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CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression (SleepWell)

Primary Purpose

Insomnia, Depression

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBT for Insomnia (CBT-I)

Sleep Hygiene (SH)

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Depression, Teen, SSRI, CBT, Youth

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaiser Permanente Center for Health Research/Northwest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBT for Insomnia (CBT-I)

Sleep Hygiene (SH)

Arm Description

Cognitive behavior therapy to improve sleep and depression.

Attention control placebo comprising sleep hygiene therapy

Outcomes

Primary Outcome Measures

Improvement in depression and current severity of depression

Improvement in depression is measured by the Clinical Global Impression-Improvement (CGI-I), and severity is measured by the Clinical Global Impression-Severity (CGI-S).

Psychiatric Status Ratings (PSRs) for major depressive disorder (MDD)

PSRs will be measured using the Children's Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and Longitudinal and Interval Follow-up Evaluation (LIFE).

Increase in total sleep time across the study period

Total sleep time is calculated from a sleep diary, which participants complete for 2 weeks following each assessment and during active sleep treatment, and from ActiGraph devices, which measure total sleep time and physical activity 24 hours per day during active sleep treatment and for 2 weeks following each assessment.

Severity of insomnia based on ISI

Insomnia severity is measured by the Insomnia Severity Index (ISI)

Secondary Outcome Measures

Severity of depression based on CDRS-R and PHQ-9

Severity of depression is measured by the Children's Depression Rating Scale-Revised (CDRS-R) and the Patient Health Questionnaire-Depression (PHQ-9)

Full Information

NCT ID

NCT02290496

First Posted

October 28, 2014

Last Updated

December 13, 2018

Sponsor

Kaiser Permanente

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT02290496

Brief Title

CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

Acronym

SleepWell

Official Title

CBT Insomnia Teens: Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

March 2015 (Actual)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaiser Permanente

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Depression

Keywords

Insomnia, Depression, Teen, SSRI, CBT, Youth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT for Insomnia (CBT-I)

Arm Type

Experimental

Arm Description

Cognitive behavior therapy to improve sleep and depression.

Arm Title

Sleep Hygiene (SH)

Arm Type

Placebo Comparator

Arm Description

Attention control placebo comprising sleep hygiene therapy

Intervention Type

Behavioral

Intervention Name(s)

CBT for Insomnia (CBT-I)

Intervention Description

Cognitive behavior therapy for insomnia (CBT-I) comprising stimulus control, sleep restriction, and sleep-focused cognitive therapy. The CBT-I consists of in-person sessions and homework assignments and includes stimulus control and sleep restriction to regularize the sleep-wake cycle; cognitive therapy to address dysfunctional sleep beliefs and bedtime rumination; motivational interviewing to help youth make important health changes; and parental involvement. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.

Intervention Type

Behavioral

Intervention Name(s)

Sleep Hygiene (SH)

Intervention Description

Attention placebo control focusing on sleep hygiene, consisting of in-person sessions and homework assignments. The sleep hygiene sessions address sleep-related topics such as limiting pre-sleep caffeine intake, sleep-promoting activities, and the impacts of insufficient sleep. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.

Primary Outcome Measure Information:

Title

Improvement in depression and current severity of depression

Description

Improvement in depression is measured by the Clinical Global Impression-Improvement (CGI-I), and severity is measured by the Clinical Global Impression-Severity (CGI-S).

Time Frame

52 weeks from baseline

Title

Psychiatric Status Ratings (PSRs) for major depressive disorder (MDD)

Description

PSRs will be measured using the Children's Schedule for Affective Disorders and Schizophrenia (KSADS-PL) and Longitudinal and Interval Follow-up Evaluation (LIFE).

Time Frame

52 weeks from baseline

Title

Increase in total sleep time across the study period

Description

Time Frame

52 weeks from baseline

Title

Severity of insomnia based on ISI

Description

Insomnia severity is measured by the Insomnia Severity Index (ISI)

Time Frame

52 weeks from baseline

Secondary Outcome Measure Information:

Title

Severity of depression based on CDRS-R and PHQ-9

Description

Severity of depression is measured by the Children's Depression Rating Scale-Revised (CDRS-R) and the Patient Health Questionnaire-Depression (PHQ-9)

Time Frame

52 weeks from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory N. Clarke, PhD

Organizational Affiliation

Kaiser Permanente

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaiser Permanente Center for Health Research/Northwest

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32114185

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.

Results Reference

derived

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CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression

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