What side effects are associated with this type of intervention?

The most common treatments for PTSD include SSRIs (Selective Serotonin Reuptake Inhibitors), SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors), and trauma-focused therapies like Cognitive Behavioral Therapy (CBT) and exposure therapy. SSRIs and SNRIs can cause side effects such as weight gain, sexual dysfunction, insomnia, and gastrointestinal issues. Trauma-focused therapies, while generally safe, may initially increase distress as patients confront traumatic memories. However, these therapies do not have the pharmacological side effects associated with medications.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications have been shown to reduce PTSD symptoms effectively. Additionally, serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine have also demonstrated efficacy in clinical trials. While the START trial focuses on reducing safety aid behaviors, it is important to note that trauma-focused cognitive-behavioral therapies (CBT) and exposure therapies are also widely recognized and effective treatments for PTSD, often used in conjunction with pharmacotherapy.

What other types of research exist?

Promising novel alternatives to START for PTSD treatment in 2024 include MDMA-assisted psychotherapy, which has shown efficacy in reducing PTSD symptoms, and psilocybin-assisted psychotherapy, which has demonstrated potential in treating psychiatric and existential distress. Additionally, trauma-focused cognitive behavioral therapy (TF-CBT) and eye movement desensitization and reprocessing (EMDR) continue to be effective options.

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START for Post-Traumatic Stress Disorder (START-PTSD Trial)

N/A

Recruiting

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 (10-weeks), and one-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment called START, which helps veterans with PTSD reduce their reliance on anxiety-avoiding behaviors. It targets veterans who avoid traditional PTSD therapies. By reducing these 'safety aids,' the treatment aims to help them face their fears and feel less anxious over time.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, post-intervention (10-weeks), and one-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, post-intervention (10-weeks), and one-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (10-weeks), and one-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ActiveExperimental Treatment1 Intervention

Active arm- START-PTSD

0 / 2Eligibility criteria met

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?