RESTORE: An Online Self-directed Mental Health Intervention for Individuals Who Had COVID-19 and Close Others
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Generalized Anxiety Disorder-7 (GAD-7)
研究概览
简要总结
There is considerable need for psychological intervention targeting stressor-related mental health symptoms related to COVID-19. The investigators have developed an online self-directed transdiagnostic intervention to address this need called RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health. The specific aims of this project are to refine and investigate the initial safety, efficacy, and desirability of RESTORE for addressing mental-health symptoms in individuals who have recovered from severe COVID-19 and close others.
详细描述
This uncontrolled pilot interventional study will examine the feasibility and preliminary efficacy of RESTORE. RESTORE is a guided self-directed online intervention to improve anxiety, depression, and posttraumatic stress disorder (PTSD) in individuals exposed to COVID-19 related traumatic or extreme stressors. RESTORE is based on evidence-based psychotherapies and has been designed to overcome many of the barriers associated with accessing evidence-based psychotherapies. The intervention will be iteratively refined over the course of the study. The guidance methods will also be refined over the course of the study
The primary hypotheses are that RESTORE will be safe, feasible, and desirable to participants, and will lead to improvements in mental health symptom severity from baseline to post-intervention. Secondary hypotheses are that RESTORE will lead to significant improvements in perceived health, quality of life, and functioning that will be maintained at one-month follow-up. Participants will be assessed at baseline, pre-intervention, during the intervention (after module 4), immediately after the intervention, and 1 month after completion of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Experienced a traumatic or extremely stressful experience related to being COVID-19+ or having a close other who was COVID-19+
- •Participants who were COVID+ will be eligible once they are no longer exhibiting COVID-19 symptoms and those who were hospitalized will be eligible post-discharge
- •Close others will be eligible once their close other with COVID-19 has recovered or if their loved one is deceased
- •≥ 18 years of age
- •Scores at above clinical threshold on at least one of: Patient Health Questionnaire-9 ([PHQ-9] score ≥ 10), Generalized Anxiety Disorder Scale-7 ([GAD-7] score ≥ 10), and/or Posttraumatic Stress Disorder Scale-5 ([PCL-5] score ≥ 33)
- •Access to a computer or a tablet with high speed internet access, be able to clearly see the screen of a computer or tablet, and be fluent in English
- •Ability to provide consent
排除标准
- •Elevated risk of suicide
- •Currently enrolled in another intervention or treatment (e.g., cognitive behavioural therapy) for stress responses related to the COVID-19 pandemic
结局指标
主要结局
Change in Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
A brief clinical measure to assess anxiety severity. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). A symptom severity score is calculated based on the sum of the 7 items, with scores ranging from 0 to 21. GAD-7 scores of 10 and 15 are the cut-off points for moderate and severe anxiety, respectively (Spitzer et., 2006).
Change in self-reported Post Traumatic Stress Disorder (PTSD) symptoms
时间窗: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
The PTSD Checklist-5 (PCL-5); Weathers, Litz, Keane, Palemeri, Marx, \& Schnurr, 2013) weekly version will provide a measure of change in self-reported PTSD symptoms over the course of intervention. Items are rated from 0 (not at all) to 4 (extremely). Items are summed to create a total score ranging from 0 to 80. A cutoff score of ≥ 33 can be used for screening for PTSD diagnosis (Weathers et al, 2013).
Change in Patient Health Questionnaire-9 (PHQ-9)
时间窗: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
A self-report measure of depression symptoms. Each of the 9 items is rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day). Items are summed to produce a total severity score ranging from 0 to 27, with higher scores indicating greater symptom severity. PHQ-9 scores ≥ 10 are considered indicative of moderate levels of depression (Manea et al., 2011).
次要结局
- Change in Trauma-Related Guilt Inventory (TRGI)(Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up)
- Change in Mental Health Seeking Attitudes/Intention Scale(Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up)
- Change in Adapted Brief Grief Questionnaire(Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up)
- Change in Perceived Health, Functioning, and Quality of Life (QOL)(Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up)
- Change in Perceived emotional social support(Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up)
研究者
Kathryn Trottier
Psychologist and Clinical Program Lead
University Health Network, Toronto