Insomnia, PrimarySPREADNCT02988375
Sleep to Prevent Evolving Affecting Disorders
A study testing dCBTI and Sleep Education in people with Insomnia, Primary and Depression, run by Henry Ford Health System at 1 site in United States.
Trial summary
The primary objective of the proposed research is to determine the efficacy of Digital Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Primary, Depression
- What is being tested?
- dCBTI and Sleep Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,385 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2016to 13 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia
Who cannot join
- Lack of insomnia, untreated sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome), bipolar disorder, history of seizure disorder, high depression chronicity (self-reported daily or near daily depressed mood and anhedonia)
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of the proposed research is to determine the efficacy of Digital Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. In addition, we will identify salient sociological/environmental variables, such as age, sex, education, socioeconomic status (SES), racial/ethnic minority-status, work schedule, child-care responsibilities (i.e., having children under the age of 3), stigma, that moderate the effects of this intervention.
Read the detailed description
The purpose of this study is to determine the effectiveness of Digital Cognitive Behavior Therapy for Insomnia (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. dCBTI is an online form of Cognitive Behavioral Therapy (CBT) used with people who experience trouble sleeping at night (insomniacs). This study will allow us to determine whether this form of digital therapy is helpful in reducing the severity of depression and in preventing the development and relapse of depression in people suffering from insomnia.
Participants will be recruited from several well-developed sources, including the HFHS Sleep Center Clinical database. Once a participant meets inclusion criteria and provides consent, a link to the internet portal will be provided to complete the remaining survey questions. After completion of this assessment, participants will be automatically randomized to one of 2 active online insomnia treatment conditions. Each treatment involves 6 weekly "sessions" which each take up to 20 minutes to complete.
A post-treatment questionnaire immediately following the 6-week treatment phase will be completed. In addition, a follow up questionnaire assessment will be completed approximately 1 year after treatment. Each of the 3 separate questionnaires will take 20-30 minutes to complete. Participants will be compensated.
- Conditions
- Insomnia, Primary, Depression
- Being tested
- dCBTI, Sleep Education
- Keywords
- insomnia, depression, digital CBTI, online CBTI
- 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.
dCBTIBehavioural
Sleep EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| dCBTI | Experimental | Online access to the digital CBTI program Sleepio Receives: Behavioral: dCBTI |
| Sleep Education | Placebo comparator | Weekly email messages with sleep hygiene recommendations Receives: Behavioral: Sleep Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression
Measured: Pre-treatment (Day 1)
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Measured: Post-treatment (~6 week after Screening)
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Measured: 1-year follow-up (58 week after screening)
Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)]
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Measured: Pre-treatment (Day 1)
Secondary outcomes (2)
Severity of Symptoms of Insomnia - Post Treatment
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Measured: Post-treatment (~6 week after Screening)
Severity of Symptoms of Insomnia - 1 Year Post Treatment
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
Measured: 1-year follow-up (58 week after screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start8 Mar 2016
- Primary completion26 Apr 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Christopher Drake, Henry Ford Health System
- Investigators
- Christopher Drake, PhD, Principal investigator, Henry Ford Medical Center - Columbus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988375
- Sponsor's protocol ID
- 10320
- Acronym
- SPREAD
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2016
- Last updated
- 12 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Russell JP, Teotia A, Kalmbach DA, Drake CL, Cheng P. Digital insomnia therapeutic as a workplace performance solution for improving productivity. Sleep Med. 2026 Jul;143:108896. doi: 10.1016/j.sleep.2026.108896. Epub 2026 Mar 11.
PubMed 41825236Cheng P, Kalmbach DA, Hsieh HF, Castelan AC, Sagong C, Drake CL. Improved resilience following digital cognitive behavioral therapy for insomnia protects against insomnia and depression one year later. Psychol Med. 2023 Jul;53(9):3826-3836. doi: 10.1017/S0033291722000472. Epub 2022 Mar 8.
PubMed 35257648Cheng P, Casement MD, Cuellar R, Johnson DA, Kalmbach D, Cuamatzi Castelan A, Drake CL. Sleepless in COVID-19: racial disparities during the pandemic as a consequence of structural inequity. Sleep. 2022 Jan 11;45(1):zsab242. doi: 10.1093/sleep/zsab242.
PubMed 34788453Cheng P, Casement MD, Kalmbach DA, Castelan AC, Drake CL. Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic. Sleep. 2021 Apr 9;44(4):zsaa258. doi: 10.1093/sleep/zsaa258.
PubMed 33249492Cheng P, Kalmbach DA, Tallent G, Joseph CL, Espie CA, Drake CL. Depression prevention via digital cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep. 2019 Oct 9;42(10):zsz150. doi: 10.1093/sleep/zsz150.
PubMed 31535688
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep to Prevent Evolving Affecting Disorders
- ClinicalTrials.gov ID
- NCT02988375
- Acronym / sponsor ID
- SPREAD / 10320
- Conditions
- Insomnia, Primary, Depression
- Keywords
- insomnia, depression, digital CBTI, online CBTI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,385 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 8 Mar 2016 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Posted 12 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the proposed research is to determine the efficacy of Digital Cognitive Behavior Therapy (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. In addition, we will identify salient sociological/environmental variables, such as age, sex, education, socioeconomic status (SES), racial/ethnic minority-status, work schedule, child-care responsibilities (i.e., having children under the age of 3), stigma, that moderate the effects of this intervention.
Detailed description
The purpose of this study is to determine the effectiveness of Digital Cognitive Behavior Therapy for Insomnia (dCBTI) in reducing severity of depression and also in preventing the incidence and relapse of depression among insomniacs. dCBTI is an online form of Cognitive Behavioral Therapy (CBT) used with people who experience trouble sleeping at night (insomniacs). This study will allow us to determine whether this form of digital therapy is helpful in reducing the severity of depression and in preventing the development and relapse of depression in people suffering from insomnia.
Participants will be recruited from several well-developed sources, including the HFHS Sleep Center Clinical database. Once a participant meets inclusion criteria and provides consent, a link to the internet portal will be provided to complete the remaining survey questions. After completion of this assessment, participants will be automatically randomized to one of 2 active online insomnia treatment conditions. Each treatment involves 6 weekly "sessions" which each take up to 20 minutes to complete.
A post-treatment questionnaire immediately following the 6-week treatment phase will be completed. In addition, a follow up questionnaire assessment will be completed approximately 1 year after treatment. Each of the 3 separate questionnaires will take 20-30 minutes to complete. Participants will be compensated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dCBTI | Experimental | Behavioral: dCBTIOnline access to the digital CBTI program Sleepio |
| Sleep Education | Placebo comparator | Behavioral: Sleep EducationWeekly email messages with sleep hygiene recommendations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia
Key exclusion criteria (1 listed)
- Lack of insomnia, untreated sleep disorder (e.g., obstructive sleep apnea, restless leg syndrome), bipolar disorder, history of seizure disorder, high depression chronicity (self-reported daily or near daily depressed mood and anhedonia)
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 |
|---|---|---|
| dCBTI | Behavioural | dCBTI |
| Sleep Education | Behavioural | Sleep Education |
Primary outcome
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment
Time frame: Pre-treatment (Day 1)
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity) and incidence of depression
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment
Time frame: Post-treatment (~6 week after Screening)
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up
Time frame: 1-year follow-up (58 week after screening)
Severity of depression as measured by the Quick Inventory of Depressive Symptomatology (QIDS; ranges 0-27 with higher scores meaning greater severity)
Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)]
Time frame: Pre-treatment (Day 1)
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)
2 secondary outcomes
Severity of Symptoms of Insomnia - Post Treatment
Time frame: Post-treatment (~6 week after Screening)
Severity of Symptoms of Insomnia - 1 Year Post Treatment
Time frame: 1-year follow-up (58 week after screening)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41825236Russell JP, Teotia A, Kalmbach DA, Drake CL, Cheng P. Digital insomnia therapeutic as a workplace performance solution for improving productivity. Sleep Med. 2026 Jul;143:108896. doi: 10.1016/j.sleep.2026.108896. Epub 2026 Mar 11.
- Derived from this study: PubMed 35257648Cheng P, Kalmbach DA, Hsieh HF, Castelan AC, Sagong C, Drake CL. Improved resilience following digital cognitive behavioral therapy for insomnia protects against insomnia and depression one year later. Psychol Med. 2023 Jul;53(9):3826-3836. doi: 10.1017/S0033291722000472. Epub 2022 Mar 8.
- Derived from this study: PubMed 34788453Cheng P, Casement MD, Cuellar R, Johnson DA, Kalmbach D, Cuamatzi Castelan A, Drake CL. Sleepless in COVID-19: racial disparities during the pandemic as a consequence of structural inequity. Sleep. 2022 Jan 11;45(1):zsab242. doi: 10.1093/sleep/zsab242.
- Derived from this study: PubMed 33249492Cheng P, Casement MD, Kalmbach DA, Castelan AC, Drake CL. Digital cognitive behavioral therapy for insomnia promotes later health resilience during the coronavirus disease 19 (COVID-19) pandemic. Sleep. 2021 Apr 9;44(4):zsaa258. doi: 10.1093/sleep/zsaa258.
- Derived from this study: PubMed 31535688Cheng P, Kalmbach DA, Tallent G, Joseph CL, Espie CA, Drake CL. Depression prevention via digital cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep. 2019 Oct 9;42(10):zsz150. doi: 10.1093/sleep/zsz150.
- Individual participant dataSharing planned: No
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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 Drake, PhD principal investigator
Henry Ford Medical Center - Columbus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dCBTI and Sleep Education in people with Insomnia, Primary and Depression, 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 1 inclusion and 1 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 12 Jan 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?
Yes. Results are posted in the registry (first posted 12 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment (time frame: Pre-treatment (Day 1)). 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 NCT02988375, which also lists 5 linked publications.
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 12 Jan 2024; AzTrials last refreshed its copy on 28 Oct 2026.