Finding Wellness in the Pandemic

NCT ID: NCT04615741

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-09
• Study Completion Date: 2021-04-20

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trauma Informed Yoga

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

Group Type: EXPERIMENTAL

Trauma Informed Yoga

Intervention Type: BEHAVIORAL

One licensed yoga instructor, trained in trauma-informed yoga delivery, will lead the online sessions. Participants will be instructed to engage in the class from a mat or chair in their home or move between them as the class unfolds. The instructor will begin the class by introducing the week's theme (e.g. grounding and safety, non-attachment, imprints of the past and impacts on our reactions to COVID-19, connection to nature), followed by a breath practice (10 min), a yoga practice (50 min), a meditation practice (10 min), and closing words (10 min).

Trauma Informed Psychotherapy

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

Group Type: EXPERIMENTAL

Trauma Informed Psychotherapy

Intervention Type: BEHAVIORAL

Two licensed counsellors (MSW-trained) will co-facilitate the online version of this program. Facilitators will begin the session by introducing the week's theme (e.g. setting goals while working from home, being mindful, health coping) (10 min), followed by a lecture and activity to integrate learning (e.g. large and small group discussion using Zoom break out rooms, journaling) (70 min), and closing words (10 min).

Control

These participants will not receive an intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Trauma Informed Yoga

One licensed yoga instructor, trained in trauma-informed yoga delivery, will lead the online sessions. Participants will be instructed to engage in the class from a mat or chair in their home or move between them as the class unfolds. The instructor will begin the class by introducing the week's theme (e.g. grounding and safety, non-attachment, imprints of the past and impacts on our reactions to COVID-19, connection to nature), followed by a breath practice (10 min), a yoga practice (50 min), a meditation practice (10 min), and closing words (10 min).

Intervention Type: BEHAVIORAL

Trauma Informed Psychotherapy

Two licensed counsellors (MSW-trained) will co-facilitate the online version of this program. Facilitators will begin the session by introducing the week's theme (e.g. setting goals while working from home, being mindful, health coping) (10 min), followed by a lecture and activity to integrate learning (e.g. large and small group discussion using Zoom break out rooms, journaling) (70 min), and closing words (10 min).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lethbridge

OTHER

Sponsor Role: lead

Responsible Party

Cheryl Currie

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheryl Currie, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lethbridge

Locations

University of Lethbridge

Lethbridge, Alberta, Canada

Countries

Canada

Other Identifiers

2020-096

Identifier Type: -

Identifier Source: org_study_id