Sleep and Girls' Emotions Study (SAGE)

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Extended sleep opportunity; Behavioral: Typical sleep opportunity

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97403
      • University of Oregon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 22 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Extended sleep opportunity	Behavioral: Extended sleep opportunity; Extended sleep opportunity by 90 min per night with consistent sleep timing for 1 week
ACTIVE_COMPARATOR: Typical sleep opportunity	Behavioral: Typical sleep opportunity; Typical sleep opportunity with consistent sleep timing for 1 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Reward-related brain function	BOLD fMRI response during Reward Guessing Task	1 week
Sleep duration	Mean actigraphy-measured sleep duration	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Reward effort	Effort Expenditure for Rewards Task score	1 week
Reward-related functional connectivity	BOLD fMRI psychophysiological striatal-medial prefrontal cortex interaction	1 week

Collaborators and Investigators

• Sponsor: University of Oregon

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 19, 2018
• Primary Completion (ACTUAL): April 25, 2019
• Study Completion (ACTUAL): July 7, 2019

Study Registration Dates

• First Submitted: October 16, 2019
• First Submitted That Met QC Criteria: October 16, 2019
• First Posted (ACTUAL): October 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 2, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: K01MH103511 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No