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CompletedNCT05295238CC-COVIDUpdated Jul 17, 2024

Compass Course: COVID-19

An interventional study of Compass Course in COVID-19, sponsored by Allina Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by Allina Health System · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • COVID-19

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Keywords

  • Purpose in Life
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
27 participants (actual)

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.

    Behavioral: Compass Course

Interventions

  • BehavioralCompass 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Will be assessed at baseline (week 0) and completion (following session 8, week 12)

Secondary outcomes

  1. 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).

    Time frame: Will be assessed at baseline (week 0) and completion (following session 8, week 12)

  2. 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

    Time frame: Will be assessed at baseline (week 0) and completion (following session 8, week 12)

06

Study locations

1 site
  • Abbott Northwestern Hospital
    Minneapolis, Minnesota 55447, United States
07

References and documents

Individual participant data

Plan to share: No — No IPD will be made available.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05295238
Lead sponsor
Allina Health System
Responsible party
Mary Radomski (Senior Scientific Advisor, Allina Health System) — Principal investigator
First posted
Mar 25, 2022
Start date
Mar 7, 2022
Primary completion
Mar 7, 2023
Completion
Jan 22, 2024
Last update
Jul 17, 2024

Study contacts

Mary V Radomski, OTR/L, PhD
principal investigator · Allina Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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