Ignite Creation Date:
2024-05-06 @ 12:35 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01601067
Status:
COMPLETED
Last Update Posted:
2019-08-08
First Post:
2012-02-28
Brief Title:
Integrated Alcohol Disorder and PTSD Treatment
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Integrated Alcohol Disorder and PTSD Treatment
Status:
COMPLETED
Status Verified Date:
2019-08
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:
None
Brief Summary:
Comorbidity of alcohol use disorder AD and posttraumatic stress disorder PTSD is common Currently available treatments often do not lead to sustained recovery from these disorders possibly because they typically do not include exposure therapy which is considered best practice treatments for PTSD This study compares exposure-based integrated treatment to integrated coping skills psychotherapy a well disseminated practice for comorbid AD and PTSD with the hypothesis that exposure therapy will allow those with PTSD to better sustain PTSD symptom reduction and reduction in alcohol use The aim of this grant is to change common treatment practices for comorbid AD and PTSD by increasing the availability of evidence-based PTSD treatment for those with AD
Detailed Description:
Objectives Co-occurrence of alcohol use disorder AD and posttraumatic stress disorder PTSD is common Research supports exposure therapy as the front line treatment for PTSD as this approach is most likely to lead to sustained recovery from the disorder However individuals with AD are generally not offered exposure therapies because of beliefs that exposure would lead to engagement in greater alcohol use and other dangerous behaviors Most research and clinical treatment for comorbid AD and PTSD ADPTSD have involved coping skills based therapies that have generally not shown sustained reductions in alcohol use and PTSD symptoms A growing body of evidence suggests these individuals with ADPTSD are able to handle and benefit from exposure This proposed trial will compare an integrated exposure psychotherapy to an integrated coping skills psychotherapy for the treatment of ADPTSD In addition mechanisms of change for Veterans with ADPTSD in both treatment conditions including therapy process variables changes in negative affect and sleep problems will be explored This project addresses a critical barrier in the field - the widely held belief that individuals with AD and PTSD cannot tolerate exposure therapy although it is the best practice treatment for PTSD The fundamental rationale is to improve the evidence base that informs how patients with ADPTSD can attain sustained recovery The investigators propose a randomized controlled trial to evaluate an integrated exposure-based treatment for concurrent AD and PTSD The primary aim will be to conduct a randomized controlled trial to evaluate the effects of integrated exposure psychotherapy when compared to a present-focused coping skills based intervention Seeking Safety SS in 148 male and female Veterans who have AD and PTSD The hypotheses are that at post-treatment both groups will show reductions in alcohol use but the integrated exposure group will demonstrate greater reductions in PTSD symptoms than SS At 5- and 8-month post-baseline follow-up the integrated exposure group will have significantly fewer percent drinking days and fewer PTSD symptoms than SS In addition mechanisms of change in both treatment conditions will be examined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None