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

Not Applicable
Completed
Conditions
Concussion; Syndrome
Registration Number
NCT05780658
Lead Sponsor
Mary Radomski
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
22
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Purpose in LifeThree months

Purpose-related subscale of a widely-used self-report questionnaire that was designed to measure 6 theoretically motivated dimensions of psychological well-being

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Courage Kenny Research Institute

🇺🇸

Minneapolis, Minnesota, United States

Courage Kenny Research Institute
🇺🇸Minneapolis, Minnesota, United States

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