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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03831412
• Other study ID #: TU1802
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2021
• Source: University of Tulsa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Nightmare
• Sleep Initiation and Maintenance Disorders
• Trauma

Intervention

Behavioral:
• CBT-I
Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.
• ERRT
Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.

Locations

Country	Name	City	State
United States	Lorton Hall	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Tulsa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index	Change in frequency of insomnia symptoms	From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
Primary	Change in Insomnia Severity Index	Change in severity of insomnia symptoms	From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
Primary	Change in Sleep log	Change in frequency of nightmares	From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
Primary	Change in Sleep log	Change in severity of nightmares	From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
Primary	Change in Beck Suicide Scale	Change in severity of suicidal ideation	From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion

External Links

•   Related Info