Improving Health and Wellness During COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Changes in Post-Traumatic Stress Symptoms
研究概览
简要总结
There is an immediate need for population-level intervention research to address the impacts of the coronavirus disease 2019 (COVID-19) pandemic and its containment measures on mental health and substance use (MHSU). While online programs are available to address these issues, they are often delivered in an asynchronous format with relatively low therapist or health coaching guidance. As highlighted by a recent systematic review, positive outcomes for online mental health programs are tied to the intensity of therapist or coaching guidance, which increases cost and reduces population access to more effective online options. A way to offset cost while maintaining effectiveness is to offer MHSU programs to groups online, rather than individually. In 2019, the investigators launched an RCT to test gender-stratified group interventions to address MHSU among community-based Indigenous and non-Indigenous adults in southern Alberta. The investigators implemented the interventions with more than 200 adults before the study was paused due to COVID-19.
详细描述
The primary objective of this project is to adapt two existing mental health and substance use interventions and RCT for online delivery, COVID-19 impacts, and province-wide spread. The second objective is to test if an online group body-oriented intervention (trauma-sensitive yoga) that has been designed to increase awareness of physical sensations, is superior to an online group verbal narrative intervention (mental wellness talking circle), and to control group. The investigators theorize that the body-oriented intervention may offer the opportunity to reprogram automatic physiologic hyperarousal in response to COVID-19 triggers and increase positive body awareness, and mindful attention to the ways in which habitual self-protective behaviours like substance use may be impacting health. The third objective is to examine the impacts of the interventions on adults with pre-existing MHSU issues, and those with previous experiences that may make them more susceptible to MHSU problems during COVID-19. The investigators will track other supports the participants engage during the study and the perceived impacts of these supports on the outcomes with the goal of shedding light on how to best match COVID-19 related services to adults who need them the most.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between 18-75 years living in Alberta, Canada
- •Need to have reliable access to the internet, a device with a webcam for the next 2 months
- •Need to self-identify that they are currently struggling with at least one of: stress eating, alcohol use, drug use, tobacco use, or gambling during the pandemic
排除标准
- •Non-community dwelling
- •Do not currently reside within Alberta, Canada
结局指标
主要结局
Changes in Post-Traumatic Stress Symptoms
时间窗: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
A revised version of the Primary Care - Post Traumatic Stress Disorder - 5 (PC-PTSD-5) scale will be assessed to determine experiences of trauma in relation to COVID-19. The scale was revised to specifically ask about COVID-19. Scores range from 0 (no risk) to 5 (high risk). A cut-score of 3 will be used to differentiate high- and low-risk scores. The PC-PTSD has good sensitivity (r = 0.78) and sensitivity (r = 0.87).
Changes in Tobacco Use
时间窗: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Participants will be asked to self-report if tobacco use has changed during the pandemic via a 5-point likert. Options range from increased a lot to decreased a lot. If participants indicate their tobacco use has changed, they will be asked to identify the primary reason for this change. Changes in tobacco use will be re-assessed at each time point.
Changes in Gambling
时间窗: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Gambling will be assessed via the 9-item Problem Gambling Severity Index (PGSI). The items are measured on a 5-point likert with frequencies from "less than once a month" to "daily or almost daily". A cut-score ≥5 will be used (lower scores indicative of non-problem gambling); the PGSI has a high internal consistency (α = 0.86) and is considered the measure of choice for non-clinical use.
Changes in Drug Use
时间窗: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Past year drug use will be assessed through the Drug Use Disorders Identification Test (DUDIT). Possible scores on the DUDIT range from 0 to 44; scores greater than 2 or 6 are indicative of risky or harmful drug habits for women and men, respectively. A score of 25 or more suggests the individual is probably heavily dependent on drugs. Participants will also be asked to identify which drugs they currently use, the main reasons for using drugs, and whether their drug use has changed during the pandemic. Changes in drug use will be re-assessed at each time point.
Changes in Depression Symptoms
时间窗: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Depression will be screened using the 10-item Centre for Epidemiological Studies Depression Scale (CES-D-10). The CES-D-10 is a short self-report scale to measure depressive symptoms in a general population. Psychometric evaluation has shown the CES-D-10 to have high internal consistency, though with variability across populations (Cronbach's α = 0.71 to 0.90) and good construct validity (r = 0.78).
Changes in Alcohol Use
时间窗: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Past year alcohol consumption will be assessed through the Alcohol Use Disorder Identification Test (AUDIT). Scores on the AUDIT range from 0 to 40; a score over 8 is indicative of problematic or hazardous alcohol use. Changes in alcohol consumption since the beginning of the pandemic will be identified through a 5-point likert. Changes in alcohol use will be re-assessed at each time point.
Changes in Anxiety Symptoms
时间窗: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
The 6-item State-Trait Anxiety Inventory (STAI-6) will be used to measure anxiety reflective of both adverse situations (state anxiety) and personality traits associated with higher levels of anxiety (trait anxiety). STAI-6 produces scores like its longer 20-item version, showing good reliability (Cronbach's α = 0.82) with sensitivity to differing degrees of anxiety. Possible scores range from 20 to 80; "normal scores" range from 34 to 36. Higher scores represent higher amount of anxiety.
次要结局
- Changes in Physical Activity(Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up)
- Changes in Resilience(Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up)
- Changes in Self-Esteem(Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up)
- Changes in Eating Behaviour(Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up)
- Changes in Sleeping Behaviour(Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up)
- Changes in Loneliness(Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up)
- Changes in Dissociative Experiences(Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up)
研究者
Cheryl Currie
Associate Professor
University of Lethbridge