NCT01040858

Brief Summary

The number of OEF/OIF veterans seeking care and rehabilitation services within the VA Health Care System is increasing rapidly. The cognitive effects of MTBI are clinically significant and can adversely affect a veteran's ability to reintegrate into civilian life, return to duty, succeed in competitive employment, or function independently. The primary product of the proposed study would be an empirically validated, manualized, cognitive rehabilitation intervention for OIF/OIF veterans with cognitive disorders. The group treatment modality has the virtue of efficiency and a manualized treatment approach would allow wide-ranging application throughout the VHA system. As such, the proposed study is likely to have a significant effect on the quality and effectiveness of rehabilitative services being offered to our returning soldiers with combat-related MTBI and cognitive impairment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

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

December 28, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

January 26, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

2 years

First QC Date

December 28, 2009

Results QC Date

November 7, 2014

Last Update Submit

January 14, 2015

Conditions

Cognition Disorders

Keywords

cognitive strategy interventioncognitive disorders

Outcome Measures

Primary Outcomes (1)

  • Multiple Sclerosis Neuropsychological Screening Questionnaire-Patient Version

    A self-report measure of severity of attention and organizational problems. It measures the sum of severity ratings on a scale from 0 (never) to 4 (very often). The total score ranges from 0 to 64.

    Week 10

Secondary Outcomes (11)

  • Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford, Henry, Ward, &

    Week 10

  • The Neurobehavioral Symptom Inventory

    Week 10

  • Memory Compensation Questionnaire

    Week 10

  • Hopkins Verbal Memory Test-Revised

    Week 10

  • Wechsler Adult Intelligence Scale-3rd Edition, Digit Span Subtest

    Week 10

  • +6 more secondary outcomes

Study Arms (2)

Cognitive Strategies Training

EXPERIMENTAL

Participants in the experimental group will receive the Cognitive strategy intervention during the first ten weeks of their participation in the study, whereas comparison group participants will continue to receive usual care (no cognitive strategy intervention) during their participation in the study (but will be offered cognitive strategy intervention after the end of the study). Cognitive Strategies training consisted of interactive didactic presentations, in-class discussions, and activities that introduced participants to a variety of cognitive strategies and external aids.

Behavioral: Cognitive Strategy Training

Placebo comparison group

PLACEBO COMPARATOR

Participants in the experimental group will receive the Cognitive strategy intervention during the first ten weeks of their participation in the study, whereas comparison group participants will continue to receive usual care (no cognitive strategy intervention) during their participation in the study (but will be offered cognitive strategy intervention after the end of the study).

Other: Placebo comparison group

Interventions

Cognitive Strategy TrainingBEHAVIORAL

Cognitive Strategy Training will consist of weekly 120-minute group sessions for 10 weeks.

Cognitive Strategies Training
Placebo comparison groupOTHER

Participants in the experimental group will receive the Cognitive strategy intervention during the first ten weeks of their participation in the study, whereas comparison group participants will continue to receive usual care (no cognitive strategy intervention) during their participation in the study (but will be offered cognitive strategy intervention after the end of the study).

Placebo comparison group

Eligibility Criteria

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

You may qualify if:

  • OEF/OIF veterans enrolled at a participating VA who are able to provide informed consent; and
  • As part of standard VA clinical care, have screened positive for MTBI and complain of cognitive impairment.

You may not qualify if:

  • Current substance use disorder with less than 30 days abstinence;
  • History of a primary psychotic disorder; and
  • Auditory or visual impairments that would prevent ability to participate in the cognitive rehabilitation group or benefit from compensatory strategies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

VA Medical Center, Boise

Boise, Idaho, 83702, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (1)

  • Pagulayan KF, O'Neil M, Williams RM, Turner AP, Golshan S, Roost MS, Laman-Maharg B, Huckans M, Storzbach D, Twamley EW. Mental Health Does Not Moderate Compensatory Cognitive Training Efficacy for Veterans With a History of Mild Traumatic Brain Injury. Arch Phys Med Rehabil. 2017 Sep;98(9):1893-1896.e2. doi: 10.1016/j.apmr.2017.04.009. Epub 2017 May 5.

    PMID: 28483653DERIVED

MeSH Terms

Conditions

Cognition DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Daniel Storzbach
Organization
Portland VA Healthcare System
Daniel.Storzbach@va.gov
503-220-8262

Study Officials

  • Daniel M Storzbach, PhD

    VA Medical Center, Portland

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2009

First Posted

December 30, 2009

Study Start

May 1, 2011

Primary Completion

May 1, 2013

Study Completion

September 1, 2013

Last Updated

January 26, 2015

Results First Posted

January 26, 2015

Record last verified: 2015-01

Locations

US(4)