NightmaresCPTERRTNCT02236390
Integrating Sleep, Nightmare and PTSD Treatments
A study testing Exposure, Relaxation, and Rescripting Therapy and Cognitive Processing Therapy - Cognitive in people with Nightmares and PTSD, run by University of Tulsa at 1 site in United States.
Trial summary
The purpose of the proposed pilot study is to extend previous findings regarding the efficacy of a brief treatment for chronic posttrauma nightmares and sleep problems by integrating this treatment with evidence-based treatment for posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nightmares, PTSD
- What is being tested?
- Exposure, Relaxation, and Rescripting Therapy and Cognitive Processing Therapy - Cognitive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 Years of Age minimal
- Experienced a trauma
- One nightmare per week for past month, minimal
- meet full criteria for PTSD
Who cannot join
- 17 years of age or younger
- acute psychosis
- bipolar disorder
- intellectual disability
- active suicidality
- untreated substance use disorder within past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrating Sleep and PTSD Treatment: Examining the Role of Emotion Regulation
The purpose of the proposed pilot study is to extend previous findings regarding the efficacy of a brief treatment for chronic posttrauma nightmares and sleep problems by integrating this treatment with evidence-based treatment for posttraumatic stress disorder (PTSD). Cognitive processing therapy (CPT) (Resick \& Schnicke, 1996) is a well-established and efficacious evidence-based psychological treatment for PTSD in both civilian and veteran populations (Forbes et al., 2012; Monson et al., 2006; Resick et al., 2008; Resick, Nishith, Weaver, Astin, \& Feuer, 2002). The U.S. Department of Veterans Affairs (VA) includes CPT among the first-line treatments for PTSD (National Center for PTSD, 2012). A modified protocol without the utilization of written exposure (CPT-C) may be more effective than the original protocol. However, despite such promising evidence, individuals who experience chronic nightmares and sleep problems tend to show smaller gains and persistent nightmares following PTSD treatment (Nappi, Drummond, \& Hall, 2012). Given that nightmares are considered the hallmark of PTSD (Ross, Ball, Sullivan, \& Caroff, 1989) and their treatment-resistant nature (Davis \& Wright, 2007), specific psychological treatments have been developed to target sleep disturbances and nightmares.
Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has exhibited strong support in reducing the frequency and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. In addition, significant decreases in PTSD and depression symptoms have been reported following treatment (Davis et al., 2011; Davis \& Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, \& Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis, Rhudy, \& Favorite, 2011).
There is a call to research suggesting the importance of treatment studies which focus on interventions that integrate nightmare and sleep symptom treatment with evidence-based treatment for PTSD (Nappi et al., 2012). In an effort to respond to this call, we propose to tailor ERRT for use in conjunction with CPT, and preliminarily test ERRT's additive effect to CPT in treating PTSD in community outpatients. We hypothesize that ERRT would increase CPT's treatment efficacy by its specific focus on trauma-related nightmares and sleep disturbances. Sleep difficulties are known to increase tension, and reduce one's ability to cope adaptively (Bonn-Miller, Babson, Vujanovic, \& Feldner, 2010; Hofstetter, Lysaker, \& Mayeda, 2005; Nishith, Resick, \& Mueser, 2001). Thus, with improved sleep an individual may have additional personal coping resources for which s/he can use to address the broader trauma issues (Nappi et al., 2012). To test this integration, we will compare ERRT + CPT, CPT + ERRT, and CPT alone.
- Conditions
- Nightmares, PTSD
- Being tested
- Exposure, Relaxation, and Rescripting Therapy, Cognitive Processing Therapy - Cognitive
- Keywords
- Nightmare, PTSD, Sleep, Emotion Regulation, Exposure Relaxation and Rescripting Therapy, Cognitive Processing Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure, Relaxation, and Rescripting TherapyBehavioural
Also called ERRT, IRT
5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms
Cognitive Processing Therapy - CognitiveBehavioural
Also called CPT-C, CPT
12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy-Cognitive | Active comparator | 12 sessions of cognitive processing therapy-Cognitive Receives: Behavioral: Cognitive Processing Therapy - Cognitive |
| ERRT + CPT-C | Active comparator | 5 sessions of Exposure, Relaxation, and Rescripting Therapy, followed by 12 sessions of Cognitive Processing Therapy- Cognitive Receives: Behavioral: Exposure, Relaxation, and Rescripting Therapy; Behavioral: Cognitive Processing Therapy - Cognitive |
| CPT-C + ERRT | Active comparator | 12 sessions of Cognitive Processing Therapy - Cognitive, followed by 5 sessions of Exposure, Relaxation, and Rescripting Therapy Receives: Behavioral: Exposure, Relaxation, and Rescripting Therapy; Behavioral: Cognitive Processing Therapy - Cognitive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nightmare Frequency
A fill-in-the blank question (range = 0-X nightmares) from the Trauma Related Nightmare Survey will be utilized to determine the past week nightmare frequency at baseline, and 3 and 6 months follow-up. Higher values indicate more nightmares.
Measured: up to 6-months follow-up
Secondary outcomes (1)
Clinician Administered PTSD Scale
This semi-structured clinical interview assesses severity of each of 30 items measuring Diagnostic and Statistical Manual (DSM-5) criteria for PTSD on a 5-point scale (0 - 4), (possible range: 0-80). A symptom is considered present if the severity is rated 2 or higher. Total scores are comprised of four factors (reexperiencing, avoidance, cognitive/emotional and hyperarousal)
Measured: Past Month symptoms measured at baseline, and 3 and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2024
- Study completionNov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NightmaresStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tulsa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Davis, University of Tulsa
- Investigators
- Joanne l Davis, PhD, Principal investigator, University of Tulsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236390
- Sponsor's protocol ID
- TU1459R1
- Other IDs
- HR14-127
- Acronym
- CPTERRT
- Status last verified
- Nov 2024
- First submitted
- 8 Sep 2014
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Davis JL, Rhudy JL, Pruiksma KE, Byrd P, Williams AE, McCabe KM, Bartley EJ. Physiological predictors of response to exposure, relaxation, and rescripting therapy for chronic nightmares in a randomized clinical trial. J Clin Sleep Med. 2011 Dec 15;7(6):622-31. doi: 10.5664/jcsm.1466.
PubMed 22171201
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Sleep and PTSD Treatment: Examining the Role of Emotion Regulation
- ClinicalTrials.gov ID
- NCT02236390
- Acronym / sponsor ID
- CPTERRT / TU1459R1
- Conditions
- Nightmares, PTSD
- Keywords
- Nightmare, PTSD, Sleep, Emotion Regulation, Exposure Relaxation and Rescripting Therapy, Cognitive Processing Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of TulsaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2024 (actual)
- Study completion
- Nov 2024 (actual)
- First posted
- 10 Sep 2014 (estimated)
- 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 purpose of the proposed pilot study is to extend previous findings regarding the efficacy of a brief treatment for chronic posttrauma nightmares and sleep problems by integrating this treatment with evidence-based treatment for posttraumatic stress disorder (PTSD). Cognitive processing therapy (CPT) (Resick \& Schnicke, 1996) is a well-established and efficacious evidence-based psychological treatment for PTSD in both civilian and veteran populations (Forbes et al., 2012; Monson et al., 2006; Resick et al., 2008; Resick, Nishith, Weaver, Astin, \& Feuer, 2002). The U.S. Department of Veterans Affairs (VA) includes CPT among the first-line treatments for PTSD (National Center for PTSD, 2012). A modified protocol without the utilization of written exposure (CPT-C) may be more effective than the original protocol. However, despite such promising evidence, individuals who experience chronic nightmares and sleep problems tend to show smaller gains and persistent nightmares following PTSD treatment (Nappi, Drummond, \& Hall, 2012). Given that nightmares are considered the hallmark of PTSD (Ross, Ball, Sullivan, \& Caroff, 1989) and their treatment-resistant nature (Davis \& Wright, 2007), specific psychological treatments have been developed to target sleep disturbances and nightmares.
Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has exhibited strong support in reducing the frequency and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. In addition, significant decreases in PTSD and depression symptoms have been reported following treatment (Davis et al., 2011; Davis \& Wright, 2007; Long et al., 2011; Swanson, Favorite, Horin, \& Arnedt, 2009). ERRT is currently an evidence-level B suggested treatment (Cranston, Davis, Rhudy, \& Favorite, 2011).
There is a call to research suggesting the importance of treatment studies which focus on interventions that integrate nightmare and sleep symptom treatment with evidence-based treatment for PTSD (Nappi et al., 2012). In an effort to respond to this call, we propose to tailor ERRT for use in conjunction with CPT, and preliminarily test ERRT's additive effect to CPT in treating PTSD in community outpatients. We hypothesize that ERRT would increase CPT's treatment efficacy by its specific focus on trauma-related nightmares and sleep disturbances. Sleep difficulties are known to increase tension, and reduce one's ability to cope adaptively (Bonn-Miller, Babson, Vujanovic, \& Feldner, 2010; Hofstetter, Lysaker, \& Mayeda, 2005; Nishith, Resick, \& Mueser, 2001). Thus, with improved sleep an individual may have additional personal coping resources for which s/he can use to address the broader trauma issues (Nappi et al., 2012). To test this integration, we will compare ERRT + CPT, CPT + ERRT, and CPT alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy-Cognitive | Active comparator | Behavioral: Cognitive Processing Therapy - Cognitive12 sessions of cognitive processing therapy-Cognitive |
| ERRT + CPT-C | Active comparator | Behavioral: Exposure, Relaxation, and Rescripting Therapy, Behavioral: Cognitive Processing Therapy - Cognitive5 sessions of Exposure, Relaxation, and Rescripting Therapy, followed by 12 sessions of Cognitive Processing Therapy- Cognitive |
| CPT-C + ERRT | Active comparator | Behavioral: Exposure, Relaxation, and Rescripting Therapy, Behavioral: Cognitive Processing Therapy - Cognitive12 sessions of Cognitive Processing Therapy - Cognitive, followed by 5 sessions of Exposure, Relaxation, and Rescripting Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 Years of Age minimal
- Experienced a trauma
- One nightmare per week for past month, minimal
- meet full criteria for PTSD
Key exclusion criteria (6 listed)
- 17 years of age or younger
- acute psychosis
- bipolar disorder
- intellectual disability
- active suicidality
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 |
|---|---|---|
| Exposure, Relaxation, and Rescripting TherapyAlso: ERRT, IRT5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms | Behavioural | CPT-C + ERRT, ERRT + CPT-C |
| Cognitive Processing Therapy - CognitiveAlso: CPT-C, CPT12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms. | Behavioural | CPT-C + ERRT, Cognitive Processing Therapy-Cognitive, ERRT + CPT-C |
Primary outcome
Nightmare Frequency
Time frame: up to 6-months follow-up
A fill-in-the blank question (range = 0-X nightmares) from the Trauma Related Nightmare Survey will be utilized to determine the past week nightmare frequency at baseline, and 3 and 6 months follow-up. Higher values indicate more nightmares.
1 secondary outcome
Clinician Administered PTSD Scale
Time frame: Past Month symptoms measured at baseline, and 3 and 6 month follow-up
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 22 Nov 2024.
- Background: PubMed 22171201Davis JL, Rhudy JL, Pruiksma KE, Byrd P, Williams AE, McCabe KM, Bartley EJ. Physiological predictors of response to exposure, relaxation, and rescripting therapy for chronic nightmares in a randomized clinical trial. J Clin Sleep Med. 2011 Dec 15;7(6):622-31. doi: 10.5664/jcsm.1466.
- Related InfoLink provided by the sponsor.
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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.
Joanne l Davis, PhD principal investigator
University of Tulsa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure, Relaxation, and Rescripting Therapy and Cognitive Processing Therapy - Cognitive in people with Nightmares and PTSD, 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 4 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 22 Nov 2024. 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?
Nightmare Frequency (time frame: up to 6-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02236390, which also lists 1 linked publication.
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 22 Nov 2024.