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Sleep to Prevent Evolving Affecting Disorders

Not Applicable
Completed
Conditions
Insomnia, Primary
Depression
Interventions
Behavioral: dCBTI
Behavioral: Sleep Education
Registration Number
NCT02988375
Lead Sponsor
Henry Ford Health System
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1385
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
dCBTIdCBTIOnline access to the digital CBTI program Sleepio
Sleep EducationSleep EducationWeekly email messages with sleep hygiene recommendations
Primary Outcome Measures
NameTimeMethod
Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)]Pre-treatment (Day 1)

Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)

Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-TreatmentPre-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), 1-year Follow-up1-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 Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-TreatmentPost-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)

Secondary Outcome Measures
NameTimeMethod
Severity of Symptoms of Insomnia - Post TreatmentPost-treatment (~6 week after Screening)

Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)

Severity of Symptoms of Insomnia - 1 Year Post Treatment1-year follow-up (58 week after screening)

Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity)

Trial Locations

Locations (1)

Henry Ford Hospital

🇺🇸

Detroit, Michigan, United States

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