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

NCT05780658 | Completed

• 1 other identifier: 2006262
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion; Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

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 Course BEHAVIORAL

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Response to Purpose Status Question (PSQ) suggests that lack of Purpose Direction
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mary Radomski: lead

Study Sites (1)

Courage Kenny Research Institute

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Brain Concussion; Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Scientific Advisor

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 22, 2023
• Study Start: March 8, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)