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Sleep and Girls' Emotions Study (SAGE)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Typical sleep opportunity
Extended sleep opportunity
Sponsored by
University of Oregon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Depression

Eligibility Criteria

18 Years - 22 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • University of Oregon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extended sleep opportunity

Typical sleep opportunity

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2019
Last Updated
November 2, 2019
Sponsor
University of Oregon
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1. Study Identification

Unique Protocol Identification Number
NCT04131868
Brief Title
Sleep and Girls' Emotions Study
Acronym
SAGE
Official Title
The Contribution of Stressful Life Events and Insufficient Sleep to Reward-Related Brain Function and Depression in Adolescent Girls
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
July 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oregon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended sleep opportunity
Arm Type
Experimental
Arm Title
Typical sleep opportunity
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Typical sleep opportunity
Intervention Description
Typical sleep opportunity with consistent sleep timing for 1 week
Intervention Type
Behavioral
Intervention Name(s)
Extended sleep opportunity
Intervention Description
Extended sleep opportunity by 90 min per night with consistent sleep timing for 1 week
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
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.
Time Frame
1 week
Title
Reward-related brain function
Description
BOLD fMRI response during Reward Guessing Task
Time Frame
1 week
Title
Sleep duration
Description
Mean actigraphy-measured sleep duration
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Positive affect
Description
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.
Time Frame
1 week
Title
Negative affect
Description
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.
Time Frame
1 week
Title
Reward effort
Description
Effort Expenditure for Rewards Task score
Time Frame
1 week
Title
Reward-related functional connectivity
Description
BOLD fMRI psychophysiological striatal-medial prefrontal cortex interaction
Time Frame
1 week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melynda D Casement, PhD
Organizational Affiliation
University of Oregon
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Sleep and Girls' Emotions Study

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