Depression Clinical Trial
— SPREADOfficial title:
Sleep to Prevent Evolving Affecting Disorders
NCT number | NCT02988375 |
Other study ID # | 10320 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 8, 2016 |
Est. completion date | September 13, 2018 |
Verified date | January 2024 |
Source | Henry Ford Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1385 |
Est. completion date | September 13, 2018 |
Est. primary completion date | April 26, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Hospital | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System | Robert Wood Johnson Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Severity of Symptoms of Insomnia - Post Treatment | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity) | Post-treatment (~6 week after Screening) | |
Secondary | Severity of Symptoms of Insomnia - 1 Year Post Treatment | Insomnia Severity Index Score (ISI; total score range 0-28, with higher scores meaning greater severity) | 1-year follow-up (58 week after screening) |
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