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Emotion Regulation Techniques for Post-Traumatic Stress Disorder and Alcoholism (SERA Trial)
N/A
Recruiting
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
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
SERA Trial 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.Check my eligibility
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.See study design
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.
SERA Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Alcohol Craving during Experimental Sessions
Change in Heart Rate Variability (HRV) during Experimental Sessions
Change in Inhibitory Control during Experimental Sessions
+1 moreSecondary outcome measures
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
SERA 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,104 Total Patients Enrolled
41 Trials studying Alcoholism
6,259 Patients Enrolled for Alcoholism
Cathryn Glanton Holzhauer, PhDPrincipal InvestigatorVA Central Western Massachusetts Healthcare System, Leeds, MA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to give blood samples and do urine ovulation tests at home.I have brain damage or was in an accident that affects my ability to perform tasks on a computer.You have had thoughts or plans to harm yourself in the past 3 months.If you use drugs illegally, you primarily use alcohol.You have been in the United States military.You have consumed alcohol in the last 45 days.You currently drink alcohol excessively, which is determined by scoring 3 or higher on a test called the AUDIT-C.
Research Study Groups:
This trial has the following groups:- Group 1: Psychoeducation (Control)
- Group 2: Cognitive Reappraisal Microintervention
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.
Are people still able to sign up for this experiment?
"That is correct, the trial is still admitting patients. The information on clinicaltrials.gov indicates that the study was first posted on November 1st 2020 and was last updated on August 29th 2022. They are looking for 80 participants from a single site."
Answered by AI
How many research subjects are being accepted into the program?
"The latest information available on clinicaltrials.gov reveals that this particular trial is still looking for subjects. This experiment was originally advertised on November 1st 2020 with the most recent update being from August 29th 2022. They are recruiting 80 individuals from a single location."
Answered by AI
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