Clinical trial NCT04615741: Finding Wellness in the Pandemic
Official title: Improving Health and Wellness During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Addiction
Stress, Psychological
Covid19
Lead sponsor: University of Lethbridge
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 187
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Non-community dwelling
* Do not currently reside within Alberta, Canada

Primary outcomes:
measure: Changes in Tobacco Use
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Alcohol Use
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Drug Use
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Gambling
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Post-Traumatic Stress Symptoms
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Depression Symptoms
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Anxiety Symptoms
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Secondary outcomes:
measure: Changes in Eating Behaviour
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Sleeping Behaviour
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Physical Activity
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Resilience
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Self-Esteem
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Loneliness
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Dissociative Experiences
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Other outcomes:
measure: Changes in Coping Strategies
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
measure: Changes in Relationships and Belonging
timeFrame: Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up
Locations:
city: Lethbridge
country: Canada
facility: University of Lethbridge
state: Alberta
Study officials:
affiliation: University of Lethbridge
name: Cheryl Currie, PhD
role: PRINCIPAL_INVESTIGATOR
References: