Goal-Directed Resilience Training to Mitigate Chronic Pain in Former Football Players

NCT ID: NCT04107519

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-14
• Study Completion Date: 2023-06-30

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Immediate GRIT (ImT) training intervention

Group Type: EXPERIMENTAL

Goal-Directed Resilience Training

Intervention Type: BEHAVIORAL

This pilot study seeks to test the efficacy of a resilience skills training intervention for former football players who experience chronic pain. Between 20 to 48 eligible and consented participants from the Atlanta area will be identified (with a goal of 40 completing the study). They will undergo a pre-training test session and will then be randomized to either the Immediate GRIT (ImT) training intervention or the Delayed Training (DeT) control. The immediate (ImT) group will be trained for 4 weeks with 2 biweekly sessions. At the end of GRIT training they will be post-tested. The delayed (DeT) group wait during these 4 weeks and do not receive training. At the end of the 4-week waiting period, they will also be post-tested. At this point, they will be offered GRIT training for 4 weeks with 2 biweekly sessions. At the end of their training, they will be given a second post-testing. This process will then be repeated for two additional groups of 5-12 lmT and 5-12 DeT participants.

Delayed Training (DeT) control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Goal-Directed Resilience Training

This pilot study seeks to test the efficacy of a resilience skills training intervention for former football players who experience chronic pain. Between 20 to 48 eligible and consented participants from the Atlanta area will be identified (with a goal of 40 completing the study). They will undergo a pre-training test session and will then be randomized to either the Immediate GRIT (ImT) training intervention or the Delayed Training (DeT) control. The immediate (ImT) group will be trained for 4 weeks with 2 biweekly sessions. At the end of GRIT training they will be post-tested. The delayed (DeT) group wait during these 4 weeks and do not receive training. At the end of the 4-week waiting period, they will also be post-tested. At this point, they will be offered GRIT training for 4 weeks with 2 biweekly sessions. At the end of their training, they will be given a second post-testing. This process will then be repeated for two additional groups of 5-12 lmT and 5-12 DeT participants.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Morehouse School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Herman A. Taylor, MD, MPH, FACC, FAHA

Director, Cardiovascular Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herman Taylor, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Research Institute

Locations

Morehouse School of Medicine

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1341910

Identifier Type: -

Identifier Source: org_study_id