Finding Wellness in the Pandemic

NCT04615741 | Completed

• 1 other identifier: 2020-096
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Changes in Tobacco Use

  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.

  Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

• Changes in Alcohol Use

  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.

  Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

• Changes in Drug Use

  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.

  Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

• Changes in Gambling

  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.

  Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

• Changes in Post-Traumatic Stress Symptoms

  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).

  Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

• Changes in Depression Symptoms

  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).

  Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

• Changes in Anxiety Symptoms

  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.

  Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Secondary Outcomes (7)

• 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 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

Other Outcomes (2)

• Changes in Coping Strategies

  Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

• Changes in Relationships and Belonging

  Baseline, Mid-point (4-weeks), Post-intervention (8-weeks), 3-month Follow Up

Study Arms (3)

Trauma Informed Yoga

EXPERIMENTAL

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

Behavioral: Trauma Informed Yoga

Trauma Informed Psychotherapy

EXPERIMENTAL

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

Behavioral: Trauma Informed Psychotherapy

Control

NO INTERVENTION

These participants will not receive an intervention.

Interventions

Trauma Informed Yoga 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 Yoga

Trauma Informed Psychotherapy 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).

Trauma Informed Psychotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lethbridge: lead

Study Sites (1)

University of Lethbridge

Lethbridge, Alberta, T1K 3M4, Canada

Location

MeSH Terms

Conditions

Behavior, Addictive; Stress, Psychological; COVID-19

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior; Behavioral Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Cheryl Currie, PhD

  University of Lethbridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: November 9, 2020
• Primary Completion: January 22, 2021
• Study Completion: April 20, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: After April 2021, for up to 10 years
• Access Criteria: Researchers must make a reasonable request to the PI

Locations

CA (1)