Depression Clinical Trial
— SAGEOfficial title:
The Contribution of Stressful Life Events and Insufficient Sleep to Reward-Related Brain Function and Depression in Adolescent Girls
Verified date | November 2019 |
Source | University of Oregon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates whether increasing sleep duration can increase neural and behavioral response to rewards and decrease depressive symptoms in 18- to 22-year-old women with insufficient sleep and depressive symptoms.
Status | Completed |
Enrollment | 34 |
Est. completion date | July 7, 2019 |
Est. primary completion date | April 25, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 22 Years |
Eligibility |
Inclusion Criteria: - Insufficient sleep (total sleep time < 8 hours per night, with sleepiness scores = 6 on the Epworth Sleepiness Scale OR = 16 on the PROMIS Sleep Related Impairment Scale) - Symptoms of depression (= 15 on the Center for Epidemiological Studies for Depression Scale) Exclusion Criteria: - Current insomnia, hypersomnia, sleep disordered breathing, sleep movement disorder, or circadian rhythm disorder - History of head injury with loss of consciousness within the past two years - History of head injury with loss of consciousness two or more years ago and meet criteria for post concussion syndrome - Neurological disorder - Use of psychiatric medications - Current psychotic symptoms - Active suicidal ideation - Conditions that are contraindicated for MRI (e.g., ferromagnetic material in the body) - Meet criteria for current substance use disorder with greater than mild severity |
Country | Name | City | State |
---|---|---|---|
United States | University of Oregon | Eugene | Oregon |
Lead Sponsor | Collaborator |
---|---|
University of Oregon |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depressive symptoms | Center for Epidemiological Studies Depression Scale score. The CESD-R is a 20-item measure of the frequency of depressive symptoms, with each item rated on a scale from 0 (not at all or less than one day) to 5 (nearly every day). Total scores range from 0 to 100, with higher scores indicating greater number and frequency of depressive symptoms. | 1 week | |
Primary | Reward-related brain function | BOLD fMRI response during Reward Guessing Task | 1 week | |
Primary | Sleep duration | Mean actigraphy-measured sleep duration | 1 week | |
Secondary | Positive affect | International Positive and Negative Affect Scale Short Form - Positive Affect score. The I-PANAS-SF is a 10-item scale that asks participants to rate the extent to which 5 positive and 5 negative adjectives describe them on a scale of 1 (never) to 5 (always). Scores for each positive adjective are summed to produce a Positive Affect (PA) score ranging from 5 to 25, with higher scores indicating more positive affect. | 1 week | |
Secondary | Negative affect | International Positive and Negative Affect Scale Short Form - Negative Affect score. The I-PANAS-SF is a 10-item scale that asks participants to rate the extent to which 5 positive and 5 negative adjectives describe them on a scale of 1 (never) to 5 (always). Scores for each negative adjective are summed to produce a Negative Affect (PA) score ranging from 5 to 25, with higher scores indicating more negative affect. | 1 week | |
Secondary | Reward effort | Effort Expenditure for Rewards Task score | 1 week | |
Secondary | Reward-related functional connectivity | BOLD fMRI psychophysiological striatal-medial prefrontal cortex interaction | 1 week |
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