Behavioral Insomnia Treatment in Mild Traumatic Brain Injury

Официальное название

Cognitive Behavioral Therapy for Insomnia vs Brief Behavioral Therapy for Insomnia in Military Personnel With Postconcussive Symptoms Following Mild Traumatic Brain Injury

Обзор

This is a single site, two-armed random controlled trials (RCT) comparing six sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) with four sessions of Brief Behavioral Therapy for Insomnia (BBT-I) in service members with comorbid insomnia and prolonged postconcussive symptoms present for at least 3 months after Mild Traumatic Brain Injury (mTBI).

Подробное описание

The purpose of this study is to identify the optimal behavioral treatment for insomnia in service members with comorbid insomnia and prolonged postconcussive symptoms following Mild Traumatic Brain Injury (mTBI). The study will compare Cognitive Behavioral Therapy for Insomnia (CBT-I) and Brief Behavioral Therapy for Insomnia (BBT-I) and determine the impact of behavioral insomnia treatment on insomnia symptom severity. This study will explore the impact of insomnia treatment on prolonged postconcussive symptoms and blood-based biomarkers. The overall objective is to determine if behavioral insomnia therapy can improve outcomes in service members with prolonged postconcussive symptoms following mTBI.

Both in-person and telehealth treatment formats will be offered to adapt to the service members schedule. The minimum acceptable number of sessions to the interventions in order to have evaluable data will be 4 sessions for CBT-I and 3 sessions for BBT-I. A participant is considered to have completed the study if he or she has completed the baseline assessment, at least 4 sessions for CBT-I and 3 sessions for BBT-I, and the 7-week and 12-week follow-up assessments.

Participants will be seen and treated at the Intrepid Spirit Center and/or the STRONG STAR offices both part of the Carl R. Darnall Army Medical Center (CRDAMC) located on the Fort Cavazos. Active duty service members at least 18 years of age who are seeking clinical care for persisting mTBI symptoms at the Intrepid Spirit Center located on Fort Cavazos. Women will be actively recruited into the study.

Вмешательства

• Поведенческое Cognitive Behavioral Therapy for Insomnia
  6 weekly, 50-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.
• Поведенческое Brief Behavioral Therapy for Insomnia
  4 weekly, 30-minute sessions delivered individually using in-person or telehealth format by a trained behavioral health provider.

Первичные конечные точки

• Insomnia Severity Index (ISI) [Срок оценки: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up]
• Neurobehavioral Symptom Inventory (NSI) [Срок оценки: Baseline, 7 Week Follow-up, 12 Week Follow-up]
• NIH Toolbox v3 [Срок оценки: Baseline, 7 Week Follow-up]

Вторичные конечные точки (8)

• Dysfunctional Beliefs and Attitudes about Sleep (DBAS) [Срок оценки: Baseline, 7 Week Follow-up, 12 Week Follow-up]
• Nightmare Disorder Index (NDI) [Срок оценки: Baseline, 7 Week Follow-up, 12 Week Follow-up]
• Epworth Sleepiness Scale (ESS) [Срок оценки: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up]
• Patient Health Questionnaire (PHQ-9) [Срок оценки: Baseline, 7 Week Follow-up, 12 Week Follow-up]
• Multidimensional Fatigue Inventory (MFI-20) [Срок оценки: Baseline, 7 Week Follow-up, 12 Week Follow-up]
• Headache Impact Test (HIT-6) [Срок оценки: Baseline, 7 Week Follow-up, 12 Week Follow-up]
• General Anxiety Disorder (GAD-7) [Срок оценки: Baseline, 7 Week Follow-up, 12 Week Follow-up]
• Depressive Symptoms Index-Suicidality Subscale (DSI-SS) [Срок оценки: Baseline, Treatment, 7 Week Follow-up, 12 Week Follow-up]

Критерии участия

Критерии включения

• Active duty U.S. military service members.
• At least 18 years of age.
• Ability to provide informed consent and follow study-related instructions.
• Self-report of a Mild Traumatic Brain Injury (mTBI) at least 3 months prior to enrollment based on self-report.
• At least 2 postconcussive symptoms scored > 2 (moderate) on the Neurobehavioral Symptom Inventory (NSI), with at least 1 of these symptoms from the cognitive domain in addition to the sleep disturbances item.
• Clinically significant chronic insomnia disorder assessed by an independent evaluator using the Structured Clinical Interview for Sleep Disorders-Revised (SCISD-R)\_No Split Week Self-Assessment of Sleep Survey (SASS-Y).
• Minimum score of 15 on the Insomnia Severity Index (ISI).
• Plans to be in the area for the next 3 months.
• Stable on psychotropic and hypnotic medications for at least 1 month.
• Stable on continuous positive airway pressure therapy if diagnosed with sleep apnea for at least 1 month.

Критерии исключения

• Moderate TBI (e.g., skull fracture, brain hemorrhage, hematoma) indicated by self-report or medical record.
• Any sleep, medical, or psychiatric disorder requiring urgent treatment (e.g., suicide risk, substance use, insomnia with occupational impairment in high risk professions; very short sleep duration of less than 4 hours on average; bipolar disorder or psychosis) or that otherwise interferes with the completion of the baseline assessment.
• Working night shifts (i.e., duty later than 9:00 pm or before 5:30 am) more than 3 times per month.
• Planned major surgery.
• Pregnancy, assessed by self-report and review of medical record.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Carl R. Darnall Army Medical Center — Fort Cavazos

Публикации

• Bramoweth AD, Lederer LG, Youk AO, Germain A, Chinman MJ. Brief Behavioral Treatment for Insomnia vs. Cognitive Behavioral Therapy for Insomnia: Results of a Randomized Noninferiority Clinical Trial Among Veterans. Behav Ther. 2020 Jul;51(4):535-547. doi: 10.1016/j.beth.2020.02.002. Epub 2020 Feb 20. PMID 32586428
• Pruiksma KE, Hale WJ, Mintz J, Peterson AL, Young-McCaughan S, Wilkerson A, Nicholson K, Dondanville KA, Fina BA, Borah EV, Roache JD, Litz BT, Bryan CJ, Taylor DJ; STRONG STAR Consortium. Predictors of Cognitive Behavioral Therapy for Insomnia (CBTi) Outcomes in Active-Duty U.S. Army Personnel. Behav Ther. 2020 Jul;51(4):522-534. doi: 10.1016/j.beth.2020.02.001. Epub 2020 Feb 14. PMID 32586427
• Mysliwiec V, Martin JL, Ulmer CS, Chowdhuri S, Brock MS, Spevak C, Sall J. The Management of Chronic Insomnia Disorder and Obstructive Sleep Apnea: Synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines. Ann Intern Med. 2020 Mar 3;172(5):325-336. doi: 10.7326/M19-3575. Epub 2020 Feb 18. PMID 32066145

Идентификаторы

NCT: NCT06551987 · STUDY00000222 · TP220139

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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