Compass Course: COVID-19 (CC-COVID)

• ClinicalTrials.gov Identifier: NCT05295238
• Recruitment Status: Active, not recruiting
• First Posted: March 25, 2022
• Last Update Posted: March 29, 2023
• Sponsor: Allina Health System
• Information provided by (Responsible Party): Mary Radomski, Allina Health System

Tracking Information

• First Submitted Date: March 23, 2022
• First Posted Date: March 25, 2022
• Last Update Posted Date: March 29, 2023
• Actual Study Start Date: March 7, 2022
• Actual Primary Completion Date: March 7, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 23, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 23, 2022)

• 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).
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Compass Course: COVID-19
• Official Title: Purpose in Life Renewal for Adults Who Experienced COVID-19 Illness

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: COVID-19

Intervention

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.

Study Arms

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.

Intervention: Behavioral: Compass Course

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 23, 2022): 48
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 7, 2024
• Actual Primary Completion Date: March 7, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05295238
• Other Study ID Numbers: 1860339
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No IPD will be made available.

• Current Responsible Party: Mary Radomski, Allina Health System
• Original Responsible Party: Same as current
• Current Study Sponsor: Allina Health System
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Allina Health System
• Verification Date: March 2022