SAGE: Sleep and Girls' Emotions Study

Sponsor

University of Oregon (Other)

Overall Status

Completed

CT.gov ID

NCT04131868

Collaborator

(none)

Enrollment

Location

Arms

16.5

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Typical sleep opportunity Behavioral: Extended sleep opportunity	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

34 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Feb 19, 2018

Actual Primary Completion Date :

Apr 25, 2019

Actual Study Completion Date :

Jul 7, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
Reward-related brain function [1 week]
BOLD fMRI response during Reward Guessing Task
Sleep duration [1 week]
Mean actigraphy-measured sleep duration

Secondary Outcome Measures

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 effort [1 week]
Effort Expenditure for Rewards Task score
Reward-related functional connectivity [1 week]
BOLD fMRI psychophysiological striatal-medial prefrontal cortex interaction

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 22 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Oregon	Eugene	Oregon	United States	97403

Sponsors and Collaborators

University of Oregon

Investigators

Principal Investigator: Melynda D Casement, PhD, University of Oregon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Melynda Casement, Assistant Professor, University of Oregon

ClinicalTrials.gov Identifier:

NCT04131868

Other Study ID Numbers:

K01MH103511

First Posted:

Oct 18, 2019

Last Update Posted:

Nov 5, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Nov 5, 2019