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Emotion Regulation Techniques for Post-Traumatic Stress Disorder and Alcoholism (SERA Trial)

N/A

Waitlist Available

Led By Cathryn Glanton Holzhauer, 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

Be older than 18 years old

Must not have

Brain damage or were in an accident that affects ability to complete the computerized task

Timeline

Screening 3 weeks

Treatment Varies

Follow Up retrospectively for 45 days prior to study enrollment, and through study completion (up to 75 days post-baseline)

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how stress and negative emotions affect alcohol use in female veterans, especially those with PTSD. It also looks at how well emotion regulation techniques work in these women and how a woman's reaction to stress varies during her menstrual cycle.

Who is the study for?

This trial is for U.S. military women veterans who have used alcohol in the last 45 days and misuse it, with alcohol being their main substance if using others. They must speak English, be willing to give blood samples and take home ovulation tests. Those with psychotic symptoms, uncontrolled bipolar disorder, current pregnancy or recent suicidal thoughts are excluded.

What is being tested?

The study examines how stress and negative emotions affect behaviors like alcohol use among women veterans with or without PTSD. It also explores if emotion regulation techniques can alter these effects and how hormonal changes during menstrual cycles influence stress responses.

What are the potential side effects?

Since this trial involves psychoeducation and cognitive reappraisal interventions rather than medication, typical medical side effects are not expected; however, discussing traumatic experiences may cause temporary emotional discomfort.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain damage or was in an accident that affects my ability to perform tasks on a computer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ retrospectively for 45 days prior to study enrollment, and through study completion (up to 75 days post-baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~retrospectively for 45 days prior to study enrollment, and through study completion (up to 75 days post-baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and retrospectively for 45 days prior to study enrollment, and through study completion (up to 75 days post-baseline) 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 Alcohol Craving during Experimental Sessions

Change in Heart Rate Variability (HRV) during Experimental Sessions

Change in Inhibitory Control during Experimental Sessions

+1 more

Secondary study objectives

Change in depression symptoms from baseline to study completion, un to 75 days

Change in intensity of daily negative affect

Change in use of adaptive and maladaptive emotion regulation strategies

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Reappraisal MicrointerventionExperimental Treatment1 Intervention

The CR microintervention (session 1) is drawn from Barlow \& colleagues empirically supported treatment for emotional disorders (the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders). The microintervention consist of four sections: (1) Introduction to cognitive appraisal; (2) Introducing the idea of "thinking traps" that prevent reappraisal and maintain negative emotion; (3) Describing cognitive reappraisal as a strategy that can help the participant "get out" of such thinking traps; (4) Providing an example of this process (situation\> negative appraisal \> negative emotion \> thinking trap \> opportunity for cognitive reappraisal) and have participants provide a personalized example.

Group II: Psychoeducation (Control)Active Control1 Intervention

The manualized psychoeducational control module, serving as an attentional control, is derived from two sources: 1. The first session of the Women's Health Education Manual, which provides psychoeducation about the basic body systems and their function, with focus on components of the immune system and 2. Fact sheets published by the American College of Obstetricians and Gynecologists(ACOG), providing female-specific facts about cancer and heart health. None of this psychoeducation discusses potential relevancy of alcohol use, nor will any behavior changes be suggested during the control microintervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Reappraisal

2020

N/A

~90

0 / 1Eligibility criteria met