Helping individuals recover from trauma and PTSD
Healthy Recovery After Trauma Study
NA · University of Kentucky · NCT04585685
This study is testing two different therapies to see which one helps people with PTSD from sexual trauma feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky (other) |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT04585685 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of cognitive processing therapy and self-compassion therapy on individuals with post-traumatic stress disorder (PTSD) stemming from sexual trauma. It employs a multiple baseline single case experimental design, screening up to 100 participants to identify 12 eligible individuals who will undergo a series of assessments and interventions over a period of up to 34 weeks. Participants will alternate between two different therapeutic approaches, allowing researchers to evaluate the effectiveness of each method in addressing trauma-related mental contamination and associated emotional distress.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of sexual trauma who meet diagnostic criteria for PTSD and experience trauma-related mental contamination.
Not a fit: Patients with psychological conditions that may be better addressed by other treatments or those not meeting the study's specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective therapeutic options for individuals suffering from PTSD and related emotional challenges after sexual trauma.
How similar studies have performed: While the specific combination of therapies in this study may be novel, previous studies have shown promise in using cognitive processing therapy and self-compassion approaches for PTSD treatment.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lexington, Kentucky
- University of Kentucky Clinic for Emotional Health (CEH) — Lexington, Kentucky, United States (RECRUITING)
Study contacts
- Principal investigator: Christal L Badour, PhD — University of Kentucky
- Study coordinator: Christal L Badour, PhD
- Email: Christal.badour@uky.edu
- Phone: 859-323-3817
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stress Disorders, Post-Traumatic, Shame, Guilt, Sexual Assault and Rape, post-traumatic stress disorder, mental contamination, cognitive processing therapy, self-compassion