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

Primary Purpose

Insomnia, Nightmare, Trauma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBT-I

ERRT

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Lorton Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CBT-I

ERRT

Arm Description

5 sessions of treating insomnia

5 sessions of treating post-trauma nightmares

Outcomes

Primary Outcome Measures

Change in Insomnia Severity Index

Change in frequency of insomnia symptoms

Change in Insomnia Severity Index

Change in severity of insomnia symptoms

Change in Sleep log

Change in frequency of nightmares

Change in Sleep log

Change in severity of nightmares

Change in Beck Suicide Scale

Change in severity of suicidal ideation

Secondary Outcome Measures

Full Information

NCT ID

NCT03831412

First Posted

October 27, 2018

Last Updated

April 26, 2021

Sponsor

University of Tulsa

1. Study Identification

Unique Protocol Identification Number

NCT03831412

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

January 31, 2021 (Actual)

Study Completion Date

January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Tulsa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Nightmare, Trauma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT-I

Arm Type

Active Comparator

Arm Description

5 sessions of treating insomnia

Arm Title

ERRT

Arm Type

Active Comparator

Arm Description

5 sessions of treating post-trauma nightmares

Intervention Type

Behavioral

Intervention Name(s)

CBT-I

Other Intervention Name(s)

Cognitive Behavioral Therapy for Insomnia

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

ERRT

Other Intervention Name(s)

Exposure, Relaxation, Rescripting Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Insomnia Severity Index

Description

Change in frequency of insomnia symptoms

Time Frame