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

NCT ID: NCT03890029

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-13
• Study Completion Date: 2023-03-07

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

Detailed Description

This project will utilize an intervention that is to encompass tenets of the New Wave therapies in two important respects:

1. The project's emphasis is on capacity development. The project's focus reaches beyond symptoms to restore and build resilience strengths that nurture in the face of challenge. The concept of resilience first entered the psychological and psychiatric literature with the study of children suffering from stress and disadvantage who, nevertheless, were functioning well. Protective factors included the presence of caring adults and achievement at school . Bonds and achievement have remained the most persistent findings in decades of research .

2. The investigator's aim is to restore and build capacities displaced by symptoms. This will be accomplished by identifying the lost capabilities in narratives of survival and identifying neuroscience models that capture symptoms and lost capacities as bio-behavioral response systems that become visible in extreme environments. Narratives of exceptional survival in extreme situations are characterized by engagement with their circumstances in ways that kept individuals well, by social relatedness, and by an efficient stress response . For example, while imprisoned in the Hanoi Hilton, Robert Shumaker built a dream house and counted the feet of lumber and number of nails that would needed. Fellow inmates also developed a tapping code to communicate with each other. Thus, Shumaker was engaged, was socially connected through tapping and, while engaged, was not hyper-responsive to the threat around him. The positive survival responses are a marked contrast to the symptoms of PTSD described earlier, such as hyperarousal or intrusive thoughts. What distinguishes resilient adaptation in extreme situations from PTSD is that the resilient activities are characterized by goal-directed actions while PTSD is characterized by stimulus-driven responses. The distinction of goal-directed versus stimulus-based responding is extensively developed in the neuroscience and cognitive literature. Action research has identified intention-based and stimulus-based actions in which self-initiated actions involve brain mechanisms and cognitive processes distinctly different from reflexive or responsive movement.

Broadly conceived, humans have two types of responses to the environment: they act to achieve results or goals in the environment, thus changing the environment, or they respond to and accommodate the demands of the environment and are changed by it. This distinction has its parallels in other areas of human functions. Attention studies have identified voluntary control of attention (endogenous) that is goal-directed versus automatic reflexive control (exogenous) in which external objects or events claim a subject's attention. A number of cortical models are relevant to goal-directed action and stimulus-based responding, among them the work on intention and reactivity by Astor-Jack and Haggard or the studies of Hannus and colleagues on stimulus-driven and user-driven control of visual attention.

Perhaps most relevant is the predictive and reactive control system (PARCS) developed by Tops and colleagues.

These two basic bio-behavioral programs control behavior in different environments, the reactive program being most adaptive in unpredictable environments and the predictive program most effective in highly predictable environments. The reactive program is guided by momentary feedback from the environment and responses are close in time and space. The predictive program guides behavior in a feed-forward manner that plans for the future, simulates alternatives, and makes predictions. In PTSD, stimulus-based responding prevails and displaces goal-directed responding at multiple levels of functioning: cortical, endocrine, affective, cognitive - indeed, the entire bio-behavioral system of predictive responding.

The abundant research on goal-directed action versus stimulus-based responding has few parallels in clinical psychology or psychiatry. Hints emerge in eudamonic well-being that is goal-directed and required for challenging situations and goal-relevant motivational constructs of self-efficacy or locus of control. This study draws on the extensive neuroscience framework to formulate a model of resilient and traumatic responses and proposes an approach that restores goal-directed responding that will simultaneously reduce the dominance of stimulus based symptoms of PTSD. This is a 5 year study with the anticipation of 148 enrolled.

Conditions

Chronic Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Intervention Training

Intervention Type: 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.

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

Group Type: OTHER

Control Condition

Intervention Type: 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.

Interventions

Intervention Training

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 Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Morehouse School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Kisha Holden, PhD, MSCR

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kisha B Holden, PhD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Morehouse School of Medicine

Locations

Grady Health Systems

Atlanta, Georgia, United States

Morehouse School of Medicine

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

1253996

Identifier Type: -

Identifier Source: org_study_id