G.R.I.T. - Goal-directed Resilience Intervention Training

NCT03890029 | Completed

• 1 other identifier: 1253996
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Post-Traumatic Stress Disorder

Keywords

PTSD; Elevated Cardiovascular Disease risk; Resilience

Outcome Measures

Primary Outcomes (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

  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

  3-6 months

• 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

  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

  3-6 months

• 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

  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

  3-6 months

• 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

  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

  3-6 months

• 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

  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

  3-6 months

• 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

  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

  3-6 months

• 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

  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

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

• 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

  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.

  3-6 months

Secondary Outcomes (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

  12 months

Study Arms (2)

Intervention

OTHER

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

Control

OTHER

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

Interventions

Intervention Training BEHAVIORAL

After pre-testing and randomization, intervention participants will meet in small groups for 60 minutes/week over eight 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 eight weeks, all participants will be post-tested.

Intervention

Control Condition BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American/Black (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

You may not qualify if:

• 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 2 missed session of the 8.
• Not engaged in other therapies for PTSD, cognitive behavior therapy, exposure therapy and reprocessing therapy.
• Unable to participate in small group interactive setting.

Sponsors & Collaborators

• Morehouse School of Medicine: lead

Study Sites (2)

Grady Health Systems

Atlanta, Georgia, 30303, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kisha B Holden, PhD, MSCR

  Morehouse School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 26, 2019
• Study Start: July 13, 2021
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: 3-5 years

Locations

US (2)