InsomniaSleepWellNCT02290496
CBT Insomnia Teens: Augmenting SSRIs to Improve Youth Depression
A study testing CBT for Insomnia (CBT-I) and Sleep Hygiene (SH) in people with Insomnia and Depression, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Insomnia, Depression
- What is being tested?
- CBT for Insomnia (CBT-I) and Sleep Hygiene (SH)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Center for Health Research/Northwest
Portland, Oregon, 97227
About this study
Official title: CBT Insomnia Teens: Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes
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.
Read the 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.
- Conditions
- Insomnia, Depression
- Being tested
- CBT for Insomnia (CBT-I), Sleep Hygiene (SH)
- Keywords
- Insomnia, Depression, Teen, SSRI, CBT, Youth
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for Insomnia (CBT-I)Behavioural
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.
Sleep Hygiene (SH)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT for Insomnia (CBT-I) | Experimental | Cognitive behavior therapy to improve sleep and depression. Receives: Behavioral: CBT for Insomnia (CBT-I) |
| Sleep Hygiene (SH) | Placebo comparator | Attention control placebo comprising sleep hygiene therapy Receives: Behavioral: Sleep Hygiene (SH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 52 weeks from baseline
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).
Measured: 52 weeks from baseline
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.
Measured: 52 weeks from baseline
Severity of insomnia based on ISI
Insomnia severity is measured by the Insomnia Severity Index (ISI)
Measured: 52 weeks from baseline
Secondary outcomes (1)
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)
Measured: 52 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gregory N. Clarke, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290496
- Sponsor's protocol ID
- R01MH104647
- Other IDs
- R01MH104647
- Acronym
- SleepWell
- Status last verified
- Dec 2018
- First submitted
- 28 Oct 2014
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32114185
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT Insomnia Teens: Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes
- ClinicalTrials.gov ID
- NCT02290496
- Acronym / sponsor ID
- SleepWell / R01MH104647
- Conditions
- Insomnia, Depression
- Keywords
- Insomnia, Depression, Teen, SSRI, CBT, Youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT for Insomnia (CBT-I) | Experimental | Behavioral: CBT for Insomnia (CBT-I)Cognitive behavior therapy to improve sleep and depression. |
| Sleep Hygiene (SH) | Placebo comparator | Behavioral: Sleep Hygiene (SH)Attention control placebo comprising sleep hygiene therapy |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT for Insomnia (CBT-I)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. | Behavioural | CBT for Insomnia (CBT-I) |
| Sleep Hygiene (SH)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. | Behavioural | Sleep Hygiene (SH) |
Primary outcome
Improvement in depression and current severity of depression
Time frame: 52 weeks from baseline
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)
Time frame: 52 weeks from baseline
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
Time frame: 52 weeks from baseline
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
Time frame: 52 weeks from baseline
Insomnia severity is measured by the Insomnia Severity Index (ISI)
1 secondary outcome
Severity of depression based on CDRS-R and PHQ-9
Time frame: 52 weeks from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Derived from this study: PubMed 32114185Clarke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory N. Clarke, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT for Insomnia (CBT-I) and Sleep Hygiene (SH) in people with Insomnia and Depression, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in depression and current severity of depression (time frame: 52 weeks from baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02290496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.