Clinical trial NCT05295238: Compass Course: COVID-19
Official title: Purpose in Life Renewal for Adults Who Experienced COVID-19 Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Purpose in Life
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change in Psychological Wellbeing
timeFrame: Will be assessed at baseline (week 0) and completion (following session 8, week 12)
Secondary outcomes:
measure: Change in Meaning in Life Questionnaire
timeFrame: Will be assessed at baseline (week 0) and completion (following session 8, week 12)
measure: Change in Purpose Status Question
timeFrame: Will be assessed at baseline (week 0) and completion (following session 8, week 12)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Allina Health
name: Mary V Radomski, OTR/L, PhD
role: PRINCIPAL_INVESTIGATOR
References: