| NCT ID | NCT04585685 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Christal L Badour |
| Condition | Stress Disorders, Post-Traumatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2020-09-10 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2020-09-10 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 reexperiencing, 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. Cognitive Processing Therapy (CPT) is an efficacious and effective 12-session manualized cognitive-behavioral intervention for PTSD that is considered a gold-standard empirically-supported treatment for PTSD that is recommended by the American Psychological Association (APA, 2017). In addition to PTSD symptom improvement, CPT has also demonstrated benefit for improving feelings of shame and guilt, which are often seen among individuals with trauma-related mental contamination (Nishith et al., 2005; Resick et al., 2002, 2008). Cognitive reappraisal, a primary technique employed in CPT, involves challenging one's view of an emotionally-eliciting situation to alter its emotional impact (Gross \& John, 2003). However, some investigators have suggested that cognitive reappraisal may be less effective in targeting moral emotions such as shame, guilt, and self-disgust that are based on an individual's standards and virtues (Finlay, 2015). Self-compassion (SC; i.e., self-directed care and kindness; forgiveness; and feelings of common humanity; Neff, 2003) has been proposed as an alternative method for addressing trauma-related shame and preliminary evidence suggests a 6-session self-compassion intervention may have benefit for reducing both PTSD symptoms and trauma-related shame (Au et al., 2017). Given the centrality of shame, guilt, and self-disgust to the experience of mental contamination, and the fact that mental contamination often arises in response to experiences involving moral violation or betrayal (Millar et al., 2016; Rachman, 2010), a SC intervention for PTSD may also offer promise as a standalone or adjunctive intervention for reducing trauma-related mental contamination. A test of these interventions for their impact on reducing trauma-related mental contamination is needed. The current study will use Single Case Experimental Design to isolate and evaluate the effects of CPT and SC in reducing both PTSD symptoms and trauma-related mental contamination among individuals with PTSD resulting from sexual trauma. Aims: 1) explore whether participants demonstrate reductions in mental contamination and PTSD symptoms in response to 12-sessions of CPT or 6-sessions of a SC intervention; 2) evaluate whether presentation of either treatment first yields differences in symptom reduction for PTSD and/or mental contamination symptoms; 3) evaluate whether the addition of the alternative module will enhance reductions in PTSD symptoms and mental contamination; 4) evaluate if such reductions are maintained during follow-up. Visual inspection analysis and statistical methods will be used to draw conclusions regarding the effects of the interventions on PTSD symptoms and mental contamination.
Eligibility Criteria
Inclusion Criteria: * 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 36 on the PCL-5) and * reporting current experiences of trauma-related mental contamination (greater than or equal to 10 on the PEMC). * 18 years of age or older * fluent 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. * Finally, patients must be willing to refrain from additional trauma-related treatment for the duration of the study. Exclusion Criteria: * We will exclude individuals diagnosed with psychological conditions that may be better addressed by alternative treatments; these conditions include * psychotic disorders * dissociative identity disorder * unmanaged (i.e., unmedicated or currently experiencing a manic/hypomanic episode) bipolar disorder * bulimia nervosa * anorexia nervosa * imminent risk of suicide (i.e., intent/plan) * severe substance use disorders.
Contact & Investigator
Christal L Badour, PhD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT04585685 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stress Disorders, Post-Traumatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04585685 currently recruiting?
Yes, NCT04585685 is actively recruiting participants. Contact the research team at Christal.badour@uky.edu for enrollment information.
Where is the NCT04585685 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT04585685 clinical trial?
NCT04585685 is sponsored by Christal L Badour. The principal investigator is Christal L Badour, PhD at University of Kentucky. The trial plans to enroll 12 participants.