Status:

COMPLETED

Brief Telehealth CBT-I Intervention in the Context of the COVID-19 Pandemic

Lead Sponsor:

Stanford University

Conditions:

Sleep Disturbance

Insomnia

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this study is to investigate whether an empirically validated treatment for insomnia (CBT-I) administered early in the course of sleep disturbance can prevent insomnia disorder or lesse...

Detailed Description

The COVID-19 Pandemic and the resulting mass home confinement enacted to mitigate disease spread has created an environment of stress and drastic disruption to daily life. Increases in stress, social ...

Eligibility Criteria

Inclusion

  • Age 18 years or older
  • Access to the internet
  • Subjective complaint of sleep disturbance (ISI ≥10) that began after March 1, 2020 or the COVID-19 Pandemic (self-reported during DUKE Interview)
  • Lives in the United States

Exclusion

  • Presence of suicidal ideation representing high risk as measured by the Sheehan-Suicide Tracking Scale (S-STS).
  • Use of medication specifically prescribed for sleep disturbance and unwilling or unable to discontinue more than one week prior to baseline data collection.
  • Current or lifetime history of bipolar disorder or psychosis
  • Current substance abuse or dependence
  • Not able to verbalize understanding of involvement in research and provide written, informed consent
  • Not fluent or literate in English
  • Unstable pharmacotherapy for other mental health disorders
  • Severe impediment to vision, hearing, and/or hand movement, likely to interfere with the ability to complete assessments, or are unable and/or unlikely to follow study protocols
  • Working rotating shift that overlaps with 2400h

Key Trial Info

Start Date :

June 7 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 19 2022

Estimated Enrollment :

49 Patients enrolled

Trial Details

Trial ID

NCT04409743

Start Date

June 7 2020

End Date

April 19 2022

Last Update

June 9 2022

Active Locations (1)

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1

Stanford University

Palo Alto, California, United States, 94304