Compass Course: COVID-19 (CC-COVID)

March 27, 2023 updated by: Mary Radomski, Allina Health System

Purpose in Life Renewal for Adults Who Experienced COVID-19 Illness

A group of clinicians and researchers developed an 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention, called the Compass Course is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in their daily lives. Participating in this research will involve an introduction session, where informed consent will be obtained, followed by the 8-session intervention for 9 sessions in total.

A team composed of researchers from Courage Kenny Rehabilitation Institute (CKRI) propose to recruit a convenience sample of individuals who were hospitalized with COVID-19 to evaluate the efficacy of administering the Compass Course to a novel population, to improve psychological well-being, engagement in everyday activities, and purpose in life.

A focus group will be scheduled 2 months after the completion of the Compass Course. This session is composed of brief questionnaires and designed to obtain post-course data to help evaluate the Compass Course intervention.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55447
        • Abbott Northwestern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 - 80 years of age;
  • Are part of the Allina Health COVID Research Registry or are receiving/have received therapy services for COVID-19 related sequelae at CKRI;
  • English speaking
  • Graduated from high school
  • Able to see, hear, speak (with or without assistive devices)
  • Access to computer or tablet and adequate internet connection to participate in video conference
  • Has an email address;
  • Own a smartphone with one of the following operating system versions:

iOS 9.0 - 9.3, 10.0 - 10.3, 12, 13.3, 13.7, 14.0 - 14.4 or later Android 8.0 - 8.1.0, 9, 10, 11 or later

  • Agree to use personal smartphone to download mEMA application and respond to application notifications (mEMA is described in Sections 3.2.3.1 and 3.2.4.2.2);
  • Willing and able to commit to attend all intervention sessions

Exclusion Criteria:

  • History of neurologic disorder (such as stroke or brain injury) with residual impairments that likely interfere with learning;
  • Any medical condition (physical or mental health) that interferes with the performance of everyday activities and roles.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Compass Course
Four groups of up to 12 participants (48 total) will receive the study intervention during Spring and Fall 2022. All participants will complete study questionnaires before and after the sessions.
Behavioral: Compass Course
An 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention, called the Compass Course is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in their daily lives.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Psychological Wellbeing
Time Frame: Will be assessed at baseline (week 0) and completion (following session 8, week 12)
Using the Psychological Scales of Wellbeing questionnaire (Ryff, 1989; Ryff, & Keyes, 1995), psychological wellbeing pre- and post- intervention will be tracked.
Will be assessed at baseline (week 0) and completion (following session 8, week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Meaning in Life Questionnaire
Time Frame: Will be assessed at baseline (week 0) and completion (following session 8, week 12)
Meaning in Life Questionnaire (Steger et al., 2006): A 10-item questionnaire designed to measure 2 dimensions of meaning in life: Presence of Meaning (how much respondents feel their lives have meaning) and Search for Meaning (how much respondents strive to find meaning and understanding in their lives).
Will be assessed at baseline (week 0) and completion (following session 8, week 12)
Change in Purpose Status Question
Time Frame: Will be assessed at baseline (week 0) and completion (following session 8, week 12)
Purpose Status Question (PSQ) is a one-item questionnaire designed by the study team to measure participants' current purpose status
Will be assessed at baseline (week 0) and completion (following session 8, week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allina Health System

Investigators

  • Principal Investigator: Mary V Radomski, OTR/L, PhD, Allina Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2022

Primary Completion (Actual)

March 7, 2023

Study Completion (Anticipated)

March 7, 2024

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

March 23, 2022

First Posted (Actual)

March 25, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1860339

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be made available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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