Clinical trial NCT02290496: CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression
Official title: CBT Insomnia Teens: Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Depression
Keywords: Insomnia
Depression
Teen
SSRI
CBT
Youth
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-11-14
Enrollment: 165
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 selective serotonin re-uptake inhibitor (SSRI) antidepressants. CBT is compared with a control condition of sleep hygiene education.

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 control condition of sleep hygiene (SH) education. All participants will have in-person treatment sessions and will complete sleep diaries and wear an actigraph to record activity levels. Participants will be followed for 12 months.

Primary depression outcomes are score on the Clinical Global Impressions Improvement (CGI-I) and major depressive disorder diagnostic remission; primary sleep outcomes are actigraphy total sleep time and score on the Insomnia Severity Index (ISI). Secondary outcomes include additional sleep and depression outcomes. The study will also include economic analyses.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Improvement in depression and current severity of depression
timeFrame: 52 weeks from baseline
measure: Psychiatric Status Ratings (PSRs) for major depressive disorder (MDD)
timeFrame: 52 weeks from baseline
measure: Increase in total sleep time across the study period
timeFrame: 52 weeks from baseline
measure: Severity of insomnia based on ISI
timeFrame: 52 weeks from baseline
Secondary outcomes:
measure: Severity of depression based on CDRS-R and PHQ-9
timeFrame: 52 weeks from baseline
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research/Northwest
state: Oregon
Study officials:
affiliation: Kaiser Permanente
name: Gregory N. Clarke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clarke G, Sheppler CR, Firemark AJ, Rawlings AM, Dickerson JF, Leo MC. Augmenting usual care SSRIs with cognitive behavioral therapy for insomnia to improve depression outcomes in youth: Design of a randomized controlled efficacy-effectiveness trial. Contemp Clin Trials. 2020 Apr;91:105967. doi: 10.1016/j.cct.2020.105967. Epub 2020 Feb 28.