Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools

NCT04875663 | Unknown

• 1 other identifier: PSY015
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Lifestyle medicine; Depression

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (6)

• Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)

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

• Change in Insomnia Severity Index (ISI)

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

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

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

• Change in the Health-Promoting Lifestyle Profile (HPLP II)

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

• Change in the Sheehan Disability Scale (SDS)

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

Other Outcomes (1)

• Change in the Credibility-Expectancy Questionnaire (CEQ)

  Baseline and immediately after treatment

Study Arms (3)

Lifestyle medicine intervention with self-tracking tools

EXPERIMENTAL

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

Behavioral: Lifestyle Medicine

Pure lifestyle medicine intervention

EXPERIMENTAL

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

Behavioral: Lifestyle Medicine

Care-As-Usual

NO INTERVENTION

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

Interventions

Lifestyle Medicine BEHAVIORAL

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

Lifestyle medicine intervention with self-tracking tools; Pure lifestyle medicine intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Vincent Wing-Hei Wong

CONTACT

+852 39436575; vincentwongWH@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 6, 2021
• Study Start: July 1, 2021
• Primary Completion: May 31, 2022
• Study Completion: June 30, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

HK (1)