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The Utility of Positive Psychology in Military TBI Rehabilitation

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04257435
Recruitment Status : Withdrawn (Unable to recruit individuals for the study)
First Posted : February 6, 2020
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
The Defense and Veterans Brain Injury Center
Information provided by (Responsible Party):
Fort Belvoir Community Hospital

Brief Summary:

Service members and veterans (SMVs) report more persisting symptoms following traumatic brain injury (TBI) compared to civilian populations (Ommaya, Ommaya, Dannenber, & Salazar, 1996). Therefore, it is important to utilize interventions that reduce psychological impairments and increase resiliency during military TBI rehabilitation. Unlike traditional behavioral health treatments that focus on reducing maladaptive behaviors and negative thoughts, positive psychological treatments focus on increasing positive emotions to increase well-being. There is substantial growing evidence demonstrating that cultivating positive emotions is preventative and improves resiliency and psychological (Bolier et al., 2013; Sin & Lyumbomirsky, 2009), cognitive (Estrada, Isen, & Young, 1997; Ashby & Isen, 1999; Isen & Daubman, 1984; Isen, Daubman, & Nowicki, 1987; Fredrickson & Branigan, 2001), and health outcomes (Pressman & Cohen, 2005). This study will examine the effectiveness of traditional behavioral health treatment versus behavioral health treatment with an added positive psychological group treatment in terms of psychological, cognitive, and health outcomes during TBI rehabilitation. The hypothesis is that SMV's with TBI will experience improved outcomes with added positive psychological treatment compared to traditional behavioral health treatment alone.

There will be about 100 people taking part in the study, randomly assigned to either a traditional behavioral health treatment group or an alternative behavioral health treatment group (therefore, up to 50 people will be enrolled in each) at the Fort Belvoir Intrepid Spirit Center over a period of 30 months. Study participants will be randomly assigned to groups, and over 3 months the study procedures include participating in group behavioral health treatment and/or individual behavioral health treatment and completing pre/post-treatment questionnaires focusing on psychological, cognitive, and health outcomes. The behavioral health intervention has not been well-studied; thus, the behavioral health intervention is considered experimental for the treatment of psychological symptoms. Additionally, the impact on other areas of functioning (i.e., cognitive functioning and overall health) is currently unknown.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Behavioral: Positive Psychological Group Treatment Behavioral: Traditional Behavioral Health Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Utility of Positive Psychology in Military TBI Rehabilitation
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Traditional Behavioral Health Treatment Behavioral: Traditional Behavioral Health Treatment
Treatment will include traditional individual behavioral health treatment, involving CBT-based therapeutic interventions for presenting diagnoses (typically depression, anxiety, or PTSD-related symptomatology).

Experimental: Positive Psychological Group Treatment Behavioral: Positive Psychological Group Treatment
Positive psychological group treatment will involve engagement in traditional behavioral health treatment, as well as a group treatment focusing on previously researched exercises that have been demonstrated to relate to reduced depression and increased positive emotionality (Seligman, Rashid, Parks, et al., 2005; Seligman, Rashid, & Parks, 2006; Rashid, 2015).

Behavioral: Traditional Behavioral Health Treatment
Treatment will include traditional individual behavioral health treatment, involving CBT-based therapeutic interventions for presenting diagnoses (typically depression, anxiety, or PTSD-related symptomatology).




Primary Outcome Measures :
  1. Change in Positive Affect [ Time Frame: Pre-treatment and at 3 month follow-up following study completion ]
    The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire on which participants rate adjectives of positive and negative feelings on a scale from 1 (very slightly/not at all) to 5 (extremely) according to how much they are currently experiencing that feeling. The sum of the positive items provides a measure of positive affect at each time point.


Secondary Outcome Measures :
  1. Change in Hope [ Time Frame: Pre-treatment and at 3 month follow-up following study completion ]
    The Hope Scale is a 12-item self-report questionnaire examining a patient's willful sense of determination to meet goals and a patient's perceived availability of ways to attain a goal. Higher ratings indicate greater hope at time of measurement.

  2. Change in Life Satisfaction [ Time Frame: Pre-treatment and at 3 month follow-up following study completion ]
    The General Life Satisfaction scale from NIH Toolbox is a 5-item scale designed to measure global cognitive judgments of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. The total summed score will indicate satisfaction with life.

  3. Change in Depression [ Time Frame: Pre-treatment and at 3 month follow-up following study completion ]
    The Patient Health Questionnaire-9 is a 9-item measure given to screen for the presence and severity of depression. The total summed score indicates level of depression.

  4. Change in Perceived Stress [ Time Frame: Pre-treatment and at 3 month follow-up following study completion ]
    The Perceived Stress scale from NIH Toolbox is a 10-item measure given to assess perceptions about the nature of events and their relationship to the values and coping resources of an individual. Participants indicate how often behaviors and/or thoughts related to stress have occurred on a 5-point scale (Never to Very Often). The total summed score indicates overall perceived stress.

  5. Change in Cognitive Functioning [ Time Frame: Pre-treatment and at 3 month follow-up following study completion ]
    The Cognitive Functioning scale from Neuro QOL includes 8 items measuring perceived difficulties in cognitive abilities (e.g., memory, attention, and decision making, or in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering and learning). Items are answered as 1=Not at all, 2=A little bit, 3=Somewhat, 4=Quite a bit, 5=Very much. The total summed score indicates perceived cognitive functioning.

  6. Change in Fatigue [ Time Frame: Pre-treatment and at 3 month follow-up following study completion ]
    The Fatigue scale from Neuro QOL includes 8 items measuring sensations of tiredness to exhaustion that decreases one's capacity for physical, functional, social, and mental activities. Items are rated on a 5-point scale ranging from never to always. The total summed score indicates level of fatigue.

  7. Change in Pain Intensity [ Time Frame: Pre-treatment and at 3 month follow-up following study completion ]
    The Pain Intensity Survey from NIH Toolbox includes one item for self-reporting a participant's level of pain in the past seven days, ranging from 0 (no pain) to 10 (worst imaginable pain).

  8. Change in Negative Affect [ Time Frame: Pre-treatment and at 3 month follow-up following study completion ]
    The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire on which participants rate adjectives of positive and negative feelings on a scale from 1 (very slightly/not at all) to 5 (extremely) according to how much they are currently experiencing that feeling. The sum of the negative items provides a measure of negative affect at each time point.



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented mild TBI or moderate TBI.
  • Individual is recommended to have a Behavioral Health provider at ISC Fort Belvoir for general TBI-related psychological impairments.
  • Individual has decision making capacity for informed consent based on medical provider clinical judgement and initial evaluation.
  • Individual scored a 14 or lower on the Patient Health Questionnaire-9, indicating no worse than moderate depressive symptoms.
  • Individual is 18 years or older.
  • Individual is Defense Enrollment Eligibility Reporting System-eligible.

Exclusion Criteria:

  • Individuals with severe depressive symptoms (PHQ-9 score above 14).
  • Documented severe traumatic brain injury.
  • Minors and pediatric populations.

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): NCT04257435


Locations
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United States, Virginia
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060
Sponsors and Collaborators
Fort Belvoir Community Hospital
The Defense and Veterans Brain Injury Center
Investigators
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Principal Investigator: Deepa Elion, PhD Fort Belvoir Community Hospital
Publications:
Estrada C, Isen AM, & Young MJ (1997). Positive affect facilitates integration of information and decreases anchoring in reasoning among physicians. Organizational Behavior and Human Decision Processes, 72, 117-135.
Isen, AM, & Daubman, KA (1984). The influence of affect on categorization. Journal of Personality and Social Psychology, 47(6), 1206-1217.
Fredrickson, BL, Branigan, A (2001). Positive emotions. In: Mayne, T.J.; Bonnano, G.A., editors. Emotion: Current issues and future developments. New York: Guilford Press, 123-151.
Rashid, T (2015). Positive psychotherapy: A strength-based approach. The Journal of Positive Psychology, 10 (1), 25-40.

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Responsible Party: Fort Belvoir Community Hospital
ClinicalTrials.gov Identifier: NCT04257435    
Other Study ID Numbers: The UPP Study
WRNMMC-2019-0216 ( Other Identifier: WRNMMC )
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries