Feasibility of a Purpose in Life Renewal Intervention for Adults With Persistent Symptoms After Concussion

Concussion; Syndrome Clinical Trial

— PSC  

Official title:

Feasibility of a Purpose in Life Renewal Intervention for Adults With Persistent Symptoms After Concussion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780658
• Other study ID #: 2006262
• Status: Recruiting
• Phase: N/A
• Start date: March 8, 2023
• Est. completion date: November 29, 2023

Study information

• Verified date: April 2023
• Source: Allina Health System
• Contact: Maxwell Klaiman
• Phone: 612-863-4088
• Email: Maxwell.Klaiman[@]allina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Concussion; Syndrome

Intervention

Behavioral:
• Compass 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.

Locations

Country	Name	City	State
United States	Courage Kenny Research Institute	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mary Radomski

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Three months