Insomnia, PrimarySTRIDENCT03322774
Sleep To Reduce Incident Depression Effectively
A study testing digital Cognitive Behavioral Therapy for Insomnia and face-to-face Cognitive Behavioral Therapy for Insomnia in people with Insomnia, Primary and Major Depressive Disorder, run by Henry Ford Health System at 1 site in United States.
Trial summary
This project will assess the effectiveness of a stepped-care model (i.e. digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) followed by face-to-face CBT-I) in improving severity of insomnia and sleep outcomes in an insomnia cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Primary, Major Depressive Disorder, Rumination
- What is being tested?
- digital Cognitive Behavioral Therapy for Insomnia and face-to-face Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,237 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2018to 27 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Determination of Insomnia (ISI > 14)
- And no clinically significant depressive symptoms (Quick Inventory of Depressive Symptomatology < 11)
Who cannot join
- Age < 18
- Current use of antidepressants for depression
- Bipolar or Seizure disorders
- Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).
- Current DSM-5 major depressive disorder at baseline.
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
About this study
This project will assess the effectiveness of a stepped-care model (i.e. digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) followed by face-to-face CBT-I) in improving severity of insomnia and sleep outcomes in an insomnia cohort. This project will also investigate the effectiveness of this stepped-care model in prevention of major depressive disorder, and will test rumination as a mediator of treatment response.
Read the detailed description
This project will assess the acute and long-term effectiveness of dCBT-I on Research Domain Criteria (RDoC) sleep parameters: Insomnia Severity Index (ISI), sleep onset latency, and wake after sleep onset in an insomnia cohort including those at elevated risk for depression (e.g. low SES, minority). This will be tested by administering internet-based dCBT-I to people with insomnia and adding face-to-face CBT-I in non-remitters, as well as comparing the RDoC sleep outcomes to an attention control group post-treatment and at 1- and 2-year follow-ups. This study will also determine the acute and long-term effectiveness of face-to-face CBT-I in non-responders to dCBT-I on RDoC sleep outcomes relative to a comparison group post-treatment and at 1- and 2-year follow-ups.
This study will also determine the effects of dCBT-I and CBT-I using a stepped-care model for prevention of major depressive disorder incidence and relapse across 2 years. Specifically, rate of depression of both dCBT-I and CBT-I will be compared to a control group.
This study will also evaluate changes in rumination as a modifiable behavior (post-treatment) that mediates the effect of insomnia treatment on depression risk.
- Conditions
- Insomnia, Primary, Major Depressive Disorder, Rumination
- Being tested
- digital Cognitive Behavioral Therapy for Insomnia, face-to-face Cognitive Behavioral Therapy for Insomnia, Sleep Hygiene Education Control
- Keywords
- Stepped Care
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depressive Disorder, Major, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital Cognitive Behavioral Therapy for InsomniaBehavioural
Also called Sleepio, dCBT-I
Cognitive Behavioral Therapy for Insomnia administered online through the "Sleepio" program. Treatment utilizes sleep restriction, stimulus control, and cognitive therapy. Treatment is administered through 6 weekly, hour-long online video sessions with an animated figure called "The Prof," which delivers the treatment.
face-to-face Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
Cognitive Behavioral Therapy for Insomnia administered by experienced staff trained in behavioral sleep medicine. Treatment utilizes sleep restriction, stimulus control, and cognitive therapy. Treatment is administered through 6 weekly, hour-long face-to-face sessions with an experienced staff member trained in behavioral sleep medicine.
Sleep Hygiene Education ControlBehavioural
Participants are provided with information about good sleep hygiene through 6 weekly emails. Participants practice good sleep hygiene as part of their sleep routine. In Step 1, sleep hygiene control will be exclusively online. In Step 2, sleep hygiene control includes an in-person, face-to-face component.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | Sham comparator | This group receives sleep hygiene education, which serves as a credible control intervention to digital cognitive behavioral therapy for insomnia (dCBT-I). This intervention mimics the web-based patient contact inherent in dCBT-I but is inert with respect to sleep outcomes. Receives: Behavioral: Sleep Hygiene Education Control |
| Stepped Care Model | Experimental | This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Following initial treatment with dCBT-I, individuals who do not experience remission of their insomnia will begin treatment with face-to-face Cognitive Behavioral Therapy for Insomnia with a trained staff member in behavioral sleep medicine. Receives: Behavioral: digital Cognitive Behavioral Therapy for Insomnia; Behavioral: face-to-face Cognitive Behavioral Therapy for Insomnia |
| Stepped Care Model Control | Sham comparator | This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Following initial treatment with dCBT-I, individuals who do not experience remission of their insomnia will receive sleep hygiene education, serving as a credible control intervention for comparison to the Stepped Care Model. Receives: Behavioral: digital Cognitive Behavioral Therapy for Insomnia; Behavioral: Sleep Hygiene Education Control |
| digital CBT-I | Experimental | This group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Treatment includes weekly sessions of CBT-I administered over the internet in hour-long video sessions. Daily sleep diaries are recorded online for individual tailoring of treatment. Receives: Behavioral: digital Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventing major depressive disorder development with dCBT-I/CBT-I stepped care treatment for insomnia.
Clinical interview by phone administered by trained personnel to determine DSM-5 major depressive disorder incidence and relapse. Major depressive disorder will specifically be determined by the structured clinical interview for DSM-5 (SCID-5) at 1- and 2-year follow-ups. Antidepressant history in the past 1 year is collected via online-administered surveys at 1- and 2-year follow-ups.
Measured: 1 and 2 years after initial randomization.
Effectiveness of Stepped Care model of dCBT-I/CBT-I for insomnia remission.
Insomnia remission rates based on the Insomnia Severity Index. Total score range 0-28 with higher scores meaning more insomnia. Remission = ISI < 8.
Measured: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Mediation of Depression Prevention by Reducing Rumination (Nocturnal rumination)
Rumination as measured by the Pre-Sleep Arousal Scale, Cognitive factor. Scores range from 8 to 40 with higher scores indicating more rumination. Treatment-related changes in rumination will be operationalized as changes from pre- to posttreatment.
Measured: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Secondary outcomes (7)
Mediation of Depression Prevention by Reducing Rumination (Depressive rumination)
Rumination as determined by the Rumination Response Scale. Scores range from 22-88 with higher scores indicating higher depressive rumination. Treatment-related changes in rumination will be operationalized as changes from pre- to posttreatment.
Measured: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Mediation of Depression Prevention by Reducing Rumination (Worry)
Rumination as determined by the Penn State Worry Questionnaire. Scores range from 16-80 with higher scores indicating greater worry. Treatment-related changes in rumination will be operationalized as changes from pre- to posttreatment.
Measured: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Mediation of Depression Prevention by Reducing Rumination (Transdiagnostic)
Rumination as determined by the Perseverative Thinking Questionnaire. Scores range from 15-75 with higher scores indicating greater perseverative thinking. Treatment-related changes in rumination will be operationalized as changes from pre- to posttreatment.
Measured: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Reducing subclinical depressive symptoms with dCBT-I/CBT-I stepped care treatment for insomnia.
Depressive symptoms as measured by the Quick Inventory of Depressive Sympatomatology, 16 item self report version. Reductions in depressive symptoms will be operationalized as (1) pre to posttreatment changes, (2) pretreatment to 1-year follow-up changes, and (3) pretreatment to 2-year follow-up changes.
Measured: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Socioeconomic status as a moderator of depression prevention after stepped care insomnia treatment.
Low socioeconomic status will be defined as annual household income < $20,000. Stepped care treatment will be less effective for preventing depression for patients in poverty as compared to patients above the the poverty line.
Measured: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Racial minority identification as a moderator of depression prevention after stepped care insomnia treatment.
Race will be self reported by patients. Stepped care treatment will be less effective for preventing depression for patients who self-identify as racial minorities (e.g., non-Hispanic black) relative to non-Hispanic white patients.
Measured: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Stepped care insomnia treatment of dCBT-I and CBT-I will significantly improve sleep parameters.
Sleep parameters as captured by self-reported sleep onset latency, wake after sleep onset, and sleep efficiency.
Measured: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start9 Mar 2018
- Primary completion30 Apr 2023
- Study completion27 Jun 2024
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 Insomnia, PrimaryStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Big Health Inc., University of Michigan
- Responsible party
- Principal investigator, Christopher Drake, Henry Ford Health System
- Investigators
- Christopher L Drake, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322774
- Sponsor's protocol ID
- IRB 11586
- Acronym
- STRIDE
- Status last verified
- Sep 2024
- First submitted
- 16 Oct 2017
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Drake CL, Kalmbach DA, Cheng P, Ahmedani BK, Peterson EL, Joseph CLM, Roth T, Kidwell KM, Sagong C. Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression. Trials. 2022 Dec 1;23(1):967. doi: 10.1186/s13063-022-06850-4.
PubMed 36457045
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep To Reduce Incident Depression Effectively
- ClinicalTrials.gov ID
- NCT03322774
- Acronym / sponsor ID
- STRIDE / IRB 11586
- Conditions
- Insomnia, Primary, Major Depressive Disorder, Rumination
- Keywords
- Stepped Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,237 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Big Health Inc., University of Michigan
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 26 Oct 2017 (actual)
- 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 project will assess the effectiveness of a stepped-care model (i.e. digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) followed by face-to-face CBT-I) in improving severity of insomnia and sleep outcomes in an insomnia cohort. This project will also investigate the effectiveness of this stepped-care model in prevention of major depressive disorder, and will test rumination as a mediator of treatment response.
Detailed description
This project will assess the acute and long-term effectiveness of dCBT-I on Research Domain Criteria (RDoC) sleep parameters: Insomnia Severity Index (ISI), sleep onset latency, and wake after sleep onset in an insomnia cohort including those at elevated risk for depression (e.g. low SES, minority). This will be tested by administering internet-based dCBT-I to people with insomnia and adding face-to-face CBT-I in non-remitters, as well as comparing the RDoC sleep outcomes to an attention control group post-treatment and at 1- and 2-year follow-ups. This study will also determine the acute and long-term effectiveness of face-to-face CBT-I in non-responders to dCBT-I on RDoC sleep outcomes relative to a comparison group post-treatment and at 1- and 2-year follow-ups.
This study will also determine the effects of dCBT-I and CBT-I using a stepped-care model for prevention of major depressive disorder incidence and relapse across 2 years. Specifically, rate of depression of both dCBT-I and CBT-I will be compared to a control group.
This study will also evaluate changes in rumination as a modifiable behavior (post-treatment) that mediates the effect of insomnia treatment on depression risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Sham comparator | Behavioral: Sleep Hygiene Education ControlThis group receives sleep hygiene education, which serves as a credible control intervention to digital cognitive behavioral therapy for insomnia (dCBT-I). This intervention mimics the web-based patient contact inherent in dCBT-I but is inert with respect to sleep outcomes. |
| Stepped Care Model | Experimental | Behavioral: digital Cognitive Behavioral Therapy for Insomnia, Behavioral: face-to-face Cognitive Behavioral Therapy for InsomniaThis group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Following initial treatment with dCBT-I, individuals who do not experience remission of their insomnia will begin treatment with face-to-face Cognitive Behavioral Therapy for Insomnia with a trained staff member in behavioral sleep medicine. |
| Stepped Care Model Control | Sham comparator | Behavioral: digital Cognitive Behavioral Therapy for Insomnia, Behavioral: Sleep Hygiene Education ControlThis group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Following initial treatment with dCBT-I, individuals who do not experience remission of their insomnia will receive sleep hygiene education, serving as a credible control intervention for comparison to the Stepped Care Model. |
| digital CBT-I | Experimental | Behavioral: digital Cognitive Behavioral Therapy for InsomniaThis group receives digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) through the third party program, "Sleepio." Treatment includes weekly sessions of CBT-I administered over the internet in hour-long video sessions. Daily sleep diaries are recorded online for individual tailoring of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Determination of Insomnia (ISI > 14)
- And no clinically significant depressive symptoms (Quick Inventory of Depressive Symptomatology < 11)
Key exclusion criteria (5 listed)
- Age < 18
- Current use of antidepressants for depression
- Bipolar or Seizure disorders
- Known sleep disorders other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless leg syndrome).
- Current DSM-5 major depressive disorder at baseline.
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 |
|---|---|---|
| digital Cognitive Behavioral Therapy for InsomniaAlso: Sleepio, dCBT-ICognitive Behavioral Therapy for Insomnia administered online through the "Sleepio" program. Treatment utilizes sleep restriction, stimulus control, and cognitive therapy. Treatment is administered through 6 weekly, hour-long online video sessions with an animated figure called "The Prof," which delivers the treatment. | Behavioural | Stepped Care Model, Stepped Care Model Control, digital CBT-I |
| face-to-face Cognitive Behavioral Therapy for InsomniaAlso: CBT-ICognitive Behavioral Therapy for Insomnia administered by experienced staff trained in behavioral sleep medicine. Treatment utilizes sleep restriction, stimulus control, and cognitive therapy. Treatment is administered through 6 weekly, hour-long face-to-face sessions with an experienced staff member trained in behavioral sleep medicine. | Behavioural | Stepped Care Model |
| Sleep Hygiene Education ControlParticipants are provided with information about good sleep hygiene through 6 weekly emails. Participants practice good sleep hygiene as part of their sleep routine. In Step 1, sleep hygiene control will be exclusively online. In Step 2, sleep hygiene control includes an in-person, face-to-face component. | Behavioural | Attention Control, Stepped Care Model Control |
Primary outcome
Preventing major depressive disorder development with dCBT-I/CBT-I stepped care treatment for insomnia.
Time frame: 1 and 2 years after initial randomization.
Clinical interview by phone administered by trained personnel to determine DSM-5 major depressive disorder incidence and relapse. Major depressive disorder will specifically be determined by the structured clinical interview for DSM-5 (SCID-5) at 1- and 2-year follow-ups. Antidepressant history in the past 1 year is collected via online-administered surveys at 1- and 2-year follow-ups.
Effectiveness of Stepped Care model of dCBT-I/CBT-I for insomnia remission.
Time frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Insomnia remission rates based on the Insomnia Severity Index. Total score range 0-28 with higher scores meaning more insomnia. Remission = ISI < 8.
Mediation of Depression Prevention by Reducing Rumination (Nocturnal rumination)
Time frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Rumination as measured by the Pre-Sleep Arousal Scale, Cognitive factor. Scores range from 8 to 40 with higher scores indicating more rumination. Treatment-related changes in rumination will be operationalized as changes from pre- to posttreatment.
7 secondary outcomes
Mediation of Depression Prevention by Reducing Rumination (Depressive rumination)
Time frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Mediation of Depression Prevention by Reducing Rumination (Worry)
Time frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Mediation of Depression Prevention by Reducing Rumination (Transdiagnostic)
Time frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Reducing subclinical depressive symptoms with dCBT-I/CBT-I stepped care treatment for insomnia.
Time frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Socioeconomic status as a moderator of depression prevention after stepped care insomnia treatment.
Time frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Racial minority identification as a moderator of depression prevention after stepped care insomnia treatment.
Time frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
Stepped care insomnia treatment of dCBT-I and CBT-I will significantly improve sleep parameters.
Time frame: Baseline, upon treatment completion, and then 1 and 2 years after initial randomization.
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 1 Oct 2024.
- Derived from this study: PubMed 36457045Drake CL, Kalmbach DA, Cheng P, Ahmedani BK, Peterson EL, Joseph CLM, Roth T, Kidwell KM, Sagong C. Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression. Trials. 2022 Dec 1;23(1):967. doi: 10.1186/s13063-022-06850-4.
- Individual participant dataSharing planned: Undecided
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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.
Christopher L Drake, PhD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital Cognitive Behavioral Therapy for Insomnia and face-to-face Cognitive Behavioral Therapy for Insomnia in people with Insomnia, Primary and Major Depressive Disorder, run by Henry Ford Health System 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 2 inclusion and 5 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 1 Oct 2024. 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?
Preventing major depressive disorder development with dCBT-I/CBT-I stepped care treatment for insomnia. (time frame: 1 and 2 years after initial randomization.). The study lists 3 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 NCT03322774, 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 1 Oct 2024.