Sleep and Girls' Emotions Study

Depression Clinical Trial

— SAGE  

Official title:

The Contribution of Stressful Life Events and Insufficient Sleep to Reward-Related Brain Function and Depression in Adolescent Girls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04131868
• Other study ID #: K01MH103511
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: July 7, 2019

Study information

• Verified date: November 2019
• Source: University of Oregon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Typical sleep opportunity
Typical sleep opportunity with consistent sleep timing for 1 week
• Extended sleep opportunity
Extended sleep opportunity by 90 min per night with consistent sleep timing for 1 week

Locations

Country	Name	City	State
United States	University of Oregon	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
University of Oregon

Country where clinical trial is conducted

United States, 

Outcome

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