Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05780658
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2023-03-13
Brief Title:
Feasibility of a Purpose in Life Renewal Intervention for Adults With Persistent Symptoms After Concussion
Sponsor:
Mary Radomski
Organization:
Allina Health System
Study Overview
Official Title:
Feasibility of a Purpose in Life Renewal Intervention for Adults With Persistent Symptoms After Concussion
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSC
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 eventstransitions 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
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 ie 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
Aim 2 To determine the extent to which the CC has beneficial effects on psychosocial outcomes ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None