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G.R.I.T. - Goal-directed Resilience Intervention Training (GRIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890029
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Kisha Holden, PhD, MSCR, Morehouse School of Medicine

Brief Summary:

This research program has addressed three reactive adaptations evident in pain, PTSD, and obesity. In this project, the focus will be on PTSD as a model of stimulus-based reactive responses to unpredictability or threat, and the investigators propose to test the efficacy of the goal-directed skills training (GRIT) program for restoring predictive responding and homeostasis. The challenge of how best to cultivate psychological resilience in the face of stress, trauma, and social adversity among disadvantaged populations is a complex question best answered with a translational research approach. This research' intent is to help African American women who are dealing with stress after traumatic experiences. It will specifically study Post-traumatic Stress Disorder, a disorder that affects people who have experienced severe traumas. It is associated with a number of overwhelming emotional symptoms. These include sleep difficulties, depression and anxiety, flashbacks and nightmares of the traumatic events.

The training is an 8-week skill building program that helps people use positive experiences from their past to cope with current difficulties. The investigators will collect blood samples for future research to understand how the body's stress response changes as a result of this training


Condition or disease Intervention/treatment Phase
Chronic Post-Traumatic Stress Disorder Behavioral: Intervention Training Behavioral: Control Condition Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Building Biobehavioral Goal-Directed Resilience Training Among African American Women (Project Grit)
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 21, 2022
Estimated Study Completion Date : August 21, 2029

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention

Once potential participants have given consent and determined eligible, they will undergo an initial assessment.Pre, post- and follow-up testing. This consists of verbal scales including emotional well-being scales and mental health symptom scales. They will be administered in a group 30-60 minute session. Neuropsychological testing and psychophysiological tests given will require 90 minutes. Neuropsychological testing will be completed at pre and post testing only. In order to ensure unbiased assessment, pre- and post- and follow-up testing will be conducted by individuals blinded to study condition.

Randomization. After pre-testing, all individuals will be randomly assigned to either the active treatment group or minimal attention control condition. After this, intervention participants will meet in small groups of 10 per group for 90 minutes/week over five weeks for resilience training. After five weeks, all participants will be post-tested.

Behavioral: Intervention Training
After pre-testing and randomization, intervention participants will meet in small groups of 10 per group for 90 minutes/week over five weeks for resilience training. Participants needing extra help will receive it at the end of each session. Controls will be on a minimal attention list, not being trained. After five weeks, all participants will be post-tested.

Control
While intervention participants receive resilience training, the control group will not receive training but will receive minimal attention of a bi-monthly telephone call to indicate to participants that they are still enrolled in the study. A monthly flyer will be mailed to them about wellness and PTSD in recent news coverage. Following completion of an intervention group, participants and controls will be scheduled for post-testing that will be identical to the pre-testing and will occur within two weeks after the final treatment session. After the post-testing and 3-month follow up testing, the controls will be offered the resilience training
Behavioral: Control Condition
While intervention participants receive resilience training, the control group will not receive training but will receive minimal attention of a bi-monthly telephone call to indicate to participants that they are still enrolled in the study. A monthly flyer will be mailed to them about wellness and PTSD in recent news coverage. Following completion of an intervention group, participants and controls will be scheduled for post-testing that will be identical to the pre-testing and will occur within two weeks after the final treatment session. After the post-testing and 3-month follow up testing, the controls will be offered the resilience training.




Primary Outcome Measures :
  1. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Clinician Administered PTSD Scale for DSM 5 (CAPS-5): clinician-administered, structured interview ideal for screening, differential diagnosis & confirmation of PTSD. Each item is scored on a scale of 0-4; the total composite score range is 0-212; Lower score = better outcome

  2. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the PTSD Checklist (PCL-5): 17-item self-report checklist of PTSD symptoms; General civilian version of the PCL will be used. Each item is scored on a scale of 0-4; the total composite score range is 0-80; Lower score = better outcome

  3. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Posttraumatic Cognitions Inventory (PTCI): 36-item self-report measure assessing trauma-related thoughts and beliefs about self, others, and self-blame. Each item is scored on a scale of 1-7; the total composite score range is 33-231; Lower score = better outcome

  4. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Difficulties in Emotion Regulation: 36-item self-report questionnaire designed to assess multiple aspects of emotion dysregulation. Each item is scored on a scale of 1-5; the total composite score range is 36-180; Lower score = better outcome

  5. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Positive & Negative Affective Schedule (PANAS): 20-item self-report measure frequently used as a measure of general affective states. Each item is scored on a scale of 1-5; the total composite score range is 20-100; 1=very slightly or not at all; 5=extremely; measures positive and negative affect mood scales; higher scores on positive affective scale and lower scores on negative affective scale indicate better outcome

  6. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Ryff Scales of Psychological Well-being: Measures aspects of psychological well-being across three selected subscales: Personal Growth, Positive Relations with Others, Purpose in Life; 9 items each. Each item is scored on a scale of 1-7; the total composite score range is 7-42; Higher score = better outcome

  7. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Conner-Davidson Resilience Scale (CD-RISC): Unidimensional self-reported scale consisting of 10 items measuring resilience. Each item is scored on a scale of 0-4; the total composite score range is 0-100; Higher score = better outcome

  8. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): Originally designed to identify and characterize mild and severe dementia in older adults, later modified to include younger adults. This study will focus on immediate memory, delayed memory, simple and complex attention subtests. In the Immediate memory subset the participant is asked to recall words from a list immediately after being read to her/him; More words remembered = better outcome. In the Delayed memory subset the participant asked to recall words from a list some time after being read to her/him; More words remembered = better outcome, In the Simple attention subset the participant is asked to repeat increasingly longer sequences of digits; More/longer sequences remembered = better outcome. In the Complex attention subset the participant matches symbols with numbers; More correct matches = better outcome.

  9. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Delis-Kaplan Executive Function System (D-KEFS): Study focuses on two of nine subtests (Verbal Fluency and Color-Word Interference) assessing components of executive functioning. In the Verbal Fluency subset the participant says words that begin with a specified letter, belong to a designated semantic category, and alternate between saying words from two different semantic categories; More words participant can say per category = better outcome. In the Color-Word Interference subset the participant names color patches, reads words naming colors printed in black ink, names the ink color in which color words are printed in an incompatible ink color, and switches back and forth between naming the dissonant ink color and reading the conflicting words; More accurate = better outcome.

  10. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by demographics: Collected demographic data will include age, gender, race, etc. Each item is scored on a scale of 0-3; the total composite score range is 0-66; Lower score=better outcome.

  11. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Beck Depression Inventory (BDI): reflects DSM criteria for depression, score indicates presence of minimal, mild, moderate, or severe depressive symptoms. Each item is scored on a scale of 0-3; the total composite score range is 0-66; Lower score=better outcome.

  12. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Patient Health Questionnaire Depression Scale (PHQ-9): 9-item measure reflecting DSM criteria for depression. Each item is scored on a scale of 0-3; the total composite score range is 0-27; Lower score = better outcome.

  13. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Alcohol Use Disorders Identification Test (AUDIT-C): brief alcohol screen used to identify persons who have active alcohol use disorders, including alcohol abuse or dependence. Each item is scored on a scale of 0-4; the total composite score range is 0-68; For each item, a score of 4 or more in men and 3 or more in women is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders; Lower score = better outcome.

  14. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the SF-36 Health Measures: Multi-purpose, short-form health questionnaire of functional health and well-being scores. Over seven subsections, seven items are scored on a scale of 1-2 for a total composite score range of 7-14; ten items are scored on a scale of 1-3 for a total composite score range of 10-30; nine items are scored on a scale of 1-5 for a total composite score range of 9-45; and ten items are scored on a scale of 1-6 for a total composite score range of 10-60; Lower score = better outcome for 16 items; Higher score = better outcome for 20 items.

  15. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Mini International Neuropsychiatric Interview (MINI): Short diagnostic structured interview designed to assess various psychiatric disorders according to DSM-IV and ICD-10 criteria. 98 items on a Yes/No scale with a skip pattern (i.e. not all 98 questions will necessarily be answered) and 49 qualitative questions; Fewer reported symptoms = better outcome.

  16. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Berlin Questionnaire: self-reported questionnaire assessing snoring, sleepiness or fatigue, obesity and hypertension. Ten questions over three categories with non-uniform, symptom specific self-ratings; Positive (worse outcome) ranges are color-coded on the questionnaire.

  17. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Pittsburgh Sleep Quality Index (PSQI): self-rated questionnaire that assesses sleep quality, latency, duration, efficiency, disturbances, sleep medication, and daytime dysfunction over a one-month time interval. Six qualitative questions, 17 questions rating symptoms from "Not during the past month" to "Three or more times a week"; More answers of "Not during the past month" = better outcome.

  18. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Epworth Sleepiness Scale (ESS): self-report instrument on which respondents rate their chance of falling asleep in eight common daily situations. Each item is scored on a scale of 0-3; the total composite score range is 0-24; Lower score = better outcome.

  19. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Short Form McGill Pain Questionnaire (SF-MPQ): 15 descriptors (11 sensory, 4 affective) rated on intensity scale (1=mild, 2=moderate, 3=severe, 4=none) the total composite symptomatic score range is 15-45; Lower symptomatic score = better outcome; 60 (no symptoms on any of the items)=best outcome.

  20. Effects of a resilience building intervention on psychological, cardiovascular risk and resilience outcomes in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 3-6 months ]
    Changes in pre-to-post scores among intervention versus control group as measured by the Structured Trauma Interview (STI): A non-invasive test that gathers specific information about trauma-related cognitive and physiological symptoms. A clinician administers qualitative questions to participants hooked up to machines that record physiological reactions (e.g. heart rate); Lower physiological response=better outcome.


Secondary Outcome Measures :
  1. Effects of fear, cardiovascular physiology, and sleep patterns on response to a resilience building intervention in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 12 months ]
    Changes in pre-to-post measures among intervention versus control group as assessed by Actigraphy, a non-invasive approach to monitoring sleep/activity cycles that will collect five days of sleep data to assess sleep/wake behavior, circadian rhythm, and effectiveness of the intervention.

  2. Effects of fear, cardiovascular physiology, and sleep patterns on response to a resilience building intervention in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 12 months ]
    Changes in pre-to-post measures among intervention versus control group as assessed by Acoustic startle response (eyeblink component) that will be measured via electromyography (EMG) of the right orbicularis oculi muscle. The data will be sampled at 1 kHz, and the signal will be filtered using low and high frequency cutoffs of 28 and 500 Hz, respectively.

  3. Effects of fear, cardiovascular physiology, and sleep patterns on response to a resilience building intervention in a group of African American women with clinically significant posttraumatic stress symptoms [ Time Frame: 12 months ]
    Changes in pre-to-post measures among intervention versus control group as assessed by Skin Conductance Response to Trauma & Exposure that will analyze skin conductance levels at each assessment visit and change from maximum amplitude to the end of the session to capture degree of arousal in response to trauma.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • African American ( self-identified)
  • Diagnosis of PTSD
  • Between the ages of 18-64 other illnesses due to aging, cognitive declines due to aging, retirement change in life demands at age 65.
  • Able and willing to provide consent

Exclusion Criteria:

  • Active suicidality
  • Active alcohol and substance use of moderate or severe levels of severity
  • Psychosis
  • Current severe disabling illness( recent surgery, impending surgery, extreme pain interfering with participation)
  • Unable to meet attendance requirements:limit of 1 missed session of the 5.
  • Not engaged in other therapies for PTSD, cognitive behavior therapy, exposure therapy and reprocessing therapy.
  • Unable to participate in small group interactive setting.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890029


Contacts
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Contact: Priscilla Johnson, PhD, MSN 404-756-8827 pjohnson@msm.edu
Contact: Jane Mosley, MPH 404-752-1685 jmosley@msm.edu

Locations
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United States, Georgia
Grady Health Systems
Atlanta, Georgia, United States, 30303
Contact: Sharon Rachel, MA, MPH    404-756-5044    srachel@msm.edu   
Morehouse School of Medicine
Atlanta, Georgia, United States, 30310
Contact: Sharon Rachel, MA, MPH    404-756-5044    srachel@msm.edu   
Sponsors and Collaborators
Morehouse School of Medicine
Investigators
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Principal Investigator: Kisha B Holden, PhD, MSCR Morehouse School of Medicine
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Responsible Party: Kisha Holden, PhD, MSCR, Professor, Morehouse School of Medicine
ClinicalTrials.gov Identifier: NCT03890029    
Other Study ID Numbers: 1253996
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The research project will utilize the Morehouse School of Medicine Community Engagement Core for local, regional and national dissemination of findings. A community-based knowledge exchange event will be conducted in 3-5 years
Time Frame: 3-5 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kisha Holden, PhD, MSCR, Morehouse School of Medicine:
PTSD
Elevated Cardiovascular Disease risk
Resilience
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders