An interventional study of exposure, relaxation, and rescription therapy in Sleep Disorders, PTSD and Suicide, sponsored by University of Tulsa. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-04-30.
Sponsored by University of Tulsa · Not applicable, Interventional, and Treatment
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.
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.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 21 is below the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →University of Tulsa is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
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.)
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).
Time frame: 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.
Time frame: 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).
Time frame: pre, one week, two months
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.
Time frame: Baseline, 1 week, 2 months
| Milestone | ERRT-M |
|---|---|
| Started | 21 |
| Completed | 18 |
| Not completed | 3 |
| Withdrew: Withdrawal by subject | 2 |
| Withdrew: Protocol violation | 1 |
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).
| nights/week | ERRT-M |
|---|---|
| Baseline Nights with Nightmares | 2.61 ± 1.79 |
| 1-week Nights with Nightmare | .83 ± 1.20 |
| 2-month Nights with Nightmare | 0.97 ± 1.23 |
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.
| units on a scale | ERRT-M |
|---|---|
| Baseline TOTAL PTSD | 50.72 ± 24.60 |
| 1-week TOTAL PTSD | 46.44 ± 27.62 |
| 2-month TOTAL PTSD | 43.00 ± 23.10 |
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.
| units on a scale | ERRT-M |
|---|---|
| Baseline Depression | 27.61 ± 11.72 |
| 1-week Depression | 18.94 ± 8.90 |
| 2-month Depression | 22.11 ± 11.11 |
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).
| nightmares/week | ERRT-M |
|---|---|
| Baseline Nightmare Frequency (# in past week) | 2.97 ± 1.78 |
| 1 Week Nightmare Frequency (# in past week) | 1.17 ± 1.48 |
| 2 Month Nightmare Frequency (# in past week) | 1.03 ± 1.30 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ERRT-M | — | 0/21 (0%) | 0/21 (0%) |
| Age, Customized(years) | ERRT-M |
|---|---|
| Mean | 56.6 ± 12.5 |
| Sex: Female, Male(Participants) | ERRT-M |
|---|---|
| Female | 5 |
| Male | 16 |
| Race (NIH/OMB)(Participants) | ERRT-M |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 14 |
| More than one race | 6 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | ERRT-M |
|---|---|
| United States | 21 |
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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