Insomnia Clinical Trial
Official title:
An Investigation Of The Effectiveness of a Cognitive Behavioral Group Treatment Addressing Insomnia and Nightmares In Veterans With PTSD
Many combat Veterans suffer from posttraumatic stress disorder (PTSD), an anxiety disorder that develops after an extremely stressful event or events. PTSD is associated with problems falling asleep or staying asleep. Veterans with PTSD also commonly have nightmares from stressful experiences. These symptoms can cause problems in daily life. Behavioral treatments that do not involve taking medication have been shown to help improve problems related to sleep and nightmares. However, very few of these treatments address both sleep problems and nightmares at the same time, even though many people suffer from both problems. The purpose of this study is to examine the effectiveness of a combined treatment for sleep problems and nightmares in Veterans suffering from combat-related PTSD that is presented in a group format. The investigators hypothesize that the completion of this treatment will lead to increases in sleep quality and decreases in the frequency and severity of nightmares as measured by standard questionnaires.
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Must be enrolled in the Michael E. DeBakey VAMC Trauma Recovery Program and qualify for a diagnosis of combat-related PTSD related to service in Vietnam-era conflicts as measured by responses to the Clinician-Administered PTSD Scale (CAPS) and total score = 50 on the Posttraumatic Stress Disorder Checklist Stressor Specific Version (PCL-S) - Have a clinically significant sleep problem as measured by a total score > 5 on the Pittsburgh Sleep Quality Index (PSQI) - Have a repetitive trauma-related nightmare at least once per week on average, as measured by the Nightmare Frequency Questionnaire (NFQ), and which significantly impairs sleep as measured by response = 2 on question 1a of the Nightmare Effects Survey (NES) - Be stable on current regimen of psychotropic medication (i.e., no changes to medications and/or dosages) if applicable - Must sign consent to be audio-recorded as part of the course of the treatment Exclusion Criteria: - Current substance dependence - Planned or ongoing participation in Prolonged Exposure or Cognitive Processing Therapy during treatment participation - Organic psychosis - Bipolar I disorder - Epilepsy - Currently on benzodiazepine or hypnotic medication to treat sleep - Currently take prazosin - Indication of undiagnosed sleep apnea defined as score = .5 across items 1, 5, and 8 of the Multivariable Apnea Risk Index - Uncontrolled sleep apnea |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Michael E. DeBakey VA Medical Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Michael Debakey Veterans Affairs Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pittsburgh Sleep Quality Index, with Addendum for PTSD | Self report measure of sleep quality and degree to which sleep is affected by PTSD. | baseline and 20 weeks | No |
Primary | Nightmare Effects Survey | Self-report assessment of psychosocial impairment resulting from experience of nightmares | baseline and 20 weeks | No |
Primary | Posttraumatic Stress Disorder Checklist- Stressor Specific Version | Self-report measure of Posttraumatic Stress Disorder symptoms. | baseline and 20 weeks | No |
Secondary | Clinician Administered PTSD Scale | Structured Clinical Interview focused on symptoms of Posttraumatic Stress Disorder | baseline and 10 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT05963542 -
Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia
|
N/A | |
Completed |
NCT06339853 -
Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia
|
N/A | |
Recruiting |
NCT04069247 -
Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia
|
N/A | |
Completed |
NCT04493593 -
Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility
|
N/A | |
Recruiting |
NCT05956886 -
Sleep Chatbot Intervention for Emerging Black/African American Adults
|
N/A | |
Recruiting |
NCT06278077 -
Neurexan - a Clinical Trial in Short-Term Insomnia Patients
|
Phase 2 | |
Completed |
NCT04661306 -
The Better Sleep for Supporters With Insomnia Study
|
N/A | |
Recruiting |
NCT06207279 -
Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
|
||
Recruiting |
NCT06006299 -
Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)
|
N/A | |
Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
Completed |
NCT04564807 -
Testing an Online Insomnia Intervention
|
N/A | |
Completed |
NCT03673397 -
The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression
|
N/A | |
Completed |
NCT04035200 -
Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation
|
Phase 2 | |
Active, not recruiting |
NCT05027438 -
Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention
|
N/A | |
Recruiting |
NCT06053840 -
An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia
|
Phase 4 | |
Not yet recruiting |
NCT06348082 -
Project Women's Insomnia Sleep Health Equity Study (WISHES)
|
N/A | |
Not yet recruiting |
NCT06363799 -
Osteopathic Protocol for Insomnia in College Students
|
N/A | |
Not yet recruiting |
NCT06025968 -
Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis
|
N/A | |
Not yet recruiting |
NCT05991492 -
Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application
|
N/A |