Cognitive-Behavioral Therapy for Veterans With TBI

NCT02658669 | Completed Results

• 1 other identifier: D1512-W
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Many Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn era Veterans have suffered a mild traumatic brain injury (mTBI), and now cope with multiple post-injury symptoms, including sleep disturbances (especially insomnia). Chronic insomnia in mTBI patients has the potential to exacerbate other symptoms, delay recovery, and negatively affect many of the cognitive, psychological, and neuromuscular sequelae of mTBI, thereby decreasing quality of life. Although Cognitive-Behavioral Therapy for Insomnia (CBT-I) has been shown to be an effective evidence-based treatment for insomnia, there are no published randomized controlled trials evaluating the potential strengths and/or limitations of CBT-I in post-mTBI patients. Therefore, assessing CBT-I in the context of mTBI holds promise to provide substantial benefits in terms of improved rehabilitation outcomes in Veterans who have suffered mTBI.

Conditions

Insomnia; Traumatic Brain Injury

Keywords

Insomnia; Injury, Brain, Traumatic Mild

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity

  Change in insomnia severity. Scale used is Insomnia Severity Index (ISI). Minimum value= 0; maximum value = 28. Lower score equals better outcome.

  Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)

Secondary Outcomes (4)

• Change in Depressive Symptomatology

  Pre-Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)

• Change in PTSD Stressor Specific Checklist 5

  Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)

• Change in World Health Organization Disability Assessment Scale-2

  Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)

• Change in Pittsburgh Sleep Quality Index

  Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)

Other Outcomes (5)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pain

  Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)

• Change in Neuropsychological Functioning: Attention/Processing Speed

  Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)

• Change In Neuropsychological Functioning: Verbal Learning and Memory

  Pre- Treatment (0-weeks), Post-Treatment (8-weeks), Follow-Up (12-weeks)

Study Arms (2)

Cognitive-Behavioral Therapy for Insomnia

EXPERIMENTAL

6-week manualized treatment designed to improve symptoms of chronic insomnia.

Behavioral: Cognitive-Behavioral Therapy for Insomnia

Sleep Education

ACTIVE COMPARATOR

6-week manualized treatment designed to provide information regarding traumatic brain injury and its relationship to sleep disturbance, which incorporates training in sleep hygiene to help improve nighttime sleep and daytime functioning.

Behavioral: Sleep Education

Interventions

Cognitive-Behavioral Therapy for Insomnia BEHAVIORAL

Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training.

Also known as: CBT-I

Cognitive-Behavioral Therapy for Insomnia

Sleep Education BEHAVIORAL

Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep.

Sleep Education

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• OEF/OIF/OND Veteran ages 18-55.
• Documented history of mild TBI (documented in the medical record and where possible from the VA TBI second-level evaluation)
• Loss of consciousness 30 minutes
• Post-traumatic amnesia 1 day
• At least 3 months post-TBI.
• A diagnosis of insomnia classified as:
• Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria that include: trouble falling asleep, staying asleep, waking too early, and/or non-restorative sleep with accompanied daytime impairment in functioning for \> 3 months, occurring at least 3 nights per week.
• Subjective sleep disturbance defined by a Pittsburgh Sleep Quality Index score \>5 and Insomnia Severity Index score \>7 at intake.
• No prior exposure to and/or treatment with CBT-I within the past 2 years.
• Must be stable on medication regimen for at least 1 month prior to enrollment in study.

You may not qualify if:

• History of a neurological disorder (besides TBI), dementia, or premorbid IQ \<70.
• Schizophrenia, psychotic disorder, and/or bipolar disorder.
• Evidence of suicidality more than "low risk" as determined by the VA Comprehensive Suicide Risk Assessment (CSRA).
• Sleep disturbances other than insomnia (e.g., untreated obstructive sleep apnea and/or periodic limb movements)
• Alcohol and/or substance abuse within the past 30 days.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Related Links

• The SRS fosters scientific investigations on all aspects of sleep and its disorders.

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Brain Injuries, Traumatic; Brain Concussion

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Dr. Henry Orff
• Organization: VA San Diego Healthcare System

Henry.Orff@va.gov

(858) 642-6492

Study Officials

• Henry J. Orff, PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 20, 2016
• Study Start: April 1, 2016
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)