Clinical trial NCT04257435: The Utility of Positive Psychology in Military TBI Rehabilitation
Official title: The Utility of Positive Psychology in Military TBI Rehabilitation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Fort Belvoir Community Hospital
Sponsor class: FED
Collaborators: name: The Defense and Veterans Brain Injury Center
First posted: 2020-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Positive Affect
timeFrame: Pre-treatment and at 3 month follow-up following study completion
Secondary outcomes:
measure: Change in Hope
timeFrame: Pre-treatment and at 3 month follow-up following study completion
measure: Change in Life Satisfaction
timeFrame: Pre-treatment and at 3 month follow-up following study completion
measure: Change in Depression
timeFrame: Pre-treatment and at 3 month follow-up following study completion
measure: Change in Perceived Stress
timeFrame: Pre-treatment and at 3 month follow-up following study completion
measure: Change in Cognitive Functioning
timeFrame: Pre-treatment and at 3 month follow-up following study completion
measure: Change in Fatigue
timeFrame: Pre-treatment and at 3 month follow-up following study completion
measure: Change in Pain Intensity
timeFrame: Pre-treatment and at 3 month follow-up following study completion
measure: Change in Negative Affect
timeFrame: Pre-treatment and at 3 month follow-up following study completion
Other outcomes:
Locations:
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
Study officials:
affiliation: Fort Belvoir Community Hospital
name: Deepa Elion, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Isen, AM, & Daubman, KA (1984). The influence of affect on categorization. Journal of Personality and Social Psychology, 47(6), 1206-1217.
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.
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.
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.
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.
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.
citation: Rashid, T (2015). Positive psychotherapy: A strength-based approach. The Journal of Positive Psychology, 10 (1), 25-40.