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OpenTrials
Completed

NCT Number: NCT03831412

Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy

The objective of this project is to determine if directly addressing disturbed sleep and nightmares will impact client reports of suicidal ideation.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Nightmare Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Trauma Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lorton Hall

Tulsa, Oklahoma, 74104, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • experiences at least one nightmare per week for the past month
  • having previously experienced a traumatic event
  • difficulty falling or staying asleep
  • suicidal ideation
  • actively under the care of another health care provider

Exclusion criteria

  • untreated obstructive sleep apnea
  • acute or apparent psychosis
  • untreated or unstable bipolar disorder
  • past history of seizure disorder or neurological disorder
  • intellectual disability
  • current substance dependence or in past 6 months

Treatment and study plan

CBT-I

Behavioral

Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.

Other names: Cognitive Behavioral Therapy for Insomnia

ERRT

Behavioral

Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.

Other names: Exposure, Relaxation, Rescripting Therapy

Primary outcomes

  1. Change in Insomnia Severity Index

    Time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion

    Change in frequency of insomnia symptoms

  2. Change in Insomnia Severity Index

    Time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion

    Change in severity of insomnia symptoms

  3. Change in Sleep log

    Time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion

    Change in frequency of nightmares

  4. Change in Sleep log

    Time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion

    Change in severity of nightmares

  5. Change in Beck Suicide Scale

    Time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion

    Change in severity of suicidal ideation

Sponsors and collaborators

Lead sponsor

University of Tulsa

Other

Registry information

Official study title

CBT-I Versus ERRT: Impact on Sleep, Nightmares, and Suicidal Ideation

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2019
Registry last updated
Apr 27, 2021

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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