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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

18 years of age or older

Be older than 18 years old

Must not have

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.

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have untreated severe mental health issues or eating disorders.

Timeline

Screening ~ 3 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PTSD Checklist for DSM-5 (PCL-5)

Posttraumatic Experience of Mental Contamination (PEMC)

Secondary study objectives

Trauma-Related Guilt Inventory (TRGI)

Trauma-Related Shame Inventory (TRSI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~4030

0 / 2Eligibility criteria met