NCT03282500

Brief Summary

The purpose of this research is to investigate the influence a mindfulness based cognitive therapy (MBCT) intervention will have on internalizing and externalizing problems in children and adolescents that have suffered a Traumatic Brain Injury (TBI). MBCT is a manualized intervention developed to increase social-emotional resiliency through mindful attention. Internalizing problems refer to a set of symptoms in which a person over-controls their emotions and results in social withdrawal, feelings of worthlessness, depression, and anxiety (Bloom et al., 2001). In contrast, externalizing problems refer to an under-control of emotions which results in conduct problems, impulsive behavior, and aggression. Social and emotional difficulties are prominent consequences of childhood TBI. Left untreated or undertreated, these problems often persist into adulthood, producing a wide range of challenges adapting in personal and vocational domains. At present, there are minimal non-pharmacological therapeutic approaches that effectively treat psychosocial deficits unique to TBI. Developing innovative, evidence based methods is essential in helping children recover from the injury.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

3 years

First QC Date

September 12, 2017

Last Update Submit

September 18, 2017

Conditions

Psychosocial Problems

Outcome Measures

Primary Outcomes (3)

  • Internalizing Symptoms

    We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in Internalizing symptoms (i.e., over-controlling emotions resulting in symptoms of depression and anxiety).

    8 weeks

  • Externalizing Symptoms

    We will examine the extent to which participants that have completed the experimental condition demonstrate a decrease in Externalizing symptoms (i.e., under-controlling emotions resulting in symptoms of impulsivity, hyperactivity, and aggression).

    8 weeks

  • Adaptive Functioning

    We will examine the extent to which participants that have completed the experimental condition demonstrate an increase in adaptive functioning (i.e., resilience, social skills, leadership, activities of daily living, and functional communication).

    8 weeks

Secondary Outcomes (1)

  • Attention

    8 weeks

Study Arms (2)

Mindfulness Based Cognitive Therapy

EXPERIMENTAL

In the experimental condition, participants will receive 12 sessions including the instruction of mindfulness skills and cognitive behavioral therapy.

Behavioral: Mindfulness Based Cognitive Therapy

Psychoeducation on brain injury and treatment

NO INTERVENTION

In the control condition, participants will receive 12 sessions on the psychoeducation of brain injuries, outcomes, treatment, and support.

Interventions

Mindfulness Based Cognitive TherapyBEHAVIORAL

The Mindfulness Based Cognitive Therapy (MBCT) intervention promotes self-regulation of emotions and behaviors within an accepting and non-judgmental therapeutic environment. During this interactive, multisensory program, participants will learn strategies to help manage their emotions and thoughts and help them to develop greater insight into the influence these experiences have on their behaviors. Participants will engage in brief at home exercises to enhance their learning of these new skills.

Mindfulness Based Cognitive Therapy

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Moderate or severe Traumatic Brain Injury (TBI)
  • TBI occurred at least 6 months prior
  • Age at enrollment: 9 to 17 years.
  • Elevated internalizing or externalizing symptoms

You may not qualify if:

  • Substantial impairment in language ability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

Related Publications (7)

  • Bloom DR, Levin HS, Ewing-Cobbs L, Saunders AE, Song J, Fletcher JM, Kowatch RA. Lifetime and novel psychiatric disorders after pediatric traumatic brain injury. J Am Acad Child Adolesc Psychiatry. 2001 May;40(5):572-9. doi: 10.1097/00004583-200105000-00017.

    PMID: 11349702BACKGROUND

  • Fann JR, Hart T, Schomer KG. Treatment for depression after traumatic brain injury: a systematic review. J Neurotrauma. 2009 Dec;26(12):2383-402. doi: 10.1089/neu.2009.1091.

    PMID: 19698070BACKGROUND

  • Cole WR, Gerring JP, Gray RM, Vasa RA, Salorio CF, Grados M, Christensen JR, Slomine BS. Prevalence of aggressive behaviour after severe paediatric traumatic brain injury. Brain Inj. 2008 Nov;22(12):932-9. doi: 10.1080/02699050802454808.

    PMID: 19005885BACKGROUND

  • Ganesalingam K, Yeates KO, Taylor HG, Walz NC, Stancin T, Wade S. Executive functions and social competence in young children 6 months following traumatic brain injury. Neuropsychology. 2011 Jul;25(4):466-76. doi: 10.1037/a0022768.

    PMID: 21463038BACKGROUND

  • Langlois J, Rutland-Brown W, Thomas K. Traumatic Brain Injury in the United States: Emergency Department Visits, Hospitalizations, and Deaths. Atlanta, GA: Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, 2006.

    BACKGROUND

  • Semrud-Clikeman M. Pediatric traumatic brain injury: rehabilitation and transition to home and school. Appl Neuropsychol. 2010 Apr;17(2):116-22. doi: 10.1080/09084281003708985.

    PMID: 20467952BACKGROUND

  • Iverson GL. Outcome from mild traumatic brain injury. Curr Opin Psychiatry. 2005 May;18(3):301-17. doi: 10.1097/01.yco.0000165601.29047.ae.

    PMID: 16639155BACKGROUND

MeSH Terms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Cherylynn Marino, Ph.D.

CONTACT

(973) 324-8431cmarino@kesslerfoundation.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The participants and outcomes assessor are blind to the assigned condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to either the experimental condition or the active control condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 14, 2017

Study Start

June 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

US(1)