NCT04257435

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

March 18, 2019

Last Update Submit

February 3, 2020

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-treatment and at 3 month follow-up following study completion

Secondary Outcomes (8)

  • Change in Hope

    Pre-treatment and at 3 month follow-up following study completion

  • Change in Life Satisfaction

    Pre-treatment and at 3 month follow-up following study completion

  • Change in Depression

    Pre-treatment and at 3 month follow-up following study completion

  • Change in Perceived Stress

    Pre-treatment and at 3 month follow-up following study completion

  • Change in Cognitive Functioning

    Pre-treatment and at 3 month follow-up following study completion

  • +3 more secondary outcomes

Study Arms (2)

Traditional Behavioral Health Treatment

ACTIVE COMPARATOR
Behavioral: Traditional Behavioral Health Treatment

Positive Psychological Group Treatment

EXPERIMENTAL
Behavioral: Positive Psychological Group TreatmentBehavioral: Traditional Behavioral Health Treatment

Interventions

Positive Psychological Group TreatmentBEHAVIORAL

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).

Positive Psychological Group Treatment
Traditional Behavioral Health TreatmentBEHAVIORAL

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

Positive Psychological Group TreatmentTraditional Behavioral Health Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, 22060, United States

Location

Related Publications (10)

  • 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.

    PMID: 23390882BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 10467897BACKGROUND

  • Isen, AM, & Daubman, KA (1984). The influence of affect on categorization. Journal of Personality and Social Psychology, 47(6), 1206-1217.

    BACKGROUND

  • 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.

    PMID: 3598858BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 16351329BACKGROUND

  • 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.

    PMID: 16045394BACKGROUND

  • Seligman MEP, Rashid T, Parks AC. Positive psychotherapy. Am Psychol. 2006 Nov;61(8):774-788. doi: 10.1037/0003-066X.61.8.774.

    PMID: 17115810BACKGROUND

  • Rashid, T (2015). Positive psychotherapy: A strength-based approach. The Journal of Positive Psychology, 10 (1), 25-40.

    BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Deepa Elion, PhD

    Fort Belvoir Community Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

February 6, 2020

Study Start

September 1, 2019

Primary Completion

June 1, 2021

Study Completion

October 1, 2021

Last Updated

February 6, 2020

Record last verified: 2020-02

Locations

US(1)