Finding Wellness in the Pandemic

University of Lethbridge

Status: Completed

Conditions: Mental Health Wellness 1; Addiction; Covid19; Stress, Psychological

Treatments: Behavioral: Trauma Informed Yoga; Behavioral: Trauma Informed Psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04615741

2020-096

Details and patient eligibility

About

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.

Full 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.

Enrollment: 187 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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187 participants in 3 patient groups

Trauma Informed Yoga

Experimental group

Description:

Participants will receive 8 x 60 min group-based yoga sessions, delivered synchronously over Zoom.

Treatment:

Behavioral: Trauma Informed Yoga

Trauma Informed Psychotherapy

Experimental group

Description:

Participants will receive 8 x 90 min group-based psychotherapy sessions, delivered synchronously over Zoom.

Treatment:

Behavioral: Trauma Informed Psychotherapy

Control

No Intervention group

Description:

These participants will not receive an intervention.