Post-traumatic Stress Disorder
Conditions
Keywords
Imagery, Nightmares, Post-Traumatic Stress Disorder, Psychotherapy
Brief summary
The purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with Post-traumatic Stress Disorder.
Detailed description
Repetitive, stereotypical nightmares and insomnia commonly characterize post-traumatic stress disorder (PTSD). Identifying the pathophysiological mechanisms of disrupted sleep in PTSD has therefore assumed considerable clinical importance. We previously reported an increase in rapid eye movement activity (REM activity) during REM sleep (REMS) in Vietnam War combat veterans with PTSD, and this finding can be seen as consistent with the view that most, although not all, dreaming occurs during REMS and the repeated observation that REM activity correlates with the intensity of dream mentation. There is a growing body of evidence that post-traumatic nightmares can respond to psychological treatment interventions. Namely, a cognitive-behavioral technique entitled imagery rehearsal (IR) has been reported to be effective in the treatment of such nightmares in victims of crime and in women who have been sexually assaulted. In a small pilot study, it has also been reported to be effective in the treatment of Vietnam veterans with combat-related PTSD. The two objectives of this proposal are: 1. To compare, in a study with random assignment and a parallel group design, the effectiveness in controlling the subjective sleep disturbance in veterans with PTSD of IR and Sleep and Nightmare Management (SN), a psychological treatment that targets life stressors and problems with sleep hygiene that may exacerbate insomnia and nightmares. 2. In a subset of these subjects, to compare the effectiveness in reducing REM activity of IR and SN.
Interventions
BEHAVIORALImagery Rehearsal
IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime.
BEHAVIORALSleep and Nightmare Management
This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Male * Vietnam Combat Veteran * Diagnosis of combat-related PTSD * Stable psychotropic regimen for a minimum of three months * Experiences recurrent nightmares
Exclusion criteria
* Bipolar disorder, delirium, dementia, amnestic and other cognitive disorders * Schizophrenia and other psychotic disorders * Substance abuse or dependence within the last six months * Untreated medical disorders known to impact sleep
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Number of Nightmares | Baseline and 1, 3, and 6 months post-treatment | — |
| Weekly Nights With a Nightmare | Baseline and 1, 3, and 6 months post-treatment | — |
| Pittsburgh Sleep Quality Index | Baseline and 1, 3, and 6 months post-treatment | Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory | Baseline and 1, 3, and 6 months post-treatment | Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression. |
| SF-36 Physical Component | Baseline and 1, 3, and 6 months post-treatment | The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best). |
| Pittsburgh Sleep Quality Index - Addendum | Baseline and 1, 3, and 6 months post-treatment | The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems. |
| Clinician-Administered PTSD Scale (CAPS) | Baseline and 1 month post-treatment | Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms. |
| SF-36 Mental Component | Baseline and 1, 3, and 6 months post-treatment | The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best). |
| Nightmare Effects Survey | Baseline and 1, 3, and 6 months post-treatment | This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment. |
| PTSD Military Checklist | Baseline and 1, 3, and 6 months post-treatment | Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity. |
Countries
United States
Participant flow
Pre-assignment details
Ten participants dropped out prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Imagery Rehearsal Therapy Imagery Rehearsal Therapy
Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime. | 61 |
| Sleep and Nightmare Management Sleep and Nightmare Management
Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets | 63 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lack of Efficacy | 2 | 1 |
| Overall Study | Withdrawal by Subject | 17 | 9 |
Baseline characteristics
| Characteristic | Imagery Rehearsal Therapy | Sleep and Nightmare Management | Total |
|---|---|---|---|
| Age, Continuous | 59.79 years STANDARD_DEVIATION 3.18 | 59.06 years STANDARD_DEVIATION 3.86 | 59.42 years STANDARD_DEVIATION 3.55 |
| Region of Enrollment United States | 61 participants | 63 participants | 124 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 61 Participants | 63 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 53 | 0 / 58 |
Outcome results
Primary
Pittsburgh Sleep Quality Index
Total scores range from 0 to 21, with higher values indicating poorer sleep quality. A score greater than 5 distinguishes between poor and good sleepers.
Time frame: Baseline and 1, 3, and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagery Rehearsal Therapy | Pittsburgh Sleep Quality Index | Baseline | 13.40 units on a scale | Standard Deviation 3 |
| Imagery Rehearsal Therapy | Pittsburgh Sleep Quality Index | 1 month | 12.09 units on a scale | Standard Deviation 4.26 |
| Imagery Rehearsal Therapy | Pittsburgh Sleep Quality Index | 3 months | 12.57 units on a scale | Standard Deviation 3.83 |
| Imagery Rehearsal Therapy | Pittsburgh Sleep Quality Index | 6 months | 12.06 units on a scale | Standard Deviation 4.09 |
| Sleep and Nightmare Management | Pittsburgh Sleep Quality Index | 6 months | 12.00 units on a scale | Standard Deviation 4.51 |
| Sleep and Nightmare Management | Pittsburgh Sleep Quality Index | Baseline | 12.85 units on a scale | Standard Deviation 3.32 |
| Sleep and Nightmare Management | Pittsburgh Sleep Quality Index | 3 months | 11.70 units on a scale | Standard Deviation 3.9 |
| Sleep and Nightmare Management | Pittsburgh Sleep Quality Index | 1 month | 11.82 units on a scale | Standard Deviation 3.79 |
Primary
Weekly Nights With a Nightmare
Time frame: Baseline and 1, 3, and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagery Rehearsal Therapy | Weekly Nights With a Nightmare | Baseline | 2.96 nights/week | Standard Deviation 1.39 |
| Imagery Rehearsal Therapy | Weekly Nights With a Nightmare | 1 month | 2.67 nights/week | Standard Deviation 1.64 |
| Imagery Rehearsal Therapy | Weekly Nights With a Nightmare | 3 months | 3.10 nights/week | Standard Deviation 1.7 |
| Imagery Rehearsal Therapy | Weekly Nights With a Nightmare | 6 months | 2.98 nights/week | Standard Deviation 1.69 |
| Sleep and Nightmare Management | Weekly Nights With a Nightmare | 6 months | 2.68 nights/week | Standard Deviation 1.42 |
| Sleep and Nightmare Management | Weekly Nights With a Nightmare | Baseline | 3.00 nights/week | Standard Deviation 1.43 |
| Sleep and Nightmare Management | Weekly Nights With a Nightmare | 3 months | 2.55 nights/week | Standard Deviation 1.41 |
| Sleep and Nightmare Management | Weekly Nights With a Nightmare | 1 month | 2.78 nights/week | Standard Deviation 1.54 |
Primary
Weekly Number of Nightmares
Time frame: Baseline and 1, 3, and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagery Rehearsal Therapy | Weekly Number of Nightmares | Baseline | 3.95 weekly nightmares | Standard Deviation 2.37 |
| Imagery Rehearsal Therapy | Weekly Number of Nightmares | 1 month | 3.28 weekly nightmares | Standard Deviation 2.47 |
| Imagery Rehearsal Therapy | Weekly Number of Nightmares | 3 months | 3.61 weekly nightmares | Standard Deviation 2.63 |
| Imagery Rehearsal Therapy | Weekly Number of Nightmares | 6 months | 3.20 weekly nightmares | Standard Deviation 2.14 |
| Sleep and Nightmare Management | Weekly Number of Nightmares | 6 months | 3.04 weekly nightmares | Standard Deviation 1.89 |
| Sleep and Nightmare Management | Weekly Number of Nightmares | Baseline | 3.88 weekly nightmares | Standard Deviation 3.95 |
| Sleep and Nightmare Management | Weekly Number of Nightmares | 3 months | 3.09 weekly nightmares | Standard Deviation 2.08 |
| Sleep and Nightmare Management | Weekly Number of Nightmares | 1 month | 3.47 weekly nightmares | Standard Deviation 2.72 |
Secondary
Beck Depression Inventory
Twenty-one items are rated on a 4-point scale. Total scores range from zero to 63, with higher scores indicating more severe depression.
Time frame: Baseline and 1, 3, and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagery Rehearsal Therapy | Beck Depression Inventory | Baseline | 26.85 units on a scale | Standard Deviation 11.82 |
| Imagery Rehearsal Therapy | Beck Depression Inventory | 1 month post-treatment | 24.16 units on a scale | Standard Deviation 13.35 |
| Imagery Rehearsal Therapy | Beck Depression Inventory | 3 months post-treatment | 24.80 units on a scale | Standard Deviation 13.14 |
| Imagery Rehearsal Therapy | Beck Depression Inventory | 6 months post-treatment | 25.02 units on a scale | Standard Deviation 13.3 |
| Sleep and Nightmare Management | Beck Depression Inventory | 6 months post-treatment | 23.37 units on a scale | Standard Deviation 12.34 |
| Sleep and Nightmare Management | Beck Depression Inventory | Baseline | 23.51 units on a scale | Standard Deviation 11.92 |
| Sleep and Nightmare Management | Beck Depression Inventory | 3 months post-treatment | 23.76 units on a scale | Standard Deviation 12.76 |
| Sleep and Nightmare Management | Beck Depression Inventory | 1 month post-treatment | 22.31 units on a scale | Standard Deviation 12.76 |
Secondary
Clinician-Administered PTSD Scale (CAPS)
Seventeen questions assess the frequency and intensity of PTSD symptoms. Scores range from zero to 136, with a higher score indicating more severe symptoms.
Time frame: Baseline and 1 month post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagery Rehearsal Therapy | Clinician-Administered PTSD Scale (CAPS) | Baseline | 81.34 units on a scale | Standard Deviation 14 |
| Imagery Rehearsal Therapy | Clinician-Administered PTSD Scale (CAPS) | 1 month post-treatment | 74.04 units on a scale | Standard Deviation 20.36 |
| Sleep and Nightmare Management | Clinician-Administered PTSD Scale (CAPS) | Baseline | 79.48 units on a scale | Standard Deviation 15.27 |
| Sleep and Nightmare Management | Clinician-Administered PTSD Scale (CAPS) | 1 month post-treatment | 74.85 units on a scale | Standard Deviation 19.52 |
Secondary
Nightmare Effects Survey
This self-report questionnaire assesses psychosocial impairment attributed to nightmares. Eleven self-report questions are rated on a scale of zero to four. The individual scores are summed to produce a total score ranging from 0 to 44 (reported in the Table). Higher scores reflect greater impairment.
Time frame: Baseline and 1, 3, and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagery Rehearsal Therapy | Nightmare Effects Survey | Baseline | 26.39 units on a scale | Standard Deviation 9 |
| Imagery Rehearsal Therapy | Nightmare Effects Survey | 1 month post-treatment | 24.12 units on a scale | Standard Deviation 10.43 |
| Imagery Rehearsal Therapy | Nightmare Effects Survey | 3 months post-treatment | 25.28 units on a scale | Standard Deviation 10.06 |
| Imagery Rehearsal Therapy | Nightmare Effects Survey | 6 months post-treatment | 25.88 units on a scale | Standard Deviation 9.75 |
| Sleep and Nightmare Management | Nightmare Effects Survey | 6 months post-treatment | 24.98 units on a scale | Standard Deviation 10.14 |
| Sleep and Nightmare Management | Nightmare Effects Survey | Baseline | 24.11 units on a scale | Standard Deviation 9.99 |
| Sleep and Nightmare Management | Nightmare Effects Survey | 3 months post-treatment | 24.02 units on a scale | Standard Deviation 10.22 |
| Sleep and Nightmare Management | Nightmare Effects Survey | 1 month post-treatment | 24.66 units on a scale | Standard Deviation 9.18 |
Secondary
Pittsburgh Sleep Quality Index - Addendum
The PSQI-A is a measure of PTSD-related sleep and dream disturbances. Scores can range from 0 to 21, with higher scores reflecting greater sleep problems.
Time frame: Baseline and 1, 3, and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagery Rehearsal Therapy | Pittsburgh Sleep Quality Index - Addendum | Baseline | 17.51 units on a scale | Standard Deviation 4.96 |
| Imagery Rehearsal Therapy | Pittsburgh Sleep Quality Index - Addendum | 1 month post-treatment | 16.71 units on a scale | Standard Deviation 5.18 |
| Imagery Rehearsal Therapy | Pittsburgh Sleep Quality Index - Addendum | 3 months post-treatment | 16.58 units on a scale | Standard Deviation 5.56 |
| Imagery Rehearsal Therapy | Pittsburgh Sleep Quality Index - Addendum | 6 months post-treatment | 17.35 units on a scale | Standard Deviation 5.13 |
| Sleep and Nightmare Management | Pittsburgh Sleep Quality Index - Addendum | 6 months post-treatment | 17.26 units on a scale | Standard Deviation 4.56 |
| Sleep and Nightmare Management | Pittsburgh Sleep Quality Index - Addendum | Baseline | 17.01 units on a scale | Standard Deviation 3.76 |
| Sleep and Nightmare Management | Pittsburgh Sleep Quality Index - Addendum | 3 months post-treatment | 16.36 units on a scale | Standard Deviation 4.16 |
| Sleep and Nightmare Management | Pittsburgh Sleep Quality Index - Addendum | 1 month post-treatment | 16.29 units on a scale | Standard Deviation 3.91 |
Secondary
PTSD Military Checklist
Seventeen items indicating the 17 DSM-IV criteria for PTSD are rated on a 5-point scale, from 1 to 5. Scores range from 17 to 85, with a higher score indicating greater symptom severity.
Time frame: Baseline and 1, 3, and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagery Rehearsal Therapy | PTSD Military Checklist | Baseline | 62.73 units on a scale | Standard Deviation 10.18 |
| Imagery Rehearsal Therapy | PTSD Military Checklist | 1 month post-treatment | 58.83 units on a scale | Standard Deviation 13.56 |
| Imagery Rehearsal Therapy | PTSD Military Checklist | 3 months post-treatment | 60.13 units on a scale | Standard Deviation 12.16 |
| Imagery Rehearsal Therapy | PTSD Military Checklist | 6 months post-treatment | 59.05 units on a scale | Standard Deviation 11.87 |
| Sleep and Nightmare Management | PTSD Military Checklist | 6 months post-treatment | 59.64 units on a scale | Standard Deviation 12.3 |
| Sleep and Nightmare Management | PTSD Military Checklist | Baseline | 65.06 units on a scale | Standard Deviation 9.48 |
| Sleep and Nightmare Management | PTSD Military Checklist | 3 months post-treatment | 61.13 units on a scale | Standard Deviation 12 |
| Sleep and Nightmare Management | PTSD Military Checklist | 1 month post-treatment | 60.96 units on a scale | Standard Deviation 11.43 |
Secondary
SF-36 Mental Component
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 5-8 primarily contribute to the mental component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best).
Time frame: Baseline and 1, 3, and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagery Rehearsal Therapy | SF-36 Mental Component | Baseline | 29.69 units on a scale | Standard Deviation 9.08 |
| Imagery Rehearsal Therapy | SF-36 Mental Component | 1 month post-treatment | 32.33 units on a scale | Standard Deviation 10.63 |
| Imagery Rehearsal Therapy | SF-36 Mental Component | 3 months post-treatment | 30.98 units on a scale | Standard Deviation 9.33 |
| Imagery Rehearsal Therapy | SF-36 Mental Component | 6 months post-treatment | 32.15 units on a scale | Standard Deviation 8.99 |
| Sleep and Nightmare Management | SF-36 Mental Component | 6 months post-treatment | 34.78 units on a scale | Standard Deviation 10.87 |
| Sleep and Nightmare Management | SF-36 Mental Component | Baseline | 34.52 units on a scale | Standard Deviation 12.06 |
| Sleep and Nightmare Management | SF-36 Mental Component | 3 months post-treatment | 34.00 units on a scale | Standard Deviation 10.35 |
| Sleep and Nightmare Management | SF-36 Mental Component | 1 month post-treatment | 32.84 units on a scale | Standard Deviation 9.75 |
Secondary
SF-36 Physical Component
The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Scales 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Scores on each scale are summed and averaged (range = 0 worst-100 best).
Time frame: Baseline and 1, 3, and 6 months post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Imagery Rehearsal Therapy | SF-36 Physical Component | Baseline | 37.17 units on a scale | Standard Deviation 9.21 |
| Imagery Rehearsal Therapy | SF-36 Physical Component | 1 month post-treatment | 39.48 units on a scale | Standard Deviation 10.19 |
| Imagery Rehearsal Therapy | SF-36 Physical Component | 3 months post-treatment | 37.72 units on a scale | Standard Deviation 9.57 |
| Imagery Rehearsal Therapy | SF-36 Physical Component | 6 months post-treatment | 35.80 units on a scale | Standard Deviation 9.64 |
| Sleep and Nightmare Management | SF-36 Physical Component | 6 months post-treatment | 37.21 units on a scale | Standard Deviation 11.23 |
| Sleep and Nightmare Management | SF-36 Physical Component | Baseline | 38.53 units on a scale | Standard Deviation 9.64 |
| Sleep and Nightmare Management | SF-36 Physical Component | 3 months post-treatment | 35.96 units on a scale | Standard Deviation 11.97 |
| Sleep and Nightmare Management | SF-36 Physical Component | 1 month post-treatment | 36.84 units on a scale | Standard Deviation 10.34 |