PSY015

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 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: Lifestyle Medicine

Pure lifestyle medicine intervention

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Medicine

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