CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 73 enrolled
Drug / intervention
Cognitive-Behavioral Therapy for Insomnia +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02658669
NCT02658669N/ACompleted

Cognitive Behavioral Therapy for Insomnia for Veterans With History of TBI

VA Office of Research and Development·interventional·Posted Jan 20, 2016·Updated Sep 25, 2024

In Brief

A clinical study evaluating Cognitive-Behavioral Therapy for Insomnia and Sleep Education for Insomnia and Traumatic Brain Injury. Completed, enrolled 73 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 20, 2016
Enrollment StartApr 1, 2016
Primary CompletionSep 30, 2022
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 10.5 years ago

Interventions

Cognitive-Behavioral Therapy for Insomniabehavioral

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

Sleep Educationbehavioral

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