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

April 26, 2021 updated by: Joanne Davis, University of Tulsa

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Lorton Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: CBT-I
5 sessions of treating insomnia
Behavioral: CBT-I
Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.
Other Names:
  • Cognitive Behavioral Therapy for Insomnia
ACTIVE_COMPARATOR: ERRT
5 sessions of treating post-trauma nightmares
Behavioral: ERRT
Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.
Other Names:
  • Exposure, Relaxation, Rescripting Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
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
From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
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
From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
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
From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
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
From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tulsa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2017

Primary Completion (ACTUAL)

January 31, 2021

Study Completion (ACTUAL)

January 31, 2021

Study Registration Dates

First Submitted

October 27, 2018

First Submitted That Met QC Criteria

February 4, 2019

First Posted (ACTUAL)

February 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TU1802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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