PTSD, Sleep Disorders, Suicide
Conditions
Keywords
Nightmare, PTSD, Posttraumatic stress disorder, Suicide, Exposure Relaxation Rescription Therapy, Sleep
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.
Detailed 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.
Interventions
BEHAVIORALexposure, 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.)
Sponsors
University of Tulsa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Nights With Nightmares | 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). |
| Clinician Administered PTSD Scale | 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. |
| Past Week Nightmare Frequency | 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
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ERRT-M Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.
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.) | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | ERRT-M |
|---|---|
| Age, Customized | 56.6 years STANDARD_DEVIATION 12.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
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.
Time frame: pre, one week, two months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ERRT-M | Clinician Administered PTSD Scale | Baseline TOTAL PTSD | 50.72 units on a scale | Standard Deviation 24.6 |
| ERRT-M | Clinician Administered PTSD Scale | 1-week TOTAL PTSD | 46.44 units on a scale | Standard Deviation 27.62 |
| ERRT-M | Clinician Administered PTSD Scale | 2-month TOTAL PTSD | 43.00 units on a scale | Standard Deviation 23.1 |
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).
Time frame: pre, one week, two months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ERRT-M | Number of Nights With Nightmares | Baseline Nights with Nightmares | 2.61 nights/week | Standard Deviation 1.79 |
| ERRT-M | Number of Nights With Nightmares | 1-week Nights with Nightmare | .83 nights/week | Standard Deviation 1.2 |
| ERRT-M | Number of Nights With Nightmares | 2-month Nights with Nightmare | 0.97 nights/week | Standard Deviation 1.23 |
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).
Time frame: pre, one week, two months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ERRT-M | Past Week Nightmare Frequency | Baseline Nightmare Frequency (# in past week) | 2.97 nightmares/week | Standard Deviation 1.78 |
| ERRT-M | Past Week Nightmare Frequency | 1 Week Nightmare Frequency (# in past week) | 1.17 nightmares/week | Standard Deviation 1.48 |
| ERRT-M | Past Week Nightmare Frequency | 2 Month Nightmare Frequency (# in past week) | 1.03 nightmares/week | Standard Deviation 1.3 |
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.
Time frame: Baseline, 1 week, 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ERRT-M | Beck Depression Inventory | Baseline Depression | 27.61 units on a scale | Standard Deviation 11.72 |
| ERRT-M | Beck Depression Inventory | 1-week Depression | 18.94 units on a scale | Standard Deviation 8.9 |
| ERRT-M | Beck Depression Inventory | 2-month Depression | 22.11 units on a scale | Standard Deviation 11.11 |