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Compass Course: COVID-19 (CC-COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05295238
Recruitment Status : Active, not recruiting
First Posted : March 25, 2022
Last Update Posted : March 29, 2023
Sponsor:
Information provided by (Responsible Party):
Mary Radomski, Allina Health System

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
COVID-19 Behavioral: Compass Course Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Purpose in Life Renewal for Adults Who Experienced COVID-19 Illness
Actual Study Start Date : March 7, 2022
Actual Primary Completion Date : March 7, 2023
Estimated Study Completion Date : March 7, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05295238


Locations
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United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55447
Sponsors and Collaborators
Allina Health System
Investigators
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Principal Investigator: Mary V Radomski, OTR/L, PhD Allina Health
More Information
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Responsible Party: Mary Radomski, Senior Scientific Advisor, Allina Health System
ClinicalTrials.gov Identifier: NCT05295238    
Other Study ID Numbers: 1860339
First Posted: March 25, 2022    Key Record Dates
Last Update Posted: March 29, 2023
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be made available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mary Radomski, Allina Health System:
Purpose in Life
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases