Chronic PainNCT04107519
Goal-Directed Resilience Training to Mitigate Chronic Pain in Former Football Players
A study testing Goal-Directed Resilience Training in people with Chronic Pain, run by Morehouse School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Goal-Directed Resilience Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Morehouse School of Medicine
Atlanta, Georgia, 30310
About this study
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.
Read the 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:
- 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.
- 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
- Being tested
- Goal-Directed Resilience Training
- Keywords
- Chronic Pain, Resilience, Football Players
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Directed Resilience TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate GRIT (ImT) training intervention | Experimental | Not described Receives: Behavioral: Goal-Directed Resilience Training |
| Delayed Training (DeT) control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Focused Pain-Relevant Measures as measured by Pain Outcome Questionnaire - Short Form
Changes in pre-to-post scores for severity of pain among intervention versus control group as measured by the Pain Outcome Questionnaire. It measures severity of pain with 20 items and 6 subscales. Total range: 0-150 [20 Likert items; item range: 0-10]
Subscales:
Pain Intensity: 0-10 (1 item) Mobility: 0-40 (sum of 4 items) Activities of Daily Living: 0-40 (sum of 4 items) Vitality: 0 (30 minus sum of 3 items with maximum score of 10 points per item, thus 30-30=0) Negative Affect: 0-50 (sum of 5 items) Fear : 0-10 (10 minus item #18 = 0) with maximum score of 10 point for #19 Highest values = worst intensity, worst mobility, worst Activities of Daily Living, highest impaired vitality, highest negative affect, highest pain-related fear Total score: the above subscale scores are summed
Measured: Through study completion, an average of 1 year.
Focused Pain-Relevant Measures as measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form.
Changes in pre-to-post scores among intervention versus control group as measured by the Patient-Reported Outcomes Measurement Information System Pain Interference Short Form. Scale measures the extent to which pain interferes in various activities.
Total range: 8-40 (raw score) 8 Likert items, item range = 1-5 No subscales Higher value is worse pain interference No subscales. Total raw scores is converted to t-scores.
Measured: Through study completion, an average of 1 year.
Focused Pain-Relevant Measures as measured by Patient-Reported Outcomes Measurement Information System Sleep-Related Impairment Short Form
Changes in pre-to-post scores among intervention versus control group as measured by Patient-Reported Outcomes Measurement Information System Sleep-Related Impairment Short Form. Measures perception of alertness, sleepiness, tiredness during waking hours.
Total range: 8-40 raw score 8 Likert items; item range = 1-5 No subscales Higher value is worse sleep-related impairment No subscales. Total raw scores is converted to t-scores that are listed in a table in the manual.
Measured: Through study completion, an average of 1 year.
Focused Pain-Relevant Measures as measured by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form
Changes in pre-to-post scores among intervention versus control group as measured by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form. Total range: 8-40 8 Likert items, item range = 1-5 No subscales Higher value is worse sleep disturbance No subscales. Total raw scores is converted to t-scores that is listed in a table in the manual
Measured: Through study completion, an average of 1 year.
Focused Pain-Relevant Measures as measured by Pain Catastrophizing Scale (PCS)
Changes in pre-to-post scores among intervention versus control group as measured by Pain Catastrophizing Scale (PCS). It measures fear and anxiety of pain, with 13 items Total range: 0-52 13 Likert items, item range = 0-4 No subscales Highest value = worst fear \& anxiety No subscales
Measured: Through study completion, an average of 1 year.
Focused Pain-Relevant Measures as measured by Chronic Pain Acceptance Questionnaire
Changes in pre-to-post scores among intervention versus control group as measured by Chronic Pain Acceptance Questionnaire. It measures the acceptance of having chronic pain.
Total range: 0-48 [8 Likert items, item range = 0-6] Subscale: Pain Willingness: 0-24 (4 items, sum of reverse scored items are: 2, 4, 7, 8) Subscale: Activity Engagement: 0-24 (4 items, sum of items 1, 3, 5, 6) Highest value=most acceptance of having chronic pain The two subscales are summed for a total score
Measured: Through study completion, an average of 1 year.
Adaptive Functions Measures as measured by Short Form Health Survey
Changes in pre-to-post scores among intervention versus control group as measured by Short Form Health Survey. Total range: There is no total range. All item scores of the 8 subscales are converted to scores of 0-100 according to instructions. For each subscale these are averaged, resulting in a percentage score. Highest values are the best level of functioning for subscales: physical functioning, emotional well-being, social functioning, and general health. Highest Values are also the best level of functioning for: role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, and pain.
Measured: Through study completion, an average of 1 year.
Adaptive Functions Measures as measured by Psychological Well-being Scale
Changes in pre-to-post scores among intervention versus control group as measured by Psychological Well-being Scale. Used 2 subscales listed below Subscale: Positive Relations with others It evaluates the extend of positive relations someone has with others. Subscale: Personal Growth It evaluates the extent to which someone values personal growth and development Total range: - the total test is not used
Subscale range for each subscale is: 7-42 [7 Likert items; item range 1-6 for each subscale] Higher value is having or valuing highly positive relations with others, and valuing highly and seeking personal growth Positive Relations with Others: reverse scored items are 2, 3, 6. After scores are reversed, the scores for the seven items are summed.
Personal Growth: reverse scored items are 1, 3, 5. After scores are reversed, the scores for the seven items are summed.
Measured: Through study completion, an average of 1 year.
Adaptive Functions Measures as measured by Hedonic and Eudaimonic Motives for Activities
Changes in pre-to-post scores among intervention versus control group as measured by Hedonic and Eudaimonic Motives for Activities. This scale assesses the extent to which someone values happiness and pleasure versus seeking self-growth.
Total range: 9-63 [9 Likert items, item range 1-7] Hedonia subscale: 5-35 Eudaimonia subscale: 4-28 Hedonia subscale: higher value means valuing and seeking happiness and pleasure Eudaimonia subscale: higher value means seeking self-development and being the best a person can be Subscales are not combined but sand alone. Hedonia subscale: consists of 5 items: 1, 4, 6, 7, 9. To obtain a score, item scores are summed Eudaimonia subscale: consists of 4 items: 2, 3, 5, 8. To obtain a score, item scores are summed.
Measured: Through study completion, an average of 1 year.
Adaptive Functions Measures as measured by Patient Health Questionnaire
Changes in pre-to-post scores among intervention versus control group as measured by Patient Health Questionnaire. This scale measures the extent to which someone feels depressed Total range: 0-27 [9 Likert items, item range 0-3] No subscale High value is worse depression No subscales To obtain a total score, the 9 item scores are summed
Measured: Through study completion, an average of 1 year.
Adaptive Functions Measures as measured by Generalized Anxiety Disorder Scale
Changes in pre-to-post scores among intervention versus control group as measured by Generalized Anxiety Disorder Scale This scale measures the extent to which someone feels anxious or fearful Total range: 0-21 [7 Likert items, item range 0-3] No subscale Higher value is worse or high level of anxiety No subscales To obtain a total score, the 7 item scores are summed
Measured: Through study completion, an average of 1 year.
Adaptive Functions Measures as measured by Adverse Childhood Experience Questionnaire
Changes in pre-to-post scores among intervention versus control group as measured by Adverse Childhood Experience Questionnaire This measures the extent to which someone has experienced adversities in poor treatment, family disruption, abuse, etc. during childhood Total range: 0-10 [10 Yes No questions, Yes=1, No=0] No subscales Higher value is higher and more experience of childhood adversity and abuse No subscales To obtain a total score, the 10 items are summed
Measured: Through study completion, an average of 1 year.
Neurocognitive Measures as measured by Delis-Kaplan Executive Function System
Changes in pre-to-post scores among intervention versus control group as measured by Delis-Kaplan Executive Function System. This battery measures neuropsychological executive functions or complex aspects of reasoning. Individual test scores are frequency counts of correct responses or length of time on the items of subscale, and frequency of errors. Verbal Fluency Test = higher value is better verbal fluency Color-Word Interference Test = higher score on time taken to complete is worse performance. Verbal Fluency Test consists of 4 sub-tests that stand alone: Letter Fluency, Category Fluency, Category Switching Total Correct, Category Switching Accuracy.
Measured: Through study completion, an average of 1 year.
Neurocognitive Measures as measured by Repeatable Battery for the Assessment of Neuropsychological Status
Changes in pre-to-post scores among intervention versus control group as measured by Repeatable Battery for the Assessment of Neuropsychological Status Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) This battery assesses a range of neurocognitive functions, including learning, episodic memory, working memory, complex attention.
Total range: There is no total range, just individual test ranges. Individual test range: individual test scores are frequency counts of correct responses or length of time taken for one subtest. There is no range.
Higher correct performance scores are better. Higher scores for taking more time are worse.
Several tests from this battery are used. These stand alone:
List Learning, Story Memory, Digit Span, Coding, List Recall, List Recognition, Story Recall. For each test the raw performance is summed and recorded and a scaled score that is found in the manual is also recorded.
Measured: Through study completion, an average of 1 year.
Neurocognitive Measures as measured by Neuropsychological Assessment Battery
Changes in pre-to-post scores among intervention versus control group as measured by Neuropsychological Assessment Battery This is a comprehensive battery that assesses a wide range of neurocognitive functions.
Total range: There is no total range, just individual test range. Individual test range: individual test range is the frequency counts of correct responses. Also counted are perseverative errors. There is no range.
Higher value of summed correct responses is better. Higher value of perseverative errors is worse. One sub-test is used from this battery: Word Generation. It stands alone. Total sub-test score is the number of correct words generated. Perseverative errors are total number of errors committed.
Measured: Through study completion, an average of 1 year.
Resilience Resources for the Unpredictability of Chronic Pain
Changes in pre-to-post scores among intervention versus control group. This scale consists of two subscales that measure the unpredictability of pain and resilient responses to pain comprised of engagement in activities, cultivating social relations, and pursuing self-growth.
Unpredictability of Chronic Pain covers inability to predict when the person will be in pain, how long it will last, how much person could not plan his activities, how much it interfered in relationships. The size of the score on this subscale will indicate the size of unpredictability of pain Resilience Resources cover three domains: (1) engagement with interest, curiosity, appreciation, noticing beauty in activities despite pain (2) pursuing relationships in showing empathy, helping, friendship, compassion (3) self-growth to pursue excellence, to grow as a person, to learn new skills to improve oneself.
Measured: Through study completion, an average of 1 year.
Physical Functions Measure
Time Measure of Walking. The Six minute walk test is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Physiologic measurement of Blood Pressure (BP)
Changes in pre-to-post scores for blood pressure among intervention versus control group. The auscultatory method of BP measurement with a properly calibrated and validated instrument will be used. Patients will be seated quietly for at least 5 minutes in a chair rather than on an examination table, with feet on the floor and arm supported at heart level. An appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) will be used to ensure accuracy. At least 2 measurements will be made. Systolic BP is the point at which the first of 2 or more sounds is heard (phase 1) and diastolic BP is the point before the disappearance of sounds (phase 5).
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start14 Aug 2019
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morehouse School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Principal investigator, Herman A. Taylor, MD, MPH, FACC, FAHA, Morehouse School of Medicine
- Investigators
- Herman Taylor, MD, MPH, Principal investigator, Cardiovascular Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107519
- Sponsor's protocol ID
- 1341910
- Status last verified
- Aug 2022
- First submitted
- 27 Jun 2019
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Goal-Directed Resilience Training to Mitigate Chronic Pain in Former Football Players
- ClinicalTrials.gov ID
- NCT04107519
- Acronym / sponsor ID
- 1341910
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Resilience, Football Players
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Morehouse School of MedicineUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate GRIT (ImT) training intervention | Experimental | Behavioral: Goal-Directed Resilience Training |
| Delayed Training (DeT) control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-Directed Resilience TrainingThis 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. | Behavioural | Immediate GRIT (ImT) training intervention |
Primary outcome
Focused Pain-Relevant Measures as measured by Pain Outcome Questionnaire - Short Form
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores for severity of pain among intervention versus control group as measured by the Pain Outcome Questionnaire. It measures severity of pain with 20 items and 6 subscales. Total range: 0-150 [20 Likert items; item range: 0-10] Subscales: Pain Intensity: 0-10 (1 item) Mobility: 0-40 (sum of 4 items) Activities of Daily Living: 0-40 (sum of 4 items) Vitality: 0 (30 minus sum of 3 items with maximum score of 10 points per item, thus 30-30=0) Negative Affect: 0-50 (sum of 5 items) Fear : 0-10 (10 minus item #18 = 0) with maximum score of 10 point for #19 Highest values = worst intensity, worst mobility, worst Activities of Daily Living, highest impaired vitality, highest negative affect, highest pain-related fear Total score: the above subscale scores are summed
Focused Pain-Relevant Measures as measured by Patient-Reported Outcomes Measurement Information System Pain Interference Short Form.
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by the Patient-Reported Outcomes Measurement Information System Pain Interference Short Form. Scale measures the extent to which pain interferes in various activities. Total range: 8-40 (raw score) 8 Likert items, item range = 1-5 No subscales Higher value is worse pain interference No subscales. Total raw scores is converted to t-scores.
Focused Pain-Relevant Measures as measured by Patient-Reported Outcomes Measurement Information System Sleep-Related Impairment Short Form
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Patient-Reported Outcomes Measurement Information System Sleep-Related Impairment Short Form. Measures perception of alertness, sleepiness, tiredness during waking hours. Total range: 8-40 raw score 8 Likert items; item range = 1-5 No subscales Higher value is worse sleep-related impairment No subscales. Total raw scores is converted to t-scores that are listed in a table in the manual.
Focused Pain-Relevant Measures as measured by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form. Total range: 8-40 8 Likert items, item range = 1-5 No subscales Higher value is worse sleep disturbance No subscales. Total raw scores is converted to t-scores that is listed in a table in the manual
Focused Pain-Relevant Measures as measured by Pain Catastrophizing Scale (PCS)
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Pain Catastrophizing Scale (PCS). It measures fear and anxiety of pain, with 13 items Total range: 0-52 13 Likert items, item range = 0-4 No subscales Highest value = worst fear \& anxiety No subscales
Focused Pain-Relevant Measures as measured by Chronic Pain Acceptance Questionnaire
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Chronic Pain Acceptance Questionnaire. It measures the acceptance of having chronic pain. Total range: 0-48 [8 Likert items, item range = 0-6] Subscale: Pain Willingness: 0-24 (4 items, sum of reverse scored items are: 2, 4, 7, 8) Subscale: Activity Engagement: 0-24 (4 items, sum of items 1, 3, 5, 6) Highest value=most acceptance of having chronic pain The two subscales are summed for a total score
Adaptive Functions Measures as measured by Short Form Health Survey
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Short Form Health Survey. Total range: There is no total range. All item scores of the 8 subscales are converted to scores of 0-100 according to instructions. For each subscale these are averaged, resulting in a percentage score. Highest values are the best level of functioning for subscales: physical functioning, emotional well-being, social functioning, and general health. Highest Values are also the best level of functioning for: role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, and pain.
Adaptive Functions Measures as measured by Psychological Well-being Scale
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Psychological Well-being Scale. Used 2 subscales listed below Subscale: Positive Relations with others It evaluates the extend of positive relations someone has with others. Subscale: Personal Growth It evaluates the extent to which someone values personal growth and development Total range: - the total test is not used Subscale range for each subscale is: 7-42 [7 Likert items; item range 1-6 for each subscale] Higher value is having or valuing highly positive relations with others, and valuing highly and seeking personal growth Positive Relations with Others: reverse scored items are 2, 3, 6. After scores are reversed, the scores for the seven items are summed. Personal Growth: reverse scored items are 1, 3, 5. After scores are reversed, the scores for the seven items are summed.
Adaptive Functions Measures as measured by Hedonic and Eudaimonic Motives for Activities
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Hedonic and Eudaimonic Motives for Activities. This scale assesses the extent to which someone values happiness and pleasure versus seeking self-growth. Total range: 9-63 [9 Likert items, item range 1-7] Hedonia subscale: 5-35 Eudaimonia subscale: 4-28 Hedonia subscale: higher value means valuing and seeking happiness and pleasure Eudaimonia subscale: higher value means seeking self-development and being the best a person can be Subscales are not combined but sand alone. Hedonia subscale: consists of 5 items: 1, 4, 6, 7, 9. To obtain a score, item scores are summed Eudaimonia subscale: consists of 4 items: 2, 3, 5, 8. To obtain a score, item scores are summed.
Adaptive Functions Measures as measured by Patient Health Questionnaire
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Patient Health Questionnaire. This scale measures the extent to which someone feels depressed Total range: 0-27 [9 Likert items, item range 0-3] No subscale High value is worse depression No subscales To obtain a total score, the 9 item scores are summed
Adaptive Functions Measures as measured by Generalized Anxiety Disorder Scale
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Generalized Anxiety Disorder Scale This scale measures the extent to which someone feels anxious or fearful Total range: 0-21 [7 Likert items, item range 0-3] No subscale Higher value is worse or high level of anxiety No subscales To obtain a total score, the 7 item scores are summed
Adaptive Functions Measures as measured by Adverse Childhood Experience Questionnaire
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Adverse Childhood Experience Questionnaire This measures the extent to which someone has experienced adversities in poor treatment, family disruption, abuse, etc. during childhood Total range: 0-10 [10 Yes No questions, Yes=1, No=0] No subscales Higher value is higher and more experience of childhood adversity and abuse No subscales To obtain a total score, the 10 items are summed
Neurocognitive Measures as measured by Delis-Kaplan Executive Function System
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Delis-Kaplan Executive Function System. This battery measures neuropsychological executive functions or complex aspects of reasoning. Individual test scores are frequency counts of correct responses or length of time on the items of subscale, and frequency of errors. Verbal Fluency Test = higher value is better verbal fluency Color-Word Interference Test = higher score on time taken to complete is worse performance. Verbal Fluency Test consists of 4 sub-tests that stand alone: Letter Fluency, Category Fluency, Category Switching Total Correct, Category Switching Accuracy.
Neurocognitive Measures as measured by Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Repeatable Battery for the Assessment of Neuropsychological Status Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) This battery assesses a range of neurocognitive functions, including learning, episodic memory, working memory, complex attention. Total range: There is no total range, just individual test ranges. Individual test range: individual test scores are frequency counts of correct responses or length of time taken for one subtest. There is no range. Higher correct performance scores are better. Higher scores for taking more time are worse. Several tests from this battery are used. These stand alone: List Learning, Story Memory, Digit Span, Coding, List Recall, List Recognition, Story Recall. For each test the raw performance is summed and recorded and a scaled score that is found in the manual is also recorded.
Neurocognitive Measures as measured by Neuropsychological Assessment Battery
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group as measured by Neuropsychological Assessment Battery This is a comprehensive battery that assesses a wide range of neurocognitive functions. Total range: There is no total range, just individual test range. Individual test range: individual test range is the frequency counts of correct responses. Also counted are perseverative errors. There is no range. Higher value of summed correct responses is better. Higher value of perseverative errors is worse. One sub-test is used from this battery: Word Generation. It stands alone. Total sub-test score is the number of correct words generated. Perseverative errors are total number of errors committed.
Resilience Resources for the Unpredictability of Chronic Pain
Time frame: Through study completion, an average of 1 year.
Changes in pre-to-post scores among intervention versus control group. This scale consists of two subscales that measure the unpredictability of pain and resilient responses to pain comprised of engagement in activities, cultivating social relations, and pursuing self-growth. Unpredictability of Chronic Pain covers inability to predict when the person will be in pain, how long it will last, how much person could not plan his activities, how much it interfered in relationships. The size of the score on this subscale will indicate the size of unpredictability of pain Resilience Resources cover three domains: (1) engagement with interest, curiosity, appreciation, noticing beauty in activities despite pain (2) pursuing relationships in showing empathy, helping, friendship, compassion (3) self-growth to pursue excellence, to grow as a person, to learn new skills to improve oneself.
Physical Functions Measure
Time frame: Through study completion, an average of 1 year.
Time Measure of Walking. The Six minute walk test is a practical simple test that requires a 100-ft hallway but no exercise equipment or advanced training for technicians. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes. It evaluates the global and integrated responses of all the systems involved during exercise, including the pulmonary and cardiovascular systems, systemic circulation, peripheral circulation, blood, neuromuscular units, and muscle metabolism.
1 secondary outcome
Physiologic measurement of Blood Pressure (BP)
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herman Taylor, MD, MPH principal investigator
Cardiovascular Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Directed Resilience Training in people with Chronic Pain, run by Morehouse School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focused Pain-Relevant Measures as measured by Pain Outcome Questionnaire - Short Form (time frame: Through study completion, an average of 1 year.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.