Sleep to Prevent Evolving Affecting Disorders
SPREAD
1 other identifier
interventional
1,385
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2016
CompletedFirst Submitted
Initial submission to the registry
December 7, 2016
CompletedFirst Posted
Study publicly available on registry
December 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2018
CompletedResults Posted
Study results publicly available
January 12, 2024
CompletedJanuary 12, 2024
January 1, 2024
2.1 years
December 7, 2016
December 16, 2022
January 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
Secondary Outcomes (2)
Severity of Symptoms of Insomnia - Post Treatment
Post-treatment (~6 week after Screening)
Severity of Symptoms of Insomnia - 1 Year Post Treatment
1-year follow-up (58 week after screening)
Study Arms (2)
dCBTI
EXPERIMENTALOnline access to the digital CBTI program Sleepio
Sleep Education
PLACEBO COMPARATORWeekly email messages with sleep hygiene recommendations
Interventions
Eligibility Criteria
You may qualify if:
- Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henry Ford Health Systemlead
- Robert Wood Johnson Foundationcollaborator
Study Sites (1)
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Related Publications (4)
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.
PMID: 35257648DERIVEDCheng 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.
PMID: 34788453DERIVEDCheng 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.
PMID: 33249492DERIVEDCheng 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.
PMID: 31535688DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Christopher Drake
- Organization
- Henry Ford Health
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Drake, PhD
Henry Ford Medical Center - Columbus
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Sleep Research
Study Record Dates
First Submitted
December 7, 2016
First Posted
December 9, 2016
Study Start
March 8, 2016
Primary Completion
April 26, 2018
Study Completion
September 13, 2018
Last Updated
January 12, 2024
Results First Posted
January 12, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share