Reclaiming Your Life After Sexual Trauma

NCT05268367 | Terminated

• 1 other identifier: 69410
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Mental contamination-an internal experience of dirtiness evoked in the absence of physical contact with an external source-has been linked to the development and maintenance of posttraumatic stress disorder (PTSD) following exposure to sexual abuse or assault (Adams et al., 2014; Badour et al., 2013; Brake et al., 2017). Mental contamination has been associated with greater PTSD severity (Rachman et al., 2015) and higher elevations in specific PTSD symptom clusters (particularly those of intrusive re-experiencing, negative cognitions/mood, and arousal/reactivity; Brake et al., 2019; Fergus \& Bardeen, 2016). Additionally, trauma-related mental contamination has been linked to a number of negative posttraumatic emotions such as shame, guilt, disgust, and anger (Fairbrother \& Rachman, 2004; Radomsky \& Elliott, 2009). Despite clear and consistent links between mental contamination and problematic posttraumatic outcomes following sexual trauma, there is a dearth of research investigating how existing or promising new interventions for PTSD impact mental contamination. Written Exposure Therapy (WET) is a five-session treatment for PTSD that was designed to be both brief and easy to administer (Sloan et al., 2012). According to Sloan and colleagues' (2012) protocol, sessions broadly involve 30-minute exposures in which the patient writes about the events of their trauma in detail, followed by 10 minutes of discussing the exposure with the therapist. This treatment protocol has minimal therapist involvement, no homework assignments, and shorter treatment sessions. Research shows that WET is efficacious among different samples (e.g., survivors of motor vehicle accidents and combat veterans), has low dropout rates, treatment satisfaction is high, and the gains seen by participants after completion are maintained at follow-up (Sloan et al., 2012, 2013, 2018; Thompson-Hollands et al., 2018, 2019). Given these factors, WET has the potential to be a useful intervention in reducing symptoms of PTSD among a sample of survivors of sexual trauma. Given its relevance to this trauma population, a test of this intervention for its impact on reducing trauma-related mental contamination is also needed. The current study will use Single Case Experimental Design to isolate and evaluate the effects of WET in reducing both PTSD symptoms and trauma-related mental contamination among individuals with PTSD resulting from sexual trauma. Aims: Explore whether participants demonstrate reductions in mental contamination and PTSD symptoms in response to 5 sessions of WET. Visual inspection analysis and statistical methods will be used to draw conclusions regarding the effects of the interventions on PTSD symptoms and mental contamination.

Conditions

Stress Disorders, Post-Traumatic; Sexual Assault and Rape

Keywords

Posttraumatic Stress Disorder (PTSD); Mental Contamination; Written Exposure Therapy; Sexual Trauma

Outcome Measures

Primary Outcomes (2)

• PTSD Checklist for DSM-5 (PCL-5)

  Change in Posttraumatic Stress Disorder Severity

  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

• Posttraumatic Experience of Mental Contamination Scale (PEMC)

  Change in Mental Contamination Severity

  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

Study Arms (2)

3-Week Baseline

EXPERIMENTAL

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.

Behavioral: Written Exposure Therapy

5-Week Baseline

EXPERIMENTAL

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.

Behavioral: Written Exposure Therapy

Interventions

Written Exposure Therapy BEHAVIORAL

A brief exposure-based psychotherapy for posttraumatic stress disorder

3-Week Baseline; 5-Week Baseline

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals with a history of sexual trauma meeting past-month diagnostic criteria for PTSD (meeting diagnostic status on the DIAMOND and score greater than or equal to 33 on the PCL-5)
• individuals reporting current experiences of trauma-related mental contamination (greater than or equal to 30 on the PEMC and endorsement of current mental contamination at the time of the intake assessment)
• years of age or older
• fluent in English (including being able to read and write in English)
• patients on psychotropic medications will be included if they have been maintained on a stable dose for at least 4 weeks prior to beginning the study and are willing to maintain a stable dosage throughout the study period; this procedure allows for a broader range of participants and avoids having outcomes assessment confounded by the initiation of medication during treatment
• patients must be willing to refrain from additional trauma-related treatment for the duration of the study.

You may not qualify if:

• We will exclude individuals diagnosed with psychological conditions that may be better addressed by alternative treatments; these conditions may include:
• any history of psychotic disorders or dissociative identity disorder
• manic episodes endorsed in the past year
• current anorexia nervosa
• imminent risk of suicide (i.e., intent/plan)
• severe substance use disorders.
• We will also exclude individuals who endorse factors for which the treatment being studied (WET) may be contraindicated. These factors may include having no or limited memory of the trauma that would prevent the individual from engaging in written exposures.

Sponsors & Collaborators

• Jesse McCann: lead

Study Sites (1)

University of Kentucky Clinic for Emotional Health (CEH)

Lexington, Kentucky, 40504, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sexual Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Christal L Badour, PhD

  University of Kentucky

  STUDY DIRECTOR

• Jesse McCann, MS

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctoral Student

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 7, 2022
• Study Start: March 31, 2022
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)