Clinical trial NCT05780658: Feasibility of a Purpose in Life Renewal Intervention for Adults With Persistent Symptoms After Concussion
Official title: Feasibility of a Purpose in Life Renewal Intervention for Adults With Persistent Symptoms After Concussion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion; Syndrome
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Purpose in Life
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Courage Kenny Research Institute
state: Minnesota
Study officials:
References: