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

NCT05454761 | Unknown

• 1 other identifier: PSY022
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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).

  [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]

Secondary Outcomes (5)

• Change in Insomnia Severity Index (ISI)

  [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]

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

  [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]

• Change in the Sheehan Disability Scale (SDS)

  [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]

• Change in Quality-adjusted Life Years - The Short Form Six-Dimension (SF-6D)

  [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]

• Change in Hospital Anxiety and Depression Scale (HADS)

  [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]

Other Outcomes (2)

• Change in the Credibility-Expectancy Questionnaire (CEQ)

  [Time Frame: Baseline and immediately after treatment]

• Treatment Acceptability Scale (TAS)

  [Time Frame: 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: Group-based Lifestyle Medicine Program

Pure lifestyle medicine intervention

EXPERIMENTAL

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

Behavioral: Group-based Lifestyle Medicine Program

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

Group-based Lifestyle Medicine Program BEHAVIORAL

Participants will receive four core modules that focus on lifestyle modifications. Core Module 1 will be Diets and Nutrition. This module aims to provide simple and evidence-based information regarding nutrition for improving and maintaining mental health. Core Module 2 will be Physical Activity. Participants will practice various types of gentle and adaptable exercises during the session and learn simple ways to incorporate exercise into their daily lives. Core Module 3 will be Sleep Management. This module will include basic facts about sleep, with a focus on psychoeducation on insomnia and how the relationship between circadian and social rhythms relate to sleep and mental health. Core Module 4 will be Stress Management. This module will include psychoeducation about stress, worry management, the cultivation of positive psychology, and relaxation techniques such as diaphragmatic breathing and progressive muscle relaxation.

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:

• at least 18 years of age
• Cantonese language fluency and readability
• a PHQ-9 score of at least 10, indicating a moderate level of depression
• current DSM-IV diagnostic criteria of major depressive episode based on the Mini International Neuropsychiatric Interview (MINI)
• 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:

• the presence of other current psychiatric disorders as assessed by the MINI
• 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 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)
• current involvement in lifestyle changes supervised by professionals
• intake of 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

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

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: July 8, 2022
• First Posted: July 12, 2022
• Study Start: January 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

HK (1)