Sleep and Girls' Emotions Study

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Typical sleep opportunity; Behavioral: Extended sleep opportunity

• Registration Number: NCT04131868
• Lead Sponsor: University of Oregon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-19
• Primary Completion: 2019-04-25
• Study Completion: 2019-07-07
• Study First Submitted: 2019-10-16
• Study First Submitted QC: 2019-10-16
• Study First Posted: 2019-10-18
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-02
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Typical sleep opportunity	Typical sleep opportunity	-
Extended sleep opportunity	Extended sleep opportunity	-

Primary Outcome Measures

Name	Time	Method
Reward-related brain function	1 week	BOLD fMRI response during Reward Guessing Task
Sleep duration	1 week	Mean actigraphy-measured sleep duration
Depressive symptoms	1 week	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.

Secondary Outcome Measures

Name	Time	Method
Reward effort	1 week	Effort Expenditure for Rewards Task score
Positive affect	1 week	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.
Negative affect	1 week	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.
Reward-related functional connectivity	1 week	BOLD fMRI psychophysiological striatal-medial prefrontal cortex interaction

Trial Locations

Locations (1)

University of Oregon; 🇺🇸 Eugene, Oregon, United States