Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Robert Wood Johnson Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dCBTI | Experimental | Online access to the digital CBTI program Sleepio |
|
| Sleep Education | Placebo Comparator | Weekly email messages with sleep hygiene recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dCBTI | Behavioral |
| ||
| Sleep Education |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 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) | 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) | Pre-treatment (Day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Symptoms of Insomnia - Post Treatment | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity) | Post-treatment (~6 week after Screening) |
| Severity of Symptoms of Insomnia - 1 Year Post Treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christopher Drake, PhD | Henry Ford Medical Center - Columbus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41825236 | Derived | 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. | |
| 35257648 | Derived | Cheng 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | dCBTI | Online access to the digital CBTI program Sleepio dCBTI |
| FG001 | Sleep Education | Weekly email messages with sleep hygiene recommendations Sleep Education |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | dCBTI | Online access to the digital CBTI program Sleepio dCBTI |
| BG001 | Sleep Education | Weekly email messages with sleep hygiene recommendations Sleep Education |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (Day 1) |
|
AE not reported.
The definition of adverse event and/or serious adverse event doesn't differ from the clinicaltrials.gov.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | dCBTI | Online access to the digital CBTI program Sleepio dCBTI | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christopher Drake | Henry Ford Health | (248) 344-6672 | cdrake1@hfhs.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2016 | Dec 14, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2018 | Dec 14, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity) |
| 1-year follow-up (58 week after screening) |
| 34788453 | Derived | Cheng 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. |
| 33249492 | Derived | Cheng 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. |
| 31535688 | Derived | Cheng 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | score on a scale | Post-treatment (~6 week after Screening) |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | score on a scale | 1-year follow-up (58 week after screening) |
|
|
|
| Primary | 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) | Posted | Mean | Standard Deviation | score on a scale | Pre-treatment (Day 1) |
|
|
|
| Secondary | Severity of Symptoms of Insomnia - Post Treatment | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity) | Posted | Mean | Standard Deviation | score on a scale | Post-treatment (~6 week after Screening) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | score on a scale | 1-year follow-up (58 week after screening) |
|
|
|
| 946 |
| 0 |
| 946 |
| 0 |
| 946 |
| EG001 | Sleep Education | Weekly email messages with sleep hygiene recommendations Sleep Education | 0 | 439 | 0 | 439 | 0 | 439 |
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |