Efficacy of a Brief Nightmare Treatment for Veterans

NCT01220401 | Completed Results

• 1 other identifier: TU1107
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disorders; PTSD; Suicide

Keywords

Nightmare; PTSD; Posttraumatic stress disorder; Suicide; Exposure Relaxation Rescription Therapy; Sleep

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Beck Depression Inventory

  Baseline, 1 week, 2 months

Study Arms (1)

ERRT-M

EXPERIMENTAL

Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.

Behavioral: exposure, relaxation, and rescription therapy

Interventions

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.)

ERRT-M

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Tulsa: lead

Study Sites (1)

The University of Tulsa

Tulsa, Oklahoma, 74104, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Stress Disorders, Post-Traumatic; Suicide

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Noelle Balliett
• Organization: University of Tulsa

noelle-balliett@utulsa.edu

918-631-3976

Study Officials

• Noelle Balliett, MA

  The University of Tulsa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 13, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 30, 2019
• Results First Posted: August 8, 2014

Record last verified: 2019-04

Locations

US (1)