Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy
CBT-I Versus ERRT: Impact on Sleep, Nightmares, and Suicidal Ideation
1 other identifier
interventional
13
1 country
1
Brief Summary
The objective of this project is to determine if directly addressing disturbed sleep and nightmares will impact client reports of suicidal ideation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 27, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedApril 27, 2021
April 1, 2021
3.5 years
October 27, 2018
April 26, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
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
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
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
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
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
Study Arms (2)
CBT-I
ACTIVE COMPARATOR5 sessions of treating insomnia
ERRT
ACTIVE COMPARATOR5 sessions of treating post-trauma nightmares
Interventions
Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.
Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lorton Hall
Tulsa, Oklahoma, 74104, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 27, 2018
First Posted
February 5, 2019
Study Start
August 1, 2017
Primary Completion
January 31, 2021
Study Completion
January 31, 2021
Last Updated
April 27, 2021
Record last verified: 2021-04