SAGE: Sleep and Girls' Emotions Study

Sponsor
University of Oregon (Other)
Overall Status
Completed
CT.gov ID
NCT04131868
Collaborator
(none)
34
Enrollment
1
Location
2
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 DiseaseIntervention/TreatmentPhase
  • 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

ArmIntervention/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

  1. 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.

  2. Reward-related brain function [1 week]

    BOLD fMRI response during Reward Guessing Task

  3. Sleep duration [1 week]

    Mean actigraphy-measured sleep duration

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. Reward effort [1 week]

    Effort Expenditure for Rewards Task score

  4. 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:
No
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

SiteCityStateCountryPostal Code
1University of OregonEugeneOregonUnited States97403

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:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 5, 2019