Placebo-controlled comparison of prazosin and cognitive-behavioral treatments for sleep disturbances in US Military Veterans

J Psychosom Res. 2012 Feb;72(2):89-96. doi: 10.1016/j.jpsychores.2011.11.010. Epub 2011 Dec 20.

Abstract

Objective: Pharmacological and cognitive-behavioral treatments targeting insomnia and nightmares have been shown to be effective in the treatment of military veterans with sleep complaints comorbid with symptoms of stress-related disorders, including Post-Traumatic Stress Disorder (PTSD), but the two approaches have not been directly compared. This randomized controlled trial compared the effects of prazosin vs. a behavioral sleep intervention (BSI), targeting nightmares and insomnia against a placebo pill control condition on sleep and daytime symptoms.

Methods: Fifty United States military veterans (mean age 40.9years, SD=13.2years) with chronic sleep disturbances were randomized to prazosin (n=18), BSI (n=17), or placebo (n=15). Each intervention lasted 8weeks. Participants completed self-report measures of insomnia severity, sleep quality, and sleep disturbances. All kept a sleep diary throughout the intervention period. Polysomnographic studies were conducted pre- and post-intervention.

Results: Both active treatment groups showed greater reductions in insomnia severity and daytime PTSD symptom severity. Sleep improvements were found in 61.9% of those who completed the active treatments and 25% of those randomized to placebo.

Conclusion: BSI and prazosin were both associated with significant sleep improvements and reductions in daytime PTSD symptoms in this sample of military veterans. Sleep-focused treatments may enhance the benefits of first-line PTSD treatments.

Trial registration: ClinicalTrials.gov NCT00393874.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adrenergic alpha-1 Receptor Antagonists / pharmacology
  • Adrenergic alpha-1 Receptor Antagonists / therapeutic use*
  • Adult
  • Cognitive Behavioral Therapy*
  • Combat Disorders / drug therapy
  • Combat Disorders / psychology
  • Combat Disorders / therapy*
  • Double-Blind Method
  • Dreams / drug effects
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prazosin / pharmacology
  • Prazosin / therapeutic use*
  • Severity of Illness Index
  • Sleep Wake Disorders / drug therapy
  • Sleep Wake Disorders / psychology
  • Sleep Wake Disorders / therapy*
  • Stress Disorders, Post-Traumatic / drug therapy
  • Stress Disorders, Post-Traumatic / psychology
  • Stress Disorders, Post-Traumatic / therapy*
  • Treatment Outcome
  • Veterans / psychology

Substances

  • Adrenergic alpha-1 Receptor Antagonists
  • Prazosin

Associated data

  • ClinicalTrials.gov/NCT00393874