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Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia

January 7, 2021

Overview

The Comparison of Efficacy of Behavioral Approaches for Treatment of Insomnia study aims to compare the effectiveness of four different therapies for insomnia: CBT, FOA, combined CBT and FOA, and Sleep Hygiene. 

 

Study Information 

Patients will undergo either Cognitive Behavioral Therapy (CBT), Focus of Attention (FOA), combined CBT and FOA or Sleep Hygiene (acting as a control group) during 6 weekly sessions of one hour. Assigned therapy will be randomized. At the end of the treatment period, participants will then report any improvements in their insomnia as well as 3, 6 and 12 months later. All participants must meet the DSM-5 diagnostic criteria for insomnia. 

 

Inclusion Criteria:

 

  • Male and female outpatients aged 18 or older, up to 72 years.
  • Has an Insomnia Severity Index greater than or equal to 10
  • Meets the diagnostic criteria for Insomnia Disorder per DSM-5 
  • Is willing and able to sign an informed consent form 
  • Does not plan on relocating at any time during the next 12 weeks

 

Exclusion Criteria:

 

  • Pregnant or lactating women 
  • Individuals who work night shifts and individuals who took naps 3 or more times per week in the month prior to the start of study
  • Drinks more than 5 servings of caffeinated beverages per day
  • Is currently enrolled in another insomnia study
  • Is unable to complete study questionnaires and psychological exams
  • Is unable to comply with the study’s obligations
  • Has severe anxiety (BAI >= 36) or depression (BDI >=29)
  • Has a history of epilepsy, seizures or dementia 
  • Has a severe, unstable or chronically progressing medical condition
  • Has suffered a serious head injury or stroke in the past year
  • Suffers from current alcohol addiction or dependence – must be sober for more than 90 days
  • Has any other neurological disorders such as multiple sclerosis or Parkinson’s disease
  • Has an untreated or unstable psychiatric condition that has required hospital admission in the last two years. Those currently taking psychotropic medications are allowed to participate if they have taken a stable dosage in the 2 months before the study and if their medication does not affect the study outcome. 
  • Takes medications or drugs that may cause insomnia
  • Has sleep apnea (AHI score > 15). If participant uses a CPAP device, they are allowed to take part in the study if they fall below the apnea / hypopnea cutoff and use their device throughout the duration of the study. 

 

Locations

Puget Sound Psychiatric Center

Bothell, Washington, United States

 

Sponsors / Collaborators

Pacific Institute of Medical Sciences

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