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The Utility of Positive Psychology in Military TBI Rehabilitation

Primary Purpose

Traumatic Brain Injury

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Psychological Group Treatment
Traditional Behavioral Health Treatment
Sponsored by
Fort Belvoir Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fort Belvoir Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Behavioral Health Treatment

Positive Psychological Group Treatment

Arm Description

Outcomes

Primary Outcome Measures

Change in Positive Affect
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

Change in Hope
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.
Change in Life Satisfaction
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.
Change in Depression
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.
Change in Perceived Stress
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.
Change in Cognitive Functioning
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.
Change in Fatigue
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.
Change in Pain Intensity
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).
Change in Negative Affect
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.

Full Information

First Posted
March 18, 2019
Last Updated
February 3, 2020
Sponsor
Fort Belvoir Community Hospital
Collaborators
The Defense and Veterans Brain Injury Center
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1. Study Identification

Unique Protocol Identification Number
NCT04257435
Brief Title
The Utility of Positive Psychology in Military TBI Rehabilitation
Official Title
The Utility of Positive Psychology in Military TBI Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit individuals for the study
Study Start Date
September 2019 (Anticipated)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fort Belvoir Community Hospital
Collaborators
The Defense and Veterans Brain Injury Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Behavioral Health Treatment
Arm Type
Active Comparator
Arm Title
Positive Psychological Group Treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Positive Psychological Group Treatment
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Traditional Behavioral Health Treatment
Intervention Description
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 Measure Information:
Title
Change in Positive Affect
Description
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.
Time Frame
Pre-treatment and at 3 month follow-up following study completion
Secondary Outcome Measure Information:
Title
Change in Hope
Description
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.
Time Frame
Pre-treatment and at 3 month follow-up following study completion
Title
Change in Life Satisfaction
Description
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.
Time Frame
Pre-treatment and at 3 month follow-up following study completion
Title
Change in Depression
Description
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.
Time Frame
Pre-treatment and at 3 month follow-up following study completion
Title
Change in Perceived Stress
Description
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.
Time Frame
Pre-treatment and at 3 month follow-up following study completion
Title
Change in Cognitive Functioning
Description
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.
Time Frame
Pre-treatment and at 3 month follow-up following study completion
Title
Change in Fatigue
Description
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.
Time Frame
Pre-treatment and at 3 month follow-up following study completion
Title
Change in Pain Intensity
Description
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).
Time Frame
Pre-treatment and at 3 month follow-up following study completion
Title
Change in Negative Affect
Description
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.
Time Frame
Pre-treatment and at 3 month follow-up following study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepa Elion, PhD
Organizational Affiliation
Fort Belvoir Community Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fort Belvoir Community Hospital
City
Fort Belvoir
State/Province
Virginia
ZIP/Postal Code
22060
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23390882
Citation
Bolier L, Haverman M, Westerhof GJ, Riper H, Smit F, Bohlmeijer E. Positive psychology interventions: a meta-analysis of randomized controlled studies. BMC Public Health. 2013 Feb 8;13:119. doi: 10.1186/1471-2458-13-119.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
10467897
Citation
Ashby FG, Isen AM, Turken AU. A neuropsychological theory of positive affect and its influence on cognition. Psychol Rev. 1999 Jul;106(3):529-50. doi: 10.1037/0033-295x.106.3.529.
Results Reference
background
Citation
Isen, AM, & Daubman, KA (1984). The influence of affect on categorization. Journal of Personality and Social Psychology, 47(6), 1206-1217.
Results Reference
background
PubMed Identifier
3598858
Citation
Isen AM, Daubman KA, Nowicki GP. Positive affect facilitates creative problem solving. J Pers Soc Psychol. 1987 Jun;52(6):1122-31. doi: 10.1037//0022-3514.52.6.1122.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
16351329
Citation
Pressman SD, Cohen S. Does positive affect influence health? Psychol Bull. 2005 Nov;131(6):925-971. doi: 10.1037/0033-2909.131.6.925.
Results Reference
background
PubMed Identifier
16045394
Citation
Seligman ME, Steen TA, Park N, Peterson C. Positive psychology progress: empirical validation of interventions. Am Psychol. 2005 Jul-Aug;60(5):410-21. doi: 10.1037/0003-066X.60.5.410.
Results Reference
background
PubMed Identifier
17115810
Citation
Seligman MEP, Rashid T, Parks AC. Positive psychotherapy. Am Psychol. 2006 Nov;61(8):774-788. doi: 10.1037/0003-066X.61.8.774.
Results Reference
background
Citation
Rashid, T (2015). Positive psychotherapy: A strength-based approach. The Journal of Positive Psychology, 10 (1), 25-40.
Results Reference
background

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The Utility of Positive Psychology in Military TBI Rehabilitation

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