Clinical trial NCT02988375: Sleep to Prevent Evolving Affecting Disorders
Official title: Sleep to Prevent Evolving Affecting Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia, Primary
Depression
Keywords: insomnia
depression
digital CBTI
online CBTI
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2016-12-09
Enrollment: 1385
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment
timeFrame: Pre-treatment (Day 1)
measure: Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment
timeFrame: Post-treatment (~6 week after Screening)
measure: Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up
timeFrame: 1-year follow-up (58 week after screening)
measure: Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)]
timeFrame: Pre-treatment (Day 1)
Secondary outcomes:
measure: Severity of Symptoms of Insomnia - Post Treatment
timeFrame: Post-treatment (~6 week after Screening)
measure: Severity of Symptoms of Insomnia - 1 Year Post Treatment
timeFrame: 1-year follow-up (58 week after screening)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Medical Center - Columbus
name: Christopher Drake, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.