Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

NCT03261674 | Completed Results

• 1 other identifier: B2319-I
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).

Conditions

Insomnia; Traumatic Brain Injury

Keywords

Insomnia; Traumatic Brain Injury; Cognitive Behavioral Therapy; Veterans

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change. This 7-item instrument results in total scores ranging from 0 to 28, with higher scores indicating more severe symptoms. Scores above 15 indicate clinical insomnia, and scores above 22 indicate severe symptoms.

  Change from baseline at week 8 after treatment

Study Arms (2)

CBTI

EXPERIMENTAL

Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral: CBT-I

ABTI

EXPERIMENTAL

Arousal-Based Therapy for Insomnia (ABT-I)

Behavioral: ABT-I

Interventions

CBT-I BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I)

CBTI

ABT-I BEHAVIORAL

Arousal-Based Therapy for Insomnia (ABT-I)

ABTI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female Veterans of any racial or ethnic group
• Independent Living (not in nursing home or VA Extended Care facility)
• Diagnosis of insomnia using the Duke structured interview
• Male or female chronic (\>3 months since injury) mild Traumatic Brain Injury (mTBI).
• Subjects with PTSD will be included in this study as long as they do not meet criteria for depression described below.
• Use of CNS active medications that could significantly impact sleep or alertness is allowed as long as the dose, timing, and formulation are stable (≥ 3 weeks).
• Stable adult onset diabetes, controlled with insulin, oral medications or diet is acceptable.
• Use of medications, drugs, herbal remedies, or hormones specifically prescribed for treating sleep disturbances is allowed as long as the dose, timing, and formulation are stable (≥ 3 weeks).
• Subjects will be assessed for sleep apnea risk by the Berlin Questionnaire. Those with responses suggestive of high risk for apnea will be referred to Pulmonary Medicine for standard clinical screening, but will not be excluded. If subjects with obstructive sleep apnea are using CPAP, we will require stable use throughout the study.

You may not qualify if:

• Sleep-Related
• Excessive caffeine consumption (≥ 5 cups of coffee per day) and unable to reduce to ≤ 3 cups before lunch a day for ≥ 3 weeks prior to treatment.
• Subjects working a rotating shift or an unconventional daytime shift (ending after 1700 h, expected to be rare in the age group we are studying) will be ineligible.
• Neuropsychiatric
• Current or lifetime history of a psychiatric disorder with primary psychotic features.
• Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation.
• Current or within the past 30 days: drug abuse or dependence (except nicotine).
• Current or expected cognitive behavior therapy for another condition (e.g. depression).
• More than one glass of wine or beer with dinner scheduled at least 3 to 4 hours before bedtime. - Presence of any acute or unstable psychiatric condition(s) that requires referral for treatment.
• Folstein Mini-Mental State Exam (MMSE) \< 24.
• Medical
• \- Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (\> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if \< 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months. Unstable adult onset diabetes will be excluded.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Brain Injuries, Traumatic

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

Results Point of Contact

• Title: Dr Ansgar Furst; Rayma Williams
• Organization: VA Palo Alto

ansgar.furst@va.gov; rayma.williams@va.gov

(650) 339-4015

Study Officials

• Ansgar J. Furst, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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

Model Details: Parallel: participants are assigned to one of two or more groups in parallel for the duration of the study.

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 25, 2017
• Study Start: June 28, 2018
• Primary Completion: September 30, 2023
• Study Completion: April 25, 2024
• Last Updated: October 31, 2024
• Results First Posted: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)