InsomniaNCT03831412
Cognitive Behavioral Therapy for Insomnia vs. Exposure, Relaxation, and Rescripting Therapy
A study testing CBT-I and ERRT in people with Insomnia and Nightmare, run by University of Tulsa at 1 site in United States.
Trial summary
The objective of this project is to determine if directly addressing disturbed sleep and nightmares will impact client reports of suicidal ideation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- What is being tested?
- CBT-I and ERRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- CBT-I, ERRT
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
Also called Cognitive Behavioral Therapy for Insomnia
Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.
ERRTBehavioural
Also called Exposure, Relaxation, Rescripting Therapy
Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Active comparator | 5 sessions of treating insomnia Receives: Behavioral: CBT-I |
| ERRT | Active comparator | 5 sessions of treating post-trauma nightmares Receives: Behavioral: ERRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index
Change in frequency of insomnia symptoms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Aug 2017
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tulsa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Davis, University of Tulsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831412
- Sponsor's protocol ID
- TU1802
- Status last verified
- Apr 2021
- First submitted
- 27 Oct 2018
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT-I Versus ERRT: Impact on Sleep, Nightmares, and Suicidal Ideation
- ClinicalTrials.gov ID
- NCT03831412
- Acronym / sponsor ID
- TU1802
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of TulsaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to determine if directly addressing disturbed sleep and nightmares will impact client reports of suicidal ideation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Active comparator | Behavioral: CBT-I5 sessions of treating insomnia |
| ERRT | Active comparator | Behavioral: ERRT5 sessions of treating post-trauma nightmares |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- untreated obstructive sleep apnea
- acute or apparent psychosis
- untreated or unstable bipolar disorder
- past history of seizure disorder or neurological disorder
- intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-IAlso: Cognitive Behavioral Therapy for InsomniaTargeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience. | Behavioural | CBT-I |
| ERRTAlso: Exposure, Relaxation, Rescripting TherapyTargeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience. | Behavioural | ERRT |
Primary outcome
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I and ERRT in people with Insomnia and Nightmare, run by University of Tulsa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (time frame: From initial assessment to each session of treatment, and at 3 and 6 months after treatment completion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.