NCT05295238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

March 23, 2022

Last Update Submit

July 16, 2024

Conditions

Keywords

Purpose in Life

Outcome Measures

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.

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

Secondary Outcomes (2)

  • Change in Meaning in Life Questionnaire

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

  • Change in Purpose Status Question

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

Study Arms (1)

Compass Course

EXPERIMENTAL

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

Compass CourseBEHAVIORAL

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.

Compass Course

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55447, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Mary V Radomski, OTR/L, PhD

    Allina Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientific Advisor

Study Record Dates

First Submitted

March 23, 2022

First Posted

March 25, 2022

Study Start

March 7, 2022

Primary Completion

March 7, 2023

Study Completion

January 22, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

No IPD will be made available.

Locations