Healthy Recovery After Trauma Study

NCT04585685 | Recruiting

• 1 other identifier: 59226
• Study Type: interventional
• Target: 12
• 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 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.

Conditions

Stress Disorders, Post-Traumatic; Shame; Guilt; Sexual Assault and Rape

Keywords

post-traumatic stress disorder; mental contamination; cognitive processing therapy; self-compassion; shame; guilt; sexual trauma

Outcome Measures

Primary Outcomes (2)

• PTSD Checklist for DSM-5 (PCL-5)

  Change in Posttraumatic Stress Disorder Symptom Severity

  Change in prior week symptom severity assessed from 3 or 5 weeks prior to beginning treatment (intake + baseline), compared to weekly during treatment, compared to 3 weeks between treatments, and compared to 3 weeks after completing the second treatment

• Posttraumatic Experience of Mental Contamination (PEMC)

  Change in Severity of Mental Contamination Symptoms

  Change in prior week symptom severity assessed from 3 or 5 weeks prior to beginning treatment (intake + baseline), compared to weekly during treatment, compared to 3 weeks between treatments, and compared to 3 weeks after completing the second treatment

Secondary Outcomes (2)

• Trauma-Related Shame Inventory (TRSI)

  Change in prior week symptom severity assessed from 3 or 5 weeks prior to beginning treatment (intake + baseline), compared to weekly during treatment, compared to 3 weeks between treatments, and compared to 3 weeks after completing the second treatment

• Trauma-Related Guilt Inventory (TRGI)

  Change in prior week symptom severity assessed from 3 or 5 weeks prior to beginning treatment (intake + baseline), compared to weekly during treatment, compared to 3 weeks between treatments, and compared to 3 weeks after completing the second treatment

Study Arms (4)

2 week baseline, CPT + SC

EXPERIMENTAL

Participants in this arm are randomized to a 2-week baseline period with repeated weekly assessment after the initial intake. Following the 2-week baseline, participants are randomly assigned to receive 12 weekly sessions of Cognitive Processing Therapy (CPT), followed by a 3-week return to baseline period, followed by 6 weekly sessions of Self-Compassion Therapy (SC).

Behavioral: Cognitive Processing Therapy; Behavioral: Self-Compassion Therapy

2 week baseline, SC + CPT

EXPERIMENTAL

Participants in this arm are randomized to a 2-week baseline period with repeated weekly assessment after the initial intake. Following the 2-week baseline, participants are randomly assigned to receive 6 weekly sessions of Self-Compassion Therapy (SC), followed by a 3-week return to baseline period, followed by 12 weekly sessions of Cognitive Processing Therapy (CPT).

Behavioral: Cognitive Processing Therapy; Behavioral: Self-Compassion Therapy

4 week baseline, CPT + SC

EXPERIMENTAL

Participants in this arm are randomized to a 4-week baseline period with repeated weekly assessment after the initial intake. Following the 4-week baseline, participants are randomly assigned to receive 12 weekly sessions of Cognitive Processing Therapy (CPT), followed by a 3-week return to baseline period, followed by 6 weekly sessions of Self-Compassion Therapy (SC).

Behavioral: Cognitive Processing Therapy; Behavioral: Self-Compassion Therapy

4 week baseline, SC + CPT

EXPERIMENTAL

Participants in this arm are randomized to a 4-week baseline period with repeated weekly assessment after the initial intake. Following the 4-week baseline, participants are randomly assigned to receive 6 weekly sessions of Self-Compassion Therapy (SC), followed by a 3-week return to baseline period, followed by 12 weekly sessions of Cognitive Processing Therapy (CPT).

Behavioral: Cognitive Processing Therapy; Behavioral: Self-Compassion Therapy

Interventions

Cognitive Processing Therapy BEHAVIORAL

A 12-session cognitive behavioral therapy for posttraumatic stress disorder

2 week baseline, CPT + SC; 2 week baseline, SC + CPT; 4 week baseline, CPT + SC; 4 week baseline, SC + CPT

Self-Compassion Therapy BEHAVIORAL

A 6-session mindfulness based therapy for posttraumatic stress disorder aimed at enhancing self-compassion

2 week baseline, CPT + SC; 2 week baseline, SC + CPT; 4 week baseline, CPT + SC; 4 week baseline, SC + CPT

Eligibility Criteria

• Age: 18 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 36 on the PCL-5) and
• reporting current experiences of trauma-related mental contamination (greater than or equal to 10 on the PEMC).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Christal L Badour: lead

Study Sites (1)

University of Kentucky Clinic for Emotional Health (CEH)

Lexington, Kentucky, 40504, United States

RECRUITING

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christal L Badour, PhD

CONTACT

859-323-3817; Christal.badour@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: September 10, 2020
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be shared upon request from investigators beginning immediately after publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)