Sleep to Prevent Evolving Affecting Disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia, Primary
- Sponsor
- Henry Ford Health System
- Enrollment
- 1385
- Locations
- 1
- Primary Endpoint
- Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)]
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Christopher Drake
Director of Sleep Research
Henry Ford Health System
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)
Outcomes
Primary Outcomes
Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)]
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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))