Clinical trial NCT04875663: Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools
Official title: Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools: A Randomized Controlled Trial
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: 2021-05-06
Enrollment: 90
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: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Secondary outcomes:
measure: Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
measure: Change in the World Health Organization Quality of Life Instruments (WHOQOL-BREF)
timeFrame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
measure: Change in the Health-Promoting Lifestyle Profile (HPLP II)
timeFrame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
measure: Change in the Sheehan Disability Scale (SDS)
timeFrame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
measure: Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
timeFrame: Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Other outcomes:
measure: Change in the Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Baseline and immediately after treatment
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: