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