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Completed

NCT Number: NCT04131868

Sleep and Girls' Emotions Study

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–22 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oregon

Eugene, Oregon, 97403, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Typical sleep opportunity

Behavioral

Typical sleep opportunity with consistent sleep timing for 1 week

Extended sleep opportunity

Behavioral

Extended sleep opportunity by 90 min per night with consistent sleep timing for 1 week

Primary outcomes

  1. Depressive symptoms

    Time frame: 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

    Time frame: 1 week

    BOLD fMRI response during Reward Guessing Task

  3. Sleep duration

    Time frame: 1 week

    Mean actigraphy-measured sleep duration

Secondary outcomes

  1. Positive affect

    Time frame: 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

    Time frame: 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

    Time frame: 1 week

    Effort Expenditure for Rewards Task score

  4. Reward-related functional connectivity

    Time frame: 1 week

    BOLD fMRI psychophysiological striatal-medial prefrontal cortex interaction

Sponsors and collaborators

Lead sponsor

University of Oregon

Other

Registry information

Official study title

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

Acronym: SAGE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2019
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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