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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • University of Tulsa

    Tulsa, Oklahoma, 74104

Other trials in United States

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 groups in NCT02236390
Study groupRoleWhat they receive
Cognitive Processing Therapy-CognitiveActive comparator12 sessions of cognitive processing therapy-Cognitive
Receives: Behavioral: Cognitive Processing Therapy - Cognitive
ERRT + CPT-CActive comparator5 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 + ERRTActive comparator12 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.

  1. 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)
  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.

  1. First posted10 Sep 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionNov 2024
  4. Study completionNov 2024

Resources

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)
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

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.

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