CoMBat Insomnia: A Randomized Controlled Trial of Cognitive-Behavioral vs. Mindfulness-Based Treatment for TBI-Related Insomnia and Post-Traumatic Stress Symptoms

Summary

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).

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Behavioral
  Mindfulness-based treatment for insomnia (MBTI)

  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

• Behavioral
  Cognitive behavioral therapy for insomnia (CBT-I)

  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.

Locations (5)