NCT01339806

Brief Summary

The objective of this trial is to evaluate the effectiveness of cognitive rehabilitation in OIF/OEF service members with a history of mild traumatic brain injury and persistent (3-24 months post injury) cognitive complaints. This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study. Subjects will be evaluated prior to the start of treatment and 3, 6, 12, and 18 weeks following the initiation of the study. The total number of patients to be studied is 160 (maximum), which is approximately 20 patients per month.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

April 15, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 9, 2015

Status Verified

February 1, 2015

Enrollment Period

3 years

First QC Date

April 15, 2011

Last Update Submit

February 6, 2015

Conditions

Traumatic Brain Injury With Brief Loss of ConsciousnessTraumatic Brain Injury With No Loss of Consciousness

Keywords

mTBIConcussion

Outcome Measures

Primary Outcomes (15)

  • Emotional Functioning

    Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index and 9 subscales: Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism

    Baseline

  • Cognitive Efficiency

    Paced Auditory Serial Addition Test (PASAT) * correct trial 1 * correct trial 2 * correct trial 3 * correct trial 4 Sum of trials 1-4

    Baseline

  • Functional Behaviors

    Key Behaviors Change Inventory (KBCI) Total score Inattention- raw \& T-score Impulsivity- raw \& T-score Unawareness of Problems - raw \& T-score Apathy - raw \& T-score Interpersonal Difficulties - raw \& T-score Communication Problems - raw \& T-score Somatic Difficulties - raw \& T-score Emotional Adjustment - raw \& T-score 64 individual items

    Baseline

  • Emotional Functioning

    Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index and 9 subscales: Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism

    3 Weeks

  • Emotional Functioning

    Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index and 9 subscales: Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism

    6 Weeks

  • Emotional Functioning

    Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index and 9 subscales: Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism

    12 Weeks

  • Emotional Functioning

    Symptom Checklist-90-Revised (SCL-90-R) Global Severity Index and 9 subscales: Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism

    18 Weeks

  • Cognitive Efficiency

    Paced Auditory Serial Addition Test (PASAT) * correct trial 1 * correct trial 2 * correct trial 3 * correct trial 4 Sum of trials 1-4

    3 Weeks

  • Cognitive Efficiency

    Paced Auditory Serial Addition Test (PASAT) * correct trial 1 * correct trial 2 * correct trial 3 * correct trial 4 Sum of trials 1-4

    6 Weeks

  • Cognitive Efficiency

    Paced Auditory Serial Addition Test (PASAT) * correct trial 1 * correct trial 2 * correct trial 3 * correct trial 4 Sum of trials 1-4

    12 Weeks

  • Cognitive Efficiency

    Paced Auditory Serial Addition Test (PASAT) * correct trial 1 * correct trial 2 * correct trial 3 * correct trial 4 Sum of trials 1-4

    18 Weeks

  • Functional Behaviors

    Key Behaviors Change Inventory (KBCI) Total score Inattention- raw \& T-score Impulsivity- raw \& T-score Unawareness of Problems - raw \& T-score Apathy - raw \& T-score Interpersonal Difficulties - raw \& T-score Communication Problems - raw \& T-score Somatic Difficulties - raw \& T-score Emotional Adjustment - raw \& T-score 64 individual items

    3 Weeks

  • Functional Behaviors

    Key Behaviors Change Inventory (KBCI) Total score Inattention- raw \& T-score Impulsivity- raw \& T-score Unawareness of Problems - raw \& T-score Apathy - raw \& T-score Interpersonal Difficulties - raw \& T-score Communication Problems - raw \& T-score Somatic Difficulties - raw \& T-score Emotional Adjustment - raw \& T-score 64 individual items

    6 Weeks

  • Functional Behaviors

    Key Behaviors Change Inventory (KBCI) Total score Inattention- raw \& T-score Impulsivity- raw \& T-score Unawareness of Problems - raw \& T-score Apathy - raw \& T-score Interpersonal Difficulties - raw \& T-score Communication Problems - raw \& T-score Somatic Difficulties - raw \& T-score Emotional Adjustment - raw \& T-score 64 individual items

    12 Weeks

  • Functional Behaviors

    Key Behaviors Change Inventory (KBCI) Total score Inattention- raw \& T-score Impulsivity- raw \& T-score Unawareness of Problems - raw \& T-score Apathy - raw \& T-score Interpersonal Difficulties - raw \& T-score Communication Problems - raw \& T-score Somatic Difficulties - raw \& T-score Emotional Adjustment - raw \& T-score 64 individual items

    18 Weeks

Secondary Outcomes (47)

  • Fatigue

    Baseline

  • Post-Concussive Symptoms

    Baseline

  • Self Reported Quality of Life

    Baseline

  • Neuropsychological Status

    Baseline

  • Self Reported Alcohol Use Behaviors

    Baseline

  • +42 more secondary outcomes

Study Arms (4)

Standard of Care for mTBI Provider Arm

OTHER

Arm 1: Psychoeducational Control Group. Individuals assigned to arm 1 will receive psychoeducational materials specifically adapted for persistent management of symptoms and routine follow-up with medical providers (every three weeks). Additionally, subjects assigned to this group will receive medical care (e.g., psychopharmacological management of depression) and/or referral for symptom management (e.g., vestibular rehabilitation) of non-cognitive complaints, consistent with the current standard of care treatment model for managing post-concussive symptoms (see Figure below adapted with permission from authors; Brenner et al., 2009).

Behavioral: Informational Handout/Provider Visits

Computer Based Therapy Group

EXPERIMENTAL

Arm 2: Non-therapist directed computerized cognitive rehabilitation. Individuals assigned to treatment arm 2 will receive ten hours of in-clinic, computerized treatment per week throughout the 6-week treatment trial. Participants will be scheduled for 2 hours per day, proctored by clinic staff (certified recreation therapist or neuropsychology technician) who will be responsible for recording daily performance, providing positive reinforcement of participation, and effort. Computer programs selected for this treatment trial include both skill-specific training (e.g., attention processes) and general cognitive activation. These computer programs are commercially available and advertised as "brain fitness" or "brain training."

Behavioral: BrainworksBehavioral: Informational Handout/Provider Visits

Cognitive Rehab Group

EXPERIMENTAL

Arm 3: Therapist-directed individualized cognitive rehabilitation. Individuals assigned to treatment arm 3 will receive 10 hours of individual and group cognitive rehabilitation treatment (including homework assignments) per week conducted by credentialed speech therapists and occupational therapists. The treatment components will include five hours of weekly individual therapy (one-hour sessions; two hours focused on compensatory strategies and three hours focused on restorative strategies), two hours of weekly group therapy (one hour sessions focused on compensatory strategies), and three hours of weekly computer-based "homework" proctored by clinic staff who will be responsible for recording performance, and providing positive reinforcement of participation and effort.

Behavioral: Cognitive RehabBehavioral: Informational Handout/Provider Visits

Cognitive and Psychological Based Rehab

EXPERIMENTAL

Arm 4: Integrated interdisciplinary cognitive rehabilitation combined with cognitive-behavioral psychotherapy. Individuals assigned to treatment arm 4 will receive 10 hours of individual and group treatment per week conducted by credentialed therapists and doctoral-level psychologists. The treatment components will include four hours of weekly 1 hr individual therapy sessions; 2 hrs of cognitive rehabilitation, 1 hr of cognitive rehab \& 1 hr of individual psychotherapy targeting anxiety/combat stress symptoms including relaxation training \& exposure therapy and cognitive-behavioral principles, 3 hrs of weekly group therapy \& three hours of weekly "homework" including 30-mins relaxation training, 30-mins cognitive-behavioral psychotherapy homework, and 2 hrs of computerized cognitive rehabilitation exercises proctored by clinic staff.

Behavioral: Cognitive RehabBehavioral: Informational Handout/Provider Visits

Interventions

Cognitive RehabBEHAVIORAL

APT-III, Other standard individual and group interventions.

Also known as: APT-III
Cognitive Rehab GroupCognitive and Psychological Based Rehab
BrainworksBEHAVIORAL

POSIT

Also known as: POSIT
Computer Based Therapy Group
Informational Handout/Provider VisitsBEHAVIORAL

Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.

Cognitive Rehab GroupCognitive and Psychological Based RehabComputer Based Therapy GroupStandard of Care for mTBI Provider Arm

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of mTBI as defined in the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009) which occurred during deployment in support of OEF/OIF within 3-24 months of study enrollment;
  • Presence of cognitive complaints (NSI score of 3 or higher on any of the four cognitive symptoms)
  • Ability to understand and communicate in English.

You may not qualify if:

  • Medical/psychiatric/neurologic co-morbidities of: blindness/low vision; uncontrolled seizure disorder; psychosis; history of moderate, severe TBI or penetrating BI; or Spinal Cord Injury with no use of upper extremities;
  • Active participation in intensive (\> 5 appointments per week) treatment for amputation, orthopedic trauma, burns, substance abuse, or post-traumatic stress disorder which would preclude full participation in an intensive cognitive rehabilitation program; or
  • Daily use of narcotic pain medication(s).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (2)

  • Vanderploeg RD, Cooper DB, Curtiss G, Kennedy JE, Tate DF, Bowles AO. Predicting treatment response to cognitive rehabilitation in military service members with mild traumatic brain injury. Rehabil Psychol. 2018 May;63(2):194-204. doi: 10.1037/rep0000215.

    PMID: 29878826DERIVED

  • Cooper DB, Bowles AO, Kennedy JE, Curtiss G, French LM, Tate DF, Vanderploeg RD. Cognitive Rehabilitation for Military Service Members With Mild Traumatic Brain Injury: A Randomized Clinical Trial. J Head Trauma Rehabil. 2017 May/Jun;32(3):E1-E15. doi: 10.1097/HTR.0000000000000254.

    PMID: 27603763DERIVED

Related Links

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Amy O Bowles, MD

    BAMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
TBI Service Chief

Study Record Dates

First Submitted

April 15, 2011

First Posted

April 21, 2011

Study Start

June 1, 2011

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

February 9, 2015

Record last verified: 2015-02

Locations

US(1)