Compass Course: COVID-19

COVID-19 Clinical Trial

— CC-COVID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05295238
• Other study ID #: 1860339
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: March 7, 2024

Study information

• Verified date: March 2022
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: March 7, 2024
• Est. primary completion date: March 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Psychological Wellbeing	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	Change in Meaning in Life Questionnaire	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)
Secondary	Change in Purpose Status Question	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)