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START for Post-Traumatic Stress Disorder (START-PTSD Trial)
N/A
Waitlist Available
Led By Amanda Medley Raines, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Veterans with diagnosis of PTSD who decline trauma focused treatment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
Awards & highlights
START-PTSD Trial Summary
This trial will test whether a treatment called START can help reduce symptoms of PTSD in Veterans. It is hypothesized that START will be more effective than just waiting for treatment.
Who is the study for?
This trial is for Veterans at the New Orleans VA with PTSD who are not currently in psychotherapy and have declined trauma-focused treatment. It's not open to those with severe suicidal intent, active psychosis, substance dependence needing detox, or uncontrolled Bipolar Disorder.Check my eligibility
What is being tested?
The study tests a new approach called START for reducing PTSD symptoms against a wait-list control group. Participants will be randomly assigned to either receive the START treatment immediately or placed on a waiting list.See study design
What are the potential side effects?
Since this is a psychological intervention rather than medication, typical side effects like nausea or headache aren't expected. Emotional discomfort due to discussing traumatic events may occur.
START-PTSD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran with PTSD and I choose not to undergo trauma-focused treatment.
START-PTSD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in PTSD diagnostic status as measured by the Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Change in PTSD symptoms as measured by the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Changes in safety aid usage as measured by the Safety Behavior Assessment Form (SBAF)
+1 moreSecondary outcome measures
Changes in PTSD cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI)
Changes in anxiety as measured by the Beck Anxiety Inventory (BAI)
Changes in depression as measured by the Beck Depression Inventory-II (BDI-II)
+1 moreSTART-PTSD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ActiveExperimental Treatment1 Intervention
Active arm- START-PTSD
Group II: ControlActive Control1 Intervention
Control arm
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,383 Total Patients Enrolled
Amanda Medley Raines, PhDPrincipal InvestigatorSoutheast Louisiana Veterans Health Care System, New Orleans, LA
Amanda M Raines, PhDPrincipal InvestigatorSoutheast Louisiana Veterans Health Care System, New Orleans, LA
1 Previous Clinical Trials
32 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently experiencing a severe mental disorder that affects your thoughts, emotions, and behavior.I am a veteran with PTSD and I choose not to undergo trauma-focused treatment.My bipolar disorder is not under control.I am currently seeing a therapist for mental health support.You are addicted to a substance and need to go through detoxification.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What outcome is this research endeavor working to attain?
"The primary goal of this clinical trial, which will last for 10 weeks, is to gauge any changes in PTSD diagnostic status as determined by the Clinician Administered PTSD Scale (CAPS-5). Secondary objectives consist of analysing shifts in anxiety levels using the Beck Anxiety Inventory (BAI), depression severity through the Beck Depression Inventory-II (BDI-II), and functional impairment with the Sheehan Disability Scale (SDS) at baseline, post-intervention or waitlist period, and one month after."
Answered by AI
Are there any remaining openings for participation in this trial?
"Contrary to what one might assume, clinicaltrials.gov shows that this trial is not accepting participants at present. Initially posted on October 1st 2023, the study was last modified on October 20th 2022. Nonetheless, there are 343 other trials currently in need of volunteers as an alternative option."
Answered by AI
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