NCT04131868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

October 16, 2019

Last Update Submit

November 2, 2019

Conditions

Depression

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Positive affect

    1 week

  • Negative affect

    1 week

  • Reward effort

    1 week

  • Reward-related functional connectivity

    1 week

Study Arms (2)

Extended sleep opportunity

EXPERIMENTAL
Behavioral: Extended sleep opportunity

Typical sleep opportunity

ACTIVE COMPARATOR
Behavioral: Typical sleep opportunity

Interventions

Typical sleep opportunityBEHAVIORAL

Typical sleep opportunity with consistent sleep timing for 1 week

Typical sleep opportunity
Extended sleep opportunityBEHAVIORAL

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

Extended sleep opportunity

Eligibility Criteria

Age18 Years - 22 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility is based on self-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oregon

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Melynda D Casement, PhD

    University of Oregon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 18, 2019

Study Start

February 19, 2018

Primary Completion

April 25, 2019

Study Completion

July 7, 2019

Last Updated

November 5, 2019

Record last verified: 2019-11

Locations

US(1)