Concussion; SyndromePSCNCT05780658
Feasibility of a Purpose in Life Renewal Intervention for Adults With Persistent Symptoms After Concussion
A study testing Compass Course in people with Concussion; Syndrome, run by Mary Radomski at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Concussion; Syndrome
- What is being tested?
- Compass Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Response to Purpose Status Question (PSQ) suggests that lack of Purpose Direction
- 18 years or older
- Able to communicate in English
- Evidence of persistent concussion symptoms (concussion symptoms that persist at least 3 months after date of concussion) for concussions occurring in the past 2 years
- Received medical-rehabilitative services for persistent concussion symptoms over the past 12 months based on documentation in EPIC (i.e., ICD9 or ICD10 codes) or clinician referral to the study
- Access to computer or tablet and adequate internet connection to participate in video conference
Show all 13Show fewer
- Has an email address
- Has a device (computer with webcam, tablet) to use for Zoom access during sessions
- Has access to an internet connection - broadband wired or wireless (3G or 4G/LTE)
- 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
- Agrees to use personal smartphone to download mEMA application and respond to application notifications (mEMA is described below)
- Agrees to make every effort to attend all group sessions, respond to mEMA notifications many times per week, and to spend 30 minutes each week performing homework
Who cannot join
- Has significant problems in everyday functioning that would interfere with full participation in the intervention, indicated by a WSAS score above 30 during screening (indicative of severe functional pathology [Mundt et al., 2002]).
- Reports being unable to see, hear, or speak (with or without assistive devices)
Trial locations and contacts
1 site in 1 country.
United States1 site
Courage Kenny Research Institute
Minneapolis, Minnesota, 55407
About this study
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.
Read the detailed description
Aim #1: To evaluate the acceptability of the CC intervention (purpose renewal intervention) delivered via HIPAA-compliant Zoom to adults with PSC who report lacking a sense of direction in life. Quantitative measures of acceptability will include number of inquiries to explore study participation; participant intervention completion rate; participant responses to an Experience Survey at posttest. The investigators will also conduct posttest focus groups to assess aspects of the intervention that may need to be modified prior to a larger study.
Aim #2: To determine the extent to which the CC has beneficial effects on psychosocial outcomes (i.e., self-reported purpose in life; functioning; persistent concussion symptoms) for adults with PSC. The investigators will use a one-group, pretest-posttest design collecting pretest, posttest, and 2-month follow-up data. Main outcomes will include self-reported purpose in life (purpose in life subscale of the Scales of Psychological Wellbeing (Ryff \& Keyes, 1995) and Meaning in Life Questionnaire (Steger et al., 2006). Secondary outcomes will include engagement in purpose activities (Life Engagement Test [Scheier et al., 2006]) and concussion symptoms (Rivermead Post Concussion Symptoms Questionnaire [King et al., 1995].
Aim #3: To explore the relationship between participants' real-time responses to purpose prompts delivered via a smartphone app and intervention adherence and outcomes. The investigators will employ mobile ecological momentary assessment to prompt participants to make daily purpose-related choices from the start of the study intervention and evaluate whether participation in these daily prompts is related to primary and secondary outcomes.
- Conditions
- Concussion; Syndrome
- Being tested
- Compass Course
- Medical subject headings
- Brain Concussion, Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compass CourseBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Compass Course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Purpose in Life
Purpose-related subscale of a widely-used self-report questionnaire that was designed to measure 6 theoretically motivated dimensions of psychological well-being
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start8 Mar 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion; SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Radomski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mary Radomski, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780658
- Sponsor's protocol ID
- 2006262
- Acronym
- PSC
- Status last verified
- Jul 2024
- First submitted
- 13 Mar 2023
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Purpose in Life Renewal Intervention for Adults With Persistent Symptoms After Concussion
- ClinicalTrials.gov ID
- NCT05780658
- Acronym / sponsor ID
- PSC / 2006262
- Conditions
- Concussion; Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mary RadomskiUniversity, hospital or other
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Aim #1: To evaluate the acceptability of the CC intervention (purpose renewal intervention) delivered via HIPAA-compliant Zoom to adults with PSC who report lacking a sense of direction in life. Quantitative measures of acceptability will include number of inquiries to explore study participation; participant intervention completion rate; participant responses to an Experience Survey at posttest. The investigators will also conduct posttest focus groups to assess aspects of the intervention that may need to be modified prior to a larger study.
Aim #2: To determine the extent to which the CC has beneficial effects on psychosocial outcomes (i.e., self-reported purpose in life; functioning; persistent concussion symptoms) for adults with PSC. The investigators will use a one-group, pretest-posttest design collecting pretest, posttest, and 2-month follow-up data. Main outcomes will include self-reported purpose in life (purpose in life subscale of the Scales of Psychological Wellbeing (Ryff \& Keyes, 1995) and Meaning in Life Questionnaire (Steger et al., 2006). Secondary outcomes will include engagement in purpose activities (Life Engagement Test [Scheier et al., 2006]) and concussion symptoms (Rivermead Post Concussion Symptoms Questionnaire [King et al., 1995].
Aim #3: To explore the relationship between participants' real-time responses to purpose prompts delivered via a smartphone app and intervention adherence and outcomes. The investigators will employ mobile ecological momentary assessment to prompt participants to make daily purpose-related choices from the start of the study intervention and evaluate whether participation in these daily prompts is related to primary and secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compass Course | Experimental | Behavioral: Compass CourseFour 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Response to Purpose Status Question (PSQ) suggests that lack of Purpose Direction
- 18 years or older
- Able to communicate in English
- Evidence of persistent concussion symptoms (concussion symptoms that persist at least 3 months after date of concussion) for concussions occurring in the past 2 years
- Received medical-rehabilitative services for persistent concussion symptoms over the past 12 months based on documentation in EPIC (i.e., ICD9 or ICD10 codes) or clinician referral to the study
Key exclusion criteria (2 listed)
- Has significant problems in everyday functioning that would interfere with full participation in the intervention, indicated by a WSAS score above 30 during screening (indicative of severe functional pathology [Mundt et al., 2002]).
- Reports being unable to see, hear, or speak (with or without assistive devices)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compass CourseAn 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. | Behavioural | Compass Course |
Primary outcome
Purpose in Life
Time frame: Three months
Purpose-related subscale of a widely-used self-report questionnaire that was designed to measure 6 theoretically motivated dimensions of psychological well-being
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compass Course in people with Concussion; Syndrome, run by Mary Radomski at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Purpose in Life (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.