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临床试验/NCT04875663
NCT04875663Unknown不适用

Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools: A Randomized Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
Change in the Patient Health Questionnaire (PHQ-9)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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
  • •Hospitalization
  • •Current participation in any other trial(s)

研究组 & 干预措施

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.

干预措施: Lifestyle Medicine (Behavioral)

Pure lifestyle medicine intervention

Experimental

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

干预措施: Lifestyle Medicine (Behavioral)

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

结局指标

主要结局

Change in the Patient Health Questionnaire (PHQ-9)

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

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).

次要结局

  • 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 the Sheehan Disability Scale (SDS)(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 International Physical Activities Questionnaire - Chinese version (IPAQ-C)(Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fiona YY Ho

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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