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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
Must not have
Uncontrolled Bipolar Disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a veteran with PTSD and I choose not to undergo trauma-focused treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My bipolar disorder is not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention or wait-list (10-weeks), and one-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention or wait-list (10-weeks), and one-month follow-up for reporting.

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 more
Secondary 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 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ActiveExperimental Treatment1 Intervention
Active arm- START-PTSD
Group II: ControlActive Control1 Intervention
Control arm

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for PTSD include trauma-focused psychotherapies and pharmacotherapies. Trauma-focused therapies, such as cognitive processing therapy and exposure therapy, help patients process and reframe traumatic memories, reduce avoidance behaviors, and improve emotional regulation. Pharmacotherapies, like SSRIs and SNRIs, work by correcting neurotransmitter imbalances to alleviate symptoms such as anxiety, depression, and hyperarousal. The START trial, which focuses on reducing safety aid behaviors, aims to decrease reliance on avoidance strategies that can perpetuate PTSD symptoms. Understanding these mechanisms is essential for PTSD patients as it clarifies how these treatments can help alleviate their symptoms and enhance their overall well-being.
Treating posttraumatic stress disorder in first responders: a systematic review.Providing a treatment rationale for PTSD: does what we say matter?

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,909 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

Media Library

Safety Aid Reduction Treatment for PTSD Clinical Trial Eligibility Overview. Trial Name: NCT04515784 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Active, Control
Post-Traumatic Stress Disorder Clinical Trial 2023: Safety Aid Reduction Treatment for PTSD Highlights & Side Effects. Trial Name: NCT04515784 — N/A
Safety Aid Reduction Treatment for PTSD 2023 Treatment Timeline for Medical Study. Trial Name: NCT04515784 — N/A
~35 spots leftby Sep 2024