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Written Exposure Therapy for Post-Traumatic Stress Disorder

N/A

Waitlist Available

Led By Jesse McCann, MS

Research Sponsored by Jesse McCann

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Fluent in English (including being able to read and write in English)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in prior week symptom severity assessed with self-report scale from 3 or 5 weeks prior to beginning treatment, compared to weekly during treatment, and compared weekly to 4 weeks after completing treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will use Single Case Experimental Design to study the effects of WET in reducing both PTSD symptoms and trauma-related mental contamination among individuals with PTSD resulting from sexual trauma.

Who is the study for?

This trial is for adults who have experienced sexual trauma, can read and write in English, and are currently dealing with PTSD symptoms and mental contamination. They must not be starting new trauma-related treatments or changing their stable psychotropic medication doses during the study.

What is being tested?

The trial tests Written Exposure Therapy (WET), a brief treatment involving writing about one's traumatic experience over five sessions. The goal is to see if WET reduces PTSD symptoms and feelings of internal 'dirtiness' without physical contact, known as mental contamination.

What are the potential side effects?

While not explicitly listed, potential side effects may include temporary increases in distress due to recalling traumatic events during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can speak, read, and write in English fluently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in prior week symptom severity assessed with self-report checklist from 3 or 5 weeks prior to beginning treatment, compared to weekly during treatment, and compared weekly to 4 weeks after completing treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in prior week symptom severity assessed with self-report checklist from 3 or 5 weeks prior to beginning treatment, compared to weekly during treatment, and compared weekly to 4 weeks after completing treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in prior week symptom severity assessed with self-report checklist from 3 or 5 weeks prior to beginning treatment, compared to weekly during treatment, and compared weekly to 4 weeks after completing treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

PTSD Checklist for DSM-5 (PCL-5)

Posttraumatic Experience of Mental Contamination Scale (PEMC)

Side effects data

From 2023 Phase 2 trial • 16 Patients • NCT04889664

85%

Fatigue

69%

Other

38%

Dizziness

38%

Headache

23%

Blurred Vision

15%

Difficulty Sleeping

15%

Frequent Urination

15%

Menstrual Irregularity

15%

Nausea/vomiting

Increased Perspiration

Decreased energy

Anxiety

100%

80%

60%

40%

20%

Study treatment Arm

Ketamine and Written Exposure Therapy

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

Group I: 5-Week BaselineExperimental Treatment1 Intervention

Participants in this arm are randomized to a 5-week baseline period with repeated weekly assessment after the initial intake. Following the 5-week baseline, participants receive 5 weekly sessions of Written Exposure Therapy (WET) followed by a 4-week follow-up phase with repeated weekly assessments, including a post-study evaluation one week after ending WET.

Group II: 3-Week BaselineExperimental Treatment1 Intervention

Participants in this arm are randomized to a 3-week baseline period with repeated weekly assessment after the initial intake. Following the 3-week baseline, participants receive 5 weekly sessions of Written Exposure Therapy (WET) followed by a 4-week follow-up phase with repeated weekly assessments, including a post-study evaluation one week after ending WET.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Written Exposure Therapy

2021

Completed Phase 2

~370

0 / 2Eligibility criteria met