CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Conditions

• Brain Injury Traumatic Mild
• Cognitive Behavioral Therapy
• Concussion, Brain
• Depression
• Head Injury
• Insomnia
• Memory Impairment
• Post-traumatic Stress
• Sleep
• Traumatic Brain Injury

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mindfulness-based treatment for insomnia (MBTI) — BEHAVIORAL
  A 6-week intervention that uses the principles and practices of mindfulness meditation along with behavioral strategies (stimulus control, sleep restriction therapy) to reduce symptoms of insomnia
• Cognitive behavioral therapy for insomnia (CBT-I) — BEHAVIORAL
  Standard of care for adults with chronic insomnia. 6-week program that uses behavioral techniques to decrease psychophysiological arousal and increase sleep propensity to deepen and consolidate sleep.

Study Details

This study is a prospective two-arm, single blind randomized controlled trial design to compare the clinical effectiveness of telemedicine-delivered, 6-session, standardized cognitive behavioral therapy for insomnia (CBT-I) and mindfulness-based treatment for insomnia (MBTI) in treating insomnia symptoms and ameliorating depressive symptoms in persons with mild to moderate TBI and comorbid Post-Traumatic Stress Symptoms (PTSS) and insomnia symptoms in a 360 patients. Participants will undergo assessment (psychosocial questionnaires, neurocognitive testing, sleep monitoring) at baseline, at the end of treatment, and at 2-, 6- and 12-weeks post-treatment. The primary outcome is sleep as measured by the Insomnia Severity Index (ISI).

Key Dates

Start date

May 10, 2024

Status verified

May 2026

Primary completion

Sep 30, 2026

Completion

Sep 30, 2026

Study Design

Enrollment

360 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Cognitive behavioral therapy for insomnia (CBT-I)
  CBT-I treatment will involve a standardized 6-session blended intervention that combines cognitive and behavioral techniques. The core components include (1) education about sleep and insomnia, stimulus control (SC) and sleep restriction (SRT) (week 1); (2) sleep hygiene education (week 2); and (3) relaxation training, cognitive restructuring (to counter-arousal and address sleep-interfering cognitions), adherence monitoring, and adjusting the recommended sleep-wake schedule (weeks 3 through 6). The final session will also include a review of treatment content and relapse prevention. Common to all sessions is an initial review of participant diary data, charting progress, setting measurable goals, discussing adherence, and reinforcing learned skills.
• Active Comparator: Mindfulness-based treatment for insomnia (MBTI)
  MBTI treatment will involve a standardized 6-session intervention which integrates the mindfulness training and exercises from mindfulness-based stress reduction (MBSR) with behavioral strategies based on sleep restriction therapy and stimulus control delivered within the context of mindfulness principles. Mindfulness principles include: 1) increase awareness of the mental and physical states that promote sleep (i.e., sleepiness), 2) shift sleep-related metacognitions to reduce hyperarousal, and 3) promote a mindful stance to respond when symptoms of insomnia arise. An overview of the treatment program, sleep education, and an introduction to the principles of mindfulness meditation is given (week 1). Then a combination of mindfulness meditations, sleep restriction, and stimulus control is conducted (week 2-6).

Primary Outcome Measure

Change in Insomnia severity as assessed by the insomnia severity index (ISI) [ Time Frame: At the end of treatment, and 2-, 6- and 12-weeks post treatment ]

Central Contacts

• Luis Buenaver, PHD
  4105507986
  [email protected]
• Elizabeth Wysocki, MS
  [email protected]

Locations (5)

Find similar trials in Eglin Air Force Base, FL

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