Integrating Sleep, Nightmare and PTSD Treatments

NCT ID: NCT02236390

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Nightmares PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Cognitive Processing Therapy-Cognitive

12 sessions of cognitive processing therapy-Cognitive

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy - Cognitive

Intervention Type BEHAVIORAL

12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.

ERRT + CPT-C

5 sessions of Exposure, Relaxation, and Rescripting Therapy, followed by 12 sessions of Cognitive Processing Therapy- Cognitive

Group Type ACTIVE_COMPARATOR

Exposure, Relaxation, and Rescripting Therapy

Intervention Type BEHAVIORAL

5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms

Cognitive Processing Therapy - Cognitive

Intervention Type BEHAVIORAL

12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.

CPT-C + ERRT

12 sessions of Cognitive Processing Therapy - Cognitive, followed by 5 sessions of Exposure, Relaxation, and Rescripting Therapy

Group Type ACTIVE_COMPARATOR

Exposure, Relaxation, and Rescripting Therapy

Intervention Type BEHAVIORAL

5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms

Cognitive Processing Therapy - Cognitive

Intervention Type BEHAVIORAL

12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.

Interventions

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Exposure, Relaxation, and Rescripting Therapy

5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms

Intervention Type BEHAVIORAL

Cognitive Processing Therapy - Cognitive

12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.

Intervention Type BEHAVIORAL

Other Intervention Names

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ERRT IRT CPT-C CPT

Eligibility Criteria

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Inclusion Criteria

* 18 Years of Age minimal
* Experienced a trauma
* One nightmare per week for past month, minimal
* meet full criteria for PTSD

Exclusion Criteria

* 17 years of age or younger
* acute psychosis
* bipolar disorder
* intellectual disability
* active suicidality
* untreated substance use disorder within past 6 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tulsa

OTHER

Sponsor Role lead

Responsible Party

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Joanne Davis

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joanne l Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tulsa

Locations

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University of Tulsa

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22171201 (View on PubMed)

Related Links

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Other Identifiers

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HR14-127

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TU1459R1

Identifier Type: -

Identifier Source: org_study_id

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