Sleep to Prevent Evolving Affecting Disorders
- Conditions
- Insomnia, PrimaryDepression
- Interventions
- Behavioral: dCBTIBehavioral: 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
- Meets Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition(DSMV) criteria for insomnia
- 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
Group Intervention Description dCBTI dCBTI Online access to the digital CBTI program Sleepio Sleep Education Sleep Education Weekly email messages with sleep hygiene recommendations
- Primary Outcome Measures
Name Time Method 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-Treatment 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), 1-year Follow-up 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 Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment 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)
- Secondary Outcome Measures
Name Time Method Severity of Symptoms of Insomnia - Post Treatment Post-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 Treatment 1-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