Status:
COMPLETED
CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Insomnia
Depression
Eligibility:
All Genders
12-19 years
Phase:
NA
Brief Summary
This study is a randomized controlled trial that tests the effectiveness of cognitive behavior therapy (CBT) for insomnia with comorbid depression in youth aged 12 through 19 who have recently begun s...
Detailed Description
160 youth with depression and comorbid insomnia who have just initiated a course of SSRI antidepressants will be randomized to insomnia-focused cognitive behavior therapy (CBT-I) or an attention contr...
Eligibility Criteria
Inclusion
- Age 12 to 19
- Major depression based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria
- Recent dispense of SSRI antidepressant
- Subjective complaint of insomnia ≥ one month
- Score of ≥ 9 on Insomnia Severity Index
Exclusion
- Active, progressive physical illness or neurological degenerative disease
- Sleep apnea, restless legs, or limb movements during sleep
- Diagnosis of delayed sleep phase syndrome (DSPS)
- Mental retardation, autism spectrum disorder (ASD), or other significant pervasive developmental disability (PDD)
- Sleep treatments including over-the-counter (OTC) sleep medication or CBT for insomnia
- Medications known to alter sleep
- Diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT02290496
Start Date
March 1 2015
End Date
July 1 2018
Last Update
December 17 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kaiser Permanente Center for Health Research/Northwest
Portland, Oregon, United States, 97227