Clinical trial NCT04107519: Goal-Directed Resilience Training to Mitigate Chronic Pain in Former Football Players
Official title: Goal-Directed Resilience Training to Mitigate Chronic Pain in Former Football Players
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic Pain
Resilience
Football Players
Lead sponsor: Morehouse School of Medicine
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
First posted: 2019-09-27
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators propose to test a pilot study that teaches resilience skills to former football players who experience chronic pain. The purpose of this study is to see if learning resilience skills makes a difference in how former players manage chronic pain. This pilot study may advance methods to improve the well-being and quality of life of former players affected by pain.

Detailed description: This pilot study seeks to test the efficacy of a resilience skills training intervention for former football players who experience chronic pain. Chronic pain threatens quality of life, and the culture of elite athletes is poorly adapted to the chronic condition of pain. Innovative strategies that are both culturally acceptable and effective are needed to address the needs of players who may have a reluctance to engage traditional treatment approaches.

The overarching goal is to strengthen the capacity for former football players to maintain adaptive engagement in valued activities despite chronic pain. Responding to recent findings from the Harvard Football Player Health Study (HFPHS) that identified pain as a significant challenge, we propose a pilot study that tests a resilience skills training intervention with former football players who currently experience chronic pain.

This proposed study builds on previous work conducted at Morehouse School of Medicine engaging retired professional football players and ongoing resilience intervention research involving veteran and community-based populations. The specific aim of this study is to test an intervention to decrease chronic pain and co-morbid symptoms and improve a broader adaptive level of functioning through Goal-Directed Resilience Training (GRIT) for chronic pain in a sub-sample of Atlanta-based former players.

The investigators hypothesize the following:

1. GRIT training intervention versus control training will be associated with reduced chronic pain and related symptoms of insomnia, anxiety, depression, improved emotional functions, and improved neurocognitive functions.
2. Improved self-reported physical health, quality of life, personal relationships, and personal growth will be evident for intervention versus control participants.

This pilot study has the potential to advance strategies to improve the well-being and functional status of former players impacted by pain.

Eligibility criteria: Eligibility Criteria

Inclusion Criteria:

* Former football player between 18 - 65 of age
* Player has passed pre-selection and are referred by Harvard Football Players health study
* Potentially diverse racial \& ethnic identities.

Exclusion Criteria:

* Active suicidality or suicidal intent requiring greater than outpatient level of care (Columbia Suicide Severity Rating Scale - CSSRS)
* High risk drinking of alcohol (based on scoring guidelines of AUDIT-C)
* Active psychosis (Psychosis Screener)
* Inability to participate in a small group setting (self-reported inability to regulate constructive social interaction in small group setting
* Inability to meet projected attendance requirements.

Primary outcomes:
measure: Focused Pain-Relevant Measures as measured by Pain Outcome Questionnaire - Short Form
timeFrame: Through study completion, an average of 1 year.
measure: Focused Pain-Relevant Measures as measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form.
timeFrame: Through study completion, an average of 1 year.
measure: Focused Pain-Relevant Measures as measured by Patient-Reported Outcomes Measurement Information System Sleep-Related Impairment Short Form
timeFrame: Through study completion, an average of 1 year.
measure: Focused Pain-Relevant Measures as measured by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form
timeFrame: Through study completion, an average of 1 year.
measure: Focused Pain-Relevant Measures as measured by Pain Catastrophizing Scale (PCS)
timeFrame: Through study completion, an average of 1 year.
measure: Focused Pain-Relevant Measures as measured by Chronic Pain Acceptance Questionnaire
timeFrame: Through study completion, an average of 1 year.
measure: Adaptive Functions Measures as measured by Short Form Health Survey
timeFrame: Through study completion, an average of 1 year.
measure: Adaptive Functions Measures as measured by Psychological Well-being Scale
timeFrame: Through study completion, an average of 1 year.
measure: Adaptive Functions Measures as measured by Hedonic and Eudaimonic Motives for Activities
timeFrame: Through study completion, an average of 1 year.
measure: Adaptive Functions Measures as measured by Patient Health Questionnaire
timeFrame: Through study completion, an average of 1 year.
measure: Adaptive Functions Measures as measured by Generalized Anxiety Disorder Scale
timeFrame: Through study completion, an average of 1 year.
measure: Adaptive Functions Measures as measured by Adverse Childhood Experience Questionnaire
timeFrame: Through study completion, an average of 1 year.
measure: Neurocognitive Measures as measured by Delis-Kaplan Executive Function System
timeFrame: Through study completion, an average of 1 year.
measure: Neurocognitive Measures as measured by Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: Through study completion, an average of 1 year.
measure: Neurocognitive Measures as measured by Neuropsychological Assessment Battery
timeFrame: Through study completion, an average of 1 year.
measure: Resilience Resources for the Unpredictability of Chronic Pain
timeFrame: Through study completion, an average of 1 year.
measure: Physical Functions Measure
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Physiologic measurement of Blood Pressure (BP)
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
Study officials:
affiliation: Cardiovascular Research Institute
name: Herman Taylor, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: