Clinical trial NCT05454761: Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence
Official title: Effects of Multicomponent Lifestyle Intervention for Depression Supported With Digital Health Technologies to Promote Adherence: A Randomized Controlled Trial and a Process Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Lifestyle Medicine
Depression
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Secondary outcomes:
measure: Change in Insomnia Severity Index (ISI)
timeFrame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
measure: Change in the Health-Promoting Lifestyle Profile (HPLP II)
timeFrame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
measure: Change in the Sheehan Disability Scale (SDS)
timeFrame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
measure: Change in Quality-adjusted Life Years - The Short Form Six-Dimension (SF-6D)
timeFrame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: [Time Frame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed]
Other outcomes:
measure: Change in the Credibility-Expectancy Questionnaire (CEQ)
timeFrame: [Time Frame: Baseline and immediately after treatment]
measure: Treatment Acceptability Scale (TAS)
timeFrame: [Time Frame: Baseline and immediately after treatment]
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: