Treating Co-Morbid Sleep Difficulties in Veterans With Posttraumatic Stress Disorder (PTSD): A Pilot Study
Study Details
Study Description
Brief Summary
A substantial number of US Veterans are suffering from Posttraumatic Stress Disorder (PTSD) following deployment in recent military conflicts, and sleep disturbance is a primary complaint of Veterans presenting to the VA with PTSD. Veterans with PTSD have more self-reported and physician-rated health problems, and health status is associated with PTSD symptom severity. Most Veterans meeting criteria for PTSD report difficulty initiating or maintaining sleep (70-91%), and increased PTSD severity is associated with increased sleep disturbance. Even after receiving treatment for PTSD, Veterans continue to experience residual insomnia at a rate of about 50%, in spite of having achieved PTSD remission.
There are currently no PTSD-specific sleep interventions available, excepting an intervention that is specific to nightmares. Given the prevalence of sleep disturbance in Veterans with PTSD, the absence of interventions for PTSD-related sleep problems, and the increasing number of post-deployment Veterans with trauma-related sleep difficulties, such interventions are desperately needed. In this study, we will test the effectiveness of a multi-component cognitive-behavioral sleep intervention for PTSD that targets both nightmares and insomnia for improving the overall sleep experience of Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) Veterans with PTSD who are also receiving usual care. The primary objective is to pilot test the intervention for efficacy in reducing sleep disturbance. The secondary objective is to examine the relative impact of the intervention on PTSD symptoms. The project is a prospective, randomized, clinical intervention trial. Participants will be randomly assigned to a multi-component cognitive-behavioral sleep intervention for PTSD + Usual Care, or Usual Care alone. We are hypothesizing that 1) Veterans receiving the sleep intervention plus usual care will produce greater improvements (reduced total wake time, increased sleep efficiency, etc) in subjective sleep measures than will Usual Care alone; 2) Veterans receiving the sleep intervention plus usual care will produce greater improvements in nightmare frequency and severity than will Usual Care alone; and 3) the relationship between PTSD symptoms and treatment group will be significantly related to sleep quality in the period intervening baseline and follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: 2 Usual Care/Wait-List Control |
|
| Experimental: 1 Sleep Intervention for PTSD (SIP) |
Behavioral: Sleep Intervention for PTSD (SIP).
Patients in the SIP condition will receive the same elements as the Usual Care patients. In addition, these patients will receive six, bi-weekly, 1-hour individual sessions with the PI, including 3 sessions of Cognitive-Behavioral Therapy for Insomnia (CBT-I) and 3 sessions of Imagery Rehearsal Therapy (IRT). CBT-I consists of education designed to correct unrealistic sleep expectations, a prescription for an individually-tailored behavioral regimen, standard sleep hygiene recommendations, and the identification and restructuring of dysfunctional beliefs and attitudes regarding sleep. IRT is a brief intervention designed to facilitate the patient's "rescripting" of reoccurring nightmares to decrease their associated affective distress.
|
Outcome Measures
Primary Outcome Measures
- Insomnia Severity [12-weeks after Baseline]
Insomnia severity was assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire that provides a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale, and the total score ranges from 0-28. The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). The ISI was used to determine treatment eligibility, to assess treatment outcome, and to determine clinical significance of study findings. Participants were assessed at baseline and following a 12-week intervention period.
Secondary Outcome Measures
- Nightmare Frequency [12 weeks after Baseline]
Nightmare frequency was assessed using an electronic sleep diary. Diary data was collected for a period of 1 week at both baseline and 12 weeks after baseline. The number and severity of nightmares over a 1-week period were obtained using a hand-held computer (PDA) containing an interactive program that automates the collection of subjective sleep data. The PDA device was programmed to elicit daily responses from participants and electronically record multiple days of subjective sleep information, in addition to the number and severity of nightmares for the previous night. Nightmare frequency (number of nightmares per night) was one of five variables collected from electronic sleep diaries.
Eligibility Criteria
Criteria
Inclusion Criteria: Participants will be recruited from the population of Operation Iraqi Freedom/Operation Enduring Freedom veterans referred to the Posttraumatic Stress Disorder (PTSD) clinic for evaluation and treatment, and volunteers participating in the Mental Illness Research, Education and Clinical Centers (MIRECC) registry who agreed to be recontacted for future studies. All study participants will have: 1) provided informed consent; 2) utilize Durham VA Medical Center health care services as their primary source of health care; 3) will meet the Diagnostic and Statistical Manual (DSM-IV-R) criteria for a diagnosis of PTSD; 4) will screen positive for an Insomnia Disorder on the Duke Structured Sleep Interview for Sleep Disorders (DSISD); 5) and will score greater than 14 on the Insomnia Severity Index (ISI).
Exclusion Criteria: Patients who screen positive on the DSISD for symptoms of Sleep Apnea, Narcolepsy, Restless Legs Syndrome or Circadian Disorders will be excluded from the study. Participants with active drug or alcohol abuse or dependence will be excluded as well.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Durham VA Medical Center | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- Durham VA Medical Center
Investigators
- Principal Investigator: Christi S Ulmer, PhD, Durham VAMC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMR01252
Study Results
Participant Flow
| Recruitment Details | Study participants were recruited between 1/1/2008 and 12/31/2009 using flyers placed throughout the VA hospital and a community Veteran Center, and through letters sent to recently deployed veterans who had enrolled in a VA research registry and who had agreed to be recontacted for participation in VA research. |
|---|---|
| Pre-assignment Detail | Of the 93 self-referred prospective study participants, 22 individuals (15 men and 7 women) met study selection criteria, completed baseline procedures, and were subsequently randomized to treatment conditions. |
| Arm/Group Title | Wait List | Intervention |
|---|---|---|
| Arm/Group Description | Usual Care/Wait-List Control | Sleep Intervention for PTSD (SIP) |
| Period Title: Overall Study | ||
| STARTED | 9 | 13 |
| COMPLETED | 9 | 9 |
| NOT COMPLETED | 0 | 4 |
Baseline Characteristics
| Arm/Group Title | Wait List | Intervention | Total |
|---|---|---|---|
| Arm/Group Description | Usual Care/Wait-List Control | Sleep Intervention for PTSD (SIP) | Total of all reporting groups |
| Overall Participants | 9 | 13 | 22 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
8
88.9%
|
13
100%
|
21
95.5%
|
| >=65 years |
1
11.1%
|
0
0%
|
1
4.5%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
50.22
(11.62)
|
47.00
(9.47)
|
48.61
(10.42)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
4
44.4%
|
3
23.1%
|
7
31.8%
|
| Male |
5
55.6%
|
10
76.9%
|
15
68.2%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
9
100%
|
13
100%
|
22
100%
|
| Insomnia Severity (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
22.00
(3.97)
|
22.77
(4.57)
|
22.46
(4.25)
|
| Sleep Quality (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
14.33
(3.35)
|
14.17
(3.27)
|
14.24
(3.22)
|
| PTSD Symptom Checklist-M (scores on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [scores on a scale] |
63.44
(11.66)
|
63.08
(12.47)
|
63.23
(11.86)
|
| Depression (scores on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [scores on a scale] |
3.88
(2.08)
|
3.77
(1.74)
|
3.82
(1.84)
|
| Sleep-Specific PTSD Symptoms (scores on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [scores on a scale] |
10.00
(5.29)
|
10.00
(4.10)
|
10.00
(4.50)
|
| Nightmare Frequency (Number of nightmares per night) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Number of nightmares per night] |
0.59
(0.68)
|
0.72
(0.43)
|
0.67
(0.53)
|
Outcome Measures
| Title | Insomnia Severity |
|---|---|
| Description | Insomnia severity was assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item questionnaire that provides a global measure of perceived insomnia severity. Each item is rated on a 5-point Likert scale, and the total score ranges from 0-28. The following guidelines are recommended for interpreting the total score: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). The ISI was used to determine treatment eligibility, to assess treatment outcome, and to determine clinical significance of study findings. Participants were assessed at baseline and following a 12-week intervention period. |
| Time Frame | 12-weeks after Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat and completed were both reported. Data on completers reported here. |
| Arm/Group Title | Wait List | Intervention |
|---|---|---|
| Arm/Group Description | Usual Care/Wait-List Control | Sleep Intervention for PTSD (SIP) |
| Measure Participants | 9 | 9 |
| Mean (Standard Error) [ISI Score] |
21.58
(1.90)
|
12.45
(1.90)
|
| Title | Nightmare Frequency |
|---|---|
| Description | Nightmare frequency was assessed using an electronic sleep diary. Diary data was collected for a period of 1 week at both baseline and 12 weeks after baseline. The number and severity of nightmares over a 1-week period were obtained using a hand-held computer (PDA) containing an interactive program that automates the collection of subjective sleep data. The PDA device was programmed to elicit daily responses from participants and electronically record multiple days of subjective sleep information, in addition to the number and severity of nightmares for the previous night. Nightmare frequency (number of nightmares per night) was one of five variables collected from electronic sleep diaries. |
| Time Frame | 12 weeks after Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Wait List | Intervention |
|---|---|---|
| Arm/Group Description | Usual Care/Wait-List Control | Sleep Intervention for PTSD (SIP) |
| Measure Participants | 9 | 9 |
| Mean (Standard Error) [Nightmare frequency per night] |
0.83
(0.17)
|
0.51
(0.18)
|
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Wait List | Intervention | ||
| Arm/Group Description | Usual Care/Wait-List Control | Sleep Intervention for PTSD (SIP) | ||
All Cause Mortality |
||||
| Wait List | Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Wait List | Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/13 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Wait List | Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/9 (0%) | 0/13 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Christi S. Ulmer, PhD |
|---|---|
| Organization | Durham VAMC |
| Phone | 9192860411 ext 4044 |
| christi.ulmer@va.gov |
- IMR01252