Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393874
Status:
COMPLETED
Last Update Posted:
2016-10-24
First Post:
2006-10-26
Brief Title:
Efficacy of Sleep Interventions for Posttraumatic Stress Disorder PTSD
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Efficacy of Adjunct Sleep Interventions for PTSD
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASI-P
Brief Summary:
The purpose of this research study is to evaluate and compare the effects of experimental treatments aimed at improving insomnia and nightmares in men and women military veterans between the ages of 18 and 60 years old and who have a condition called Posttraumatic Stress Disorder Insomnia refers to difficulty falling or staying asleep although enough time is allowed for sleeping Insomnia is also associated with daytime consequences such as lack of energy irritability and difficulty concentrating Nightmares are bad dreams that may or may not awaken the sleeper and that cause discomfort during the daytime
Chronic Posttraumatic Stress Disorder PTSD refers to symptoms that occur after someone experienced or witnessed a life-threatening event and that persist for three months or more after the event Symptoms include flashbacks nightmares feelings of detachment from others sleep disturbances irritability anxiety and efforts to avoid people and places associated with the life-threatening event These symptoms occur after a life-threatening event Symptoms that persist for more than one month indicate the presence of PTSD In the present study we will study people with chronic PTSD which refers to PTSD symptoms that persist for more than 3 months
Efficacy of a treatment is defined as the capacity to produce the desired effects In this study we will evaluate and compare the capacity of two active experimental treatments to reduce insomnia and nightmares associated with PTSD and one inactive intervention called a placebo for people who continue to have sleep difficulties despite receiving treatment with an antidepressant medication called a selective serotonin reuptake inhibitor SSRI like Prozac Paxil Zoloft Celexa The two active experimental treatments are a medication prazosin and a brief behavioral intervention which involves exercises and techniques to reduce nightmares and improve sleep quality Prazosin is an approved medication by the Food and Drug Administration FDA against high blood pressure but is not FDA-approved for posttraumatic insomnia and nightmares
Chronic Posttraumatic Stress Disorder PTSD refers to symptoms that occur after someone experienced or witnessed a life-threatening event and that persist for three months or more after the event Symptoms include flashbacks nightmares feelings of detachment from others sleep disturbances irritability anxiety and efforts to avoid people and places associated with the life-threatening event These symptoms occur after a life-threatening event Symptoms that persist for more than one month indicate the presence of PTSD In the present study we will study people with chronic PTSD which refers to PTSD symptoms that persist for more than 3 months
Efficacy of a treatment is defined as the capacity to produce the desired effects In this study we will evaluate and compare the capacity of two active experimental treatments to reduce insomnia and nightmares associated with PTSD and one inactive intervention called a placebo for people who continue to have sleep difficulties despite receiving treatment with an antidepressant medication called a selective serotonin reuptake inhibitor SSRI like Prozac Paxil Zoloft Celexa The two active experimental treatments are a medication prazosin and a brief behavioral intervention which involves exercises and techniques to reduce nightmares and improve sleep quality Prazosin is an approved medication by the Food and Drug Administration FDA against high blood pressure but is not FDA-approved for posttraumatic insomnia and nightmares
Detailed Description:
Posttraumatic stress disorder PTSD is a prevalent disorder in military samples associated with adverse emotional and health impacts and enormous health care costs and it is often resistant to treatment Identification of PTSD-related factors that contribute to poor clinical and health outcomes is imperative to refine treatment strategies Post deployment -related sleep disturbances constitute one of the factors that contribute to poor clinical and health outcomes PTSD symptoms persist during sleep but little clinical attention is typically devoted to nighttime symptoms Other deployment related stress reactions are associated with sleep disturbances Sleep disturbances are resistant to traditional PTSD treatments There is emerging evidence that adjunct sleep-focused interventions pharmacological or behavioral are associated with improvements in sleep daytime symptomatology general emotional well being and functioning Therefore sleep focused interventions may enhance treatment response and clinical outcomes in individuals exposed to trauma with consequent sleep disturbances However the efficacy and durability of adjunct sleep interventions have not been formally evaluated and compared In this study we aim at comparing the efficacy and durability of interventions targeting sleep disturbances that occurred in relation to military service and or military deployment
The overarching objective of this study is to investigate and compare the efficacy and durability of adjunct sleep-focused interventions on sleep daytime PTSD symptomatology and mood in a sample of 90 male and female veterans who experience nightmares and insomnia The specific aims and hypotheses are 1 To investigate the efficacy of prazosin integrated behavioral sleep intervention IBSI and placebo PLA on post deployment-related sleep disturbances 2 To compare the efficacy of pharmacological and behavioral interventions adjunct sleep focused interventions 3 To evaluate and compare the durability of active sleep-focused interventions on sleep daytime PTSD symptoms mood and anxiety by conducting a naturalistic follow-up assessment 4 months after the end-of-treatment assessment A secondary aim is to identify demographic psychosocial and clinical predictors of sleep treatment response in military veterans
Participants will be recruited from the Pittsburgh VA Health Care System clinics and services Treatments will be administered over an eight-week period for all conditions Primary outcome measures include 1 Sleep Quality as determined by polysomnographic sleep recordings and global scores on the Pittsburgh Sleep Quality Index PSQI and PSQI Addendum for PTSD PSQI-A Sleep response will be defined as a sleep latency 30 minutes and wake time after sleep onset 30 minutes and a sleep efficiency 85 as determined by sleep diaries and in-home sleep studies or a decrease in 5 points on the Pittsburgh Sleep Quality Index Secondary outcome measures include PTSD symptom severity as determined by the Clinician-Administered PTSD scale Part 2 and the self-report PTSD Symptom Checklist-Military version depression severity as determined by the Beck Depression Inventory anxiety Beck Anxiety Inventory 4 health-related quality of life SF-36 A naturalistic follow-up assessment will be conducted four months post-treatment
The proposed study will contribute to the development of effective therapeutic strategies for PTSD This study will provide novel information regarding predictors of sleep treatment response in PTSD which will contribute to facilitating care management in PTSD
The overarching objective of this study is to investigate and compare the efficacy and durability of adjunct sleep-focused interventions on sleep daytime PTSD symptomatology and mood in a sample of 90 male and female veterans who experience nightmares and insomnia The specific aims and hypotheses are 1 To investigate the efficacy of prazosin integrated behavioral sleep intervention IBSI and placebo PLA on post deployment-related sleep disturbances 2 To compare the efficacy of pharmacological and behavioral interventions adjunct sleep focused interventions 3 To evaluate and compare the durability of active sleep-focused interventions on sleep daytime PTSD symptoms mood and anxiety by conducting a naturalistic follow-up assessment 4 months after the end-of-treatment assessment A secondary aim is to identify demographic psychosocial and clinical predictors of sleep treatment response in military veterans
Participants will be recruited from the Pittsburgh VA Health Care System clinics and services Treatments will be administered over an eight-week period for all conditions Primary outcome measures include 1 Sleep Quality as determined by polysomnographic sleep recordings and global scores on the Pittsburgh Sleep Quality Index PSQI and PSQI Addendum for PTSD PSQI-A Sleep response will be defined as a sleep latency 30 minutes and wake time after sleep onset 30 minutes and a sleep efficiency 85 as determined by sleep diaries and in-home sleep studies or a decrease in 5 points on the Pittsburgh Sleep Quality Index Secondary outcome measures include PTSD symptom severity as determined by the Clinician-Administered PTSD scale Part 2 and the self-report PTSD Symptom Checklist-Military version depression severity as determined by the Beck Depression Inventory anxiety Beck Anxiety Inventory 4 health-related quality of life SF-36 A naturalistic follow-up assessment will be conducted four months post-treatment
The proposed study will contribute to the development of effective therapeutic strategies for PTSD This study will provide novel information regarding predictors of sleep treatment response in PTSD which will contribute to facilitating care management in PTSD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| W81XWH-06-1-0257 | None | None | None |