Health TrialsbyHealthPanel

Improving Cognitive Rehabilitation Outcomes

ConditionsMild Traumatic Brain InjuryPosttraumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

Posttraumatic stress disorder (PTSD) and mild TBI (mTBI) frequently co-occur in post-9/11 Veterans, and together are associated with worse cognitive performance, mental health, everyday functioning, community integration, quality of life, and treatment response than either condition alone. Additional comorbidities, such as depression and sleep disturbance, are common and further exacerbate these problems. The investigators will investigate Compensatory Cognitive Training (CCT) and Morning Bright Light Therapy (MBLT) vs Negative Ion Generator (ION), to directly target cognition, depression, and sleep disturbance and to improve CCT-associated rehabilitation outcomes. The investigator's randomized controlled trial in 144 Veterans with mTBI+PTSD across two VA sites will compare cognition, functioning, and other secondary outcomes following CCT+MBLT vs. CCT+ION. This study addresses the significant gap in services and evidence-based treatments for Veterans with mTBI+PTSD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Post 9/11 Veterans enrolled at VA San Diego or VA Portland

Ability to provide informed consent

Living independently

History of mTBI confirmed by OSU-TBI

Disqualifiers

Current substance use disorder with <30 days abstinence

History of primary psychotic disorder

History of moderate to severe TBI (loss of consciousness >30 minutes)

History of macular degeneration or bipolar disorder (both contraindicated for bright light therapy)

Trial design

Design model

Parallel

Treatments tested in this trial

  • CCT+MBLT

    Device

    Compensatory Cognitive Training + Morning Bright Light Therapy (Aurora LightPad)

  • CCT+ION

    Device

    Compensatory Cognitive Training + Negative Ion Generator (SphereOne)

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: CCT+MBLTExperimental treatment 1 intervention
Group B: CCT+IONSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective Cognitive Performance

Composite z score of Hopkins Verbal Learning Test-Revised; Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV) Digit Span; WAIS-IV Coding; Delis-Kaplan Executive Function System (D-KEFS) Trails; D-KEFS Color-Word Interference; and the UCSD Performance-Based Skills Assessment-Brief (UPSA-B). There is no minimum or maximum value of a z score. Higher scores will reflect better outcomes.

Time frame
baseline, 10 weeks
2

Functioning

Composite z score of Brief Inventory of Psychosocial Functioning and the World Health Organization Disability Assessment Schedule 2.0. There is no minimum or maximum value of a z score. Higher scores will reflect better outcomes.

Time frame
baseline, 10 weeks

Secondary outcomes

1

Insomnia Severity Index

Insomnia severity. Scores range from 0-28, with higher scores representing worse insomnia.

Time frame
baseline, 10 weeks
2

Pittsburgh Sleep Quality Index

Sleep quality. Scores range from 0-21, with higher scores representing worse sleep quality.

Time frame
baseline, 10 weeks
3

Total Sleep Time

Total Sleep Time derived from Actiwatch2. Minutes range from 0 to 1440 per day, with higher numbers reflecting more minutes of sleep.

Time frame
baseline, 10 weeks
4

Patient Health Questionnaire-9

Depression symptom severity. Scores range from 0-27, with higher scores reflecting worse depression symptoms.

Time frame
baseline, 10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Portland VA Medical Center

Collaborator

Source ClinicalTrials.gov
Apply now