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Completed

NCT Number: NCT01220401

Efficacy of a Brief Nightmare Treatment for Veterans

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.

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Key information

Conditions

Sleep Disorders Behavior Behavioral Symptoms Mental Disorders Nervous System Diseases Neurologic Manifestations PTSD Pathological Conditions, Signs and Symptoms Self-Injurious Behavior Signs and Symptoms Sleep Wake Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Suicide Trauma and Stressor Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Tulsa

Tulsa, Oklahoma, 74104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

exposure, relaxation, and rescription therapy

Behavioral

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.)

Primary outcomes

  1. Number of Nights With Nightmares

    Time frame: pre, one week, two months

    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).

  2. Clinician Administered PTSD Scale

    Time frame: pre, one week, two months

    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.

  3. Past Week Nightmare Frequency

    Time frame: pre, one week, two months

    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).

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: Baseline, 1 week, 2 months

    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.

Sponsors and collaborators

Lead sponsor

University of Tulsa

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 13, 2010
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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