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Cognitive Processing + Self-Compassion Therapies for PTSD (HRT Trial)

N/A
Recruiting
Led By Christal L Badour, PhD
Research Sponsored by Christal L Badour
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

HRT Trial Summary

This trialwill assess whether Cognitive Processing Therapy (CPT) and Self-Compassion (SC) interventions reduce trauma-related mental contamination and PTSD symptoms among individuals who experienced sexual trauma.

Who is the study for?
This trial is for adults over 18 who speak English, have experienced sexual trauma, and are currently dealing with PTSD and feelings of internal 'dirtiness' or mental contamination. They must not be starting new trauma treatments during the study, should maintain a stable dose if on psychotropic meds, and meet certain criteria for PTSD severity.Check my eligibility
What is being tested?
The study tests Cognitive Processing Therapy (CPT), a standard treatment for PTSD that helps with shame and guilt over 12 sessions, against Self-Compassion (SC) therapy—a newer method focusing on self-kindness over six sessions—to see which better reduces PTSD symptoms and mental contamination from sexual trauma.See study design
What are the potential side effects?
While specific side effects aren't listed as this is psychological therapy rather than medication, participants may experience emotional discomfort or increased distress while confronting traumatic memories or challenging personal beliefs related to their trauma.

HRT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of my mental health medication for at least 4 weeks.
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I have PTSD from past sexual trauma and feel mentally contaminated by it.
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I am 18 years old or older.
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I agree not to seek other trauma-related treatments during the study.

HRT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PTSD Checklist for DSM-5 (PCL-5)
Posttraumatic Experience of Mental Contamination (PEMC)
Secondary outcome measures
Trauma-Related Guilt Inventory (TRGI)
Trauma-Related Shame Inventory (TRSI)

HRT Trial Design

4Treatment groups
Experimental Treatment
Group I: 4 week baseline, SC + CPTExperimental Treatment2 Interventions
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).
Group II: 4 week baseline, CPT + SCExperimental Treatment2 Interventions
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).
Group III: 2 week baseline, SC + CPTExperimental Treatment2 Interventions
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).
Group IV: 2 week baseline, CPT + SCExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Processing Therapy
2016
N/A
~3400

Find a Location

Who is running the clinical trial?

Christal L BadourLead Sponsor
1 Previous Clinical Trials
21 Total Patients Enrolled
Christal L Badour, PhDPrincipal Investigator - University of Kentucky
University of Kentucky
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Cognitive Processing Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04585685 — N/A
Guilt Research Study Groups: 2 week baseline, SC + CPT, 4 week baseline, SC + CPT, 4 week baseline, CPT + SC, 2 week baseline, CPT + SC
Guilt Clinical Trial 2023: Cognitive Processing Therapy Highlights & Side Effects. Trial Name: NCT04585685 — N/A
Cognitive Processing Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04585685 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for volunteers to partake in this research endeavor?

"Affirmative. Information housed on clinicaltrials.gov attests to the fact that this medical study, which was initially posted on September 10th 2020, is actively recruiting patients. Approximately 12 volunteers will be sourced from one site for participation in this trial."

Answered by AI

How many individuals are being monitored as part of this research endeavor?

"Confirmed. Clinicaltrials.gov highlights that this experimental research, first posted on September 10th 2020, is now recruiting patients. The study requires 12 volunteers to be gathered from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
University of Kentucky Clinic for Emotional Health (CEH)
~1 spots leftby Oct 2024