N/A
N=1,385
Sleep to Prevent Evolving Affecting Disorders
Insomnia, Primary · Depression
Bottom Line
View on ClinicalTrials.gov: NCT02988375 ↗Enrolled (actual)
1,385
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment — 10.8; 10.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- dCBTI (Behavioral); Sleep Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Henry Ford Health System
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Pre-Treatment |
10.8; 10.8 | — |
| PRIMARY Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS) Post-Treatment |
3.9; 6.4 | — |
| PRIMARY Severity of Depression as Measured by the Quick Inventory of Depressive Symptomatology (QIDS), 1-year Follow-up |
4.7; 6.5 | — |
| PRIMARY Severity of Symptoms of Insomnia [Time Frame: Pre-treatment (Day 1)] |
17.8; 17.7 | — |
| SECONDARY Severity of Symptoms of Insomnia - Post Treatment |
17.9; 17.7 | — |
| SECONDARY Severity of Symptoms of Insomnia - 1 Year Post Treatment |
8.2; 12.8 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT02988375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.