Efficacy of a Brief Nightmare Treatment for Veterans

PTSD Clinical Trial

Official title:

Efficacy of a Brief Nightmare Treatment for Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220401
• Other study ID #: TU1107
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: April 2019
• Source: University of Tulsa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out what effects Exposure, Rescripting, and Relaxation Therapy (ERRT) has on nightmares and associated problems in veterans.

Description:

The purpose of the proposed pilot study is to extend previous findings regarding the impact of a brief cognitive behavioral treatment for chronic nightmares by examining the emotional, cognitive, behavioral, and health-related changes following treatment. Experiencing a traumatic event may initiate or exacerbate the occurrence of nightmares. Indeed, sleep disturbance, including nightmares, is considered a hallmark of posttraumatic stress disorder (PTSD). Nightmares have been related to a variety of factors including stress, medications, trauma, and substance use. Among veterans, especially combat veterans or those reporting sexual assaults, symptoms of traumatic stress and nightmares are extremely common. Few studies have investigated the efficacy of nightmare treatment in a veteran population, and the impact of nightmare treatment on suicidal ideation has never been assessed.

Imagery Rehearsal Treatment (IRT) has received increased attention in the past decade for use with chronic nightmares. Studies suggest that the treatment is promising for the reduction of frequency and intensity of chronic nightmares in trauma exposed persons and may have a generalized impact on symptoms of posttraumatic stress disorder and depression and quality/quantity of sleep, although there is mixed evidence for sleep improvement among veterans. The principal investigator has completed two randomized controlled trials of a modified version of IRT, Exposure, Rescripting, and Relaxation Treatment (ERRT) and is currently conducting a third randomized controlled trial (Davis, 2008; Davis & Wright, 2007). The current randomized controlled trial is comparing ERRT to an active treatment (relaxation). Results demonstrated positive treatment response. Although these trials have included some veteran participants, veterans have not been studied as a group using this protocol. The purpose of this prospective study is to conduct a pre- and post-treatment comparison of suicidal ideation and posttraumatic, depressive, and health symptoms in a single group of veterans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria: veteran/military, 18+ years old, english proficiency, nightmares once per week, exposure to a criterion A traumatic event -

Exclusion Criteria: under 18, psychotic illness, mental retardation, imminent suicidal intent

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Related Conditions & MeSH terms

• Parasomnias
• PTSD
• Sleep Disorders
• Sleep Wake Disorders
• Suicide

Intervention

Behavioral:
• exposure, relaxation, and rescription therapy
veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)

Locations

Country	Name	City	State
United States	The University of Tulsa	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Tulsa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Nights With Nightmares	This fill-in-the-blank variable assesses the number of nights the individual experienced nightmares in the past week (range = 0 - 7 nights). Higher values indicate more nights with nightmares (worse outcome).	pre, one week, two months
Primary	Clinician Administered PTSD Scale	This semi-structured clinical interview assesses each of 17 DSM-IV-TR criteria for PTSD utilizing separate queries for frequency and severity on a 5-point scale (0 - 4). This study utilized the "FI/I2" rule, where frequency ratings of one or more and intensity ratings of two or more must be present in order for a symptom to count towards diagnosis.; Total scores are comprised of the three factors (reexperiencing, avoidance, and hyperarousal), with 136 being the maximum. 0-19 = asymptomatic or few symptoms. 20-39 = mild PTSD, subthreshold. 40-59 = moderate PTSD at threshold. 60-79 = severe PTSD. 80+ = extreme PTSD.	pre, one week, two months
Primary	Past Week Nightmare Frequency	This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares). Higher values indicate more nightmares (worse outcome).	pre, one week, two months
Secondary	Beck Depression Inventory	This 21-item, self-report measure was designed to assess the severity of depression among adults. Responses on a Likert-type scale range from 0 - 3, and scores may be summed to derive a total score (0-63), with higher scores indicating more depressive symptoms. Scores of 18 and above have been suggested to reliably identify depressed patients.	Baseline, 1 week, 2 months