Cognitive Processing + Self-Compassion Therapies for PTSD

(HRT Trial)

Overseen By Christal L Badour, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Christal L Badour

Disqualifiers: Psychotic disorders, Bipolar, Eating disorders, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 21 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how two therapies, Cognitive Processing Therapy (CPT) and Self-Compassion Therapy (SC), reduce symptoms of PTSD and feelings of mental contamination (a sense of dirtiness linked to trauma) in individuals who have experienced sexual trauma. The study will test various sequences of these therapies to determine which is most effective. It seeks participants with PTSD from sexual trauma who frequently feel mentally contaminated. Participants should maintain stability on any current medications and agree to avoid other trauma treatments during the study. As an unphased trial, this study provides a unique opportunity to explore innovative therapy sequences that could significantly enhance mental health outcomes.

Will I have to stop taking my current medications?

You can continue taking your current medications if they are psychotropic (affecting the mind) and you have been on a stable dose for at least 4 weeks before the study. You must also keep the dosage stable during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Processing Therapy (CPT) is a well-known and safe treatment for PTSD. One study found that 14.7% of patients experienced minor issues during treatment, but these were not serious. Experts recommend CPT as a reliable therapy for PTSD, and it has been widely used with positive results, especially among military and veteran patients.

Self-Compassion Therapy (SC) is a newer method that involves treating oneself with kindness and understanding. Although less research exists on SC, early studies suggest it helps reduce PTSD symptoms and the feelings of shame and guilt that often accompany it. Importantly, no major safety concerns have been reported with SC.

Both therapies aim to help people with PTSD, and evidence suggests they are generally safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these therapies for PTSD because they combine Cognitive Processing Therapy (CPT) with Self-Compassion Therapy (SC), offering a unique approach to treatment. Unlike traditional PTSD treatments, which often focus solely on cognitive restructuring, this approach integrates self-kindness and emotional resilience, potentially enhancing overall emotional healing. The trial explores different sequences of these therapies to determine the most effective order, offering insights into personalized PTSD treatment strategies that could improve outcomes for individuals struggling with this condition.

What evidence suggests that this trial's treatments could be effective for PTSD?

This trial will explore the effects of combining Cognitive Processing Therapy (CPT) and Self-Compassion Therapy (SC) for PTSD. Research has shown that CPT effectively reduces symptoms like depression and improves overall well-being, with many studies supporting its effectiveness and long-lasting benefits. In contrast, SC has shown mixed results in reducing PTSD symptoms, but some research suggests it can help with trauma-related feelings, such as shame and guilt. Although SC may not have as much support as CPT, it shows promise, particularly for addressing feelings of mental contamination. Participants in this trial will receive both therapies in different sequences, potentially offering a more comprehensive approach to reducing PTSD symptoms and mental contamination. ^{1 3 6 7 8}

Who Is on the Research Team?

Christal L Badour, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been on a stable dose of my mental health medication for at least 4 weeks.

I have PTSD from past sexual trauma and feel mentally contaminated by it.

fluent in English

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Baseline

Participants undergo a baseline assessment period with weekly measures of PTSD symptoms and mental contamination

2-4 weeks

Weekly assessments (in-person or virtual)

Treatment

Participants receive either 12 sessions of Cognitive Processing Therapy (CPT) or 6 sessions of Self-Compassion Therapy (SC), followed by a 3-week return to baseline and then the alternate therapy

21 weeks

Weekly therapy sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

Weekly assessments (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Processing Therapy
• Self-Compassion Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: 4 week baseline, SC + CPT Experimental Treatment 2 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 + SC Experimental Treatment 2 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 + CPT Experimental Treatment 2 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 + SC Experimental Treatment 2 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).

Cognitive Processing Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Approved in European Union as Cognitive Processing Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Christal L Badour

Lead Sponsor

Trials

3

Recruited

130+

Published Research Related to This Trial

In a study of 420 veterans with PTSD, those receiving Seeking Safety (SS) had a higher treatment completion rate (89%) compared to those receiving cognitive processing therapy (CPT) (50%), indicating SS may be more acceptable for veterans.

However, veterans who completed CPT showed significantly greater reductions in PTSD symptoms, as measured by the PTSD checklist, suggesting that while SS is easier to complete, CPT may be more effective in reducing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. Baig, MR., Ouyang, S., Mata-Galán, E., et al.[2021]

Cognitive Processing Therapy (CPT) is an effective evidence-based treatment for PTSD, particularly for individuals who have experienced combat, assault, or interpersonal violence, as supported by randomized controlled trials.

The Department of Veterans Affairs has successfully implemented CPT across its healthcare system, with trained clinicians showing good adoption of the therapy and significant improvements in patients' PTSD and depressive symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. Chard, KM., Ricksecker, EG., Healy, ET., et al.[2022]

Cognitive processing therapy (CPT) effectively reduces PTSD symptoms in trauma survivors, as shown in a study with 266 veterans, regardless of their level of self-blame.

Both veterans with low and high self-blame experienced significant improvements in PTSD symptoms, indicating that CPT is beneficial for all individuals, irrespective of their self-perception related to the trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Self-Blame on Cognitive Processing Therapy: A Comparison of Treatment Outcomes. Stayton, LE., Dickstein, BD., Chard, KM.[2019]

In a study of 108 active duty US Army personnel with PTSD, both group cognitive processing therapy-cognitive only version (CPT-C) and group present-centered therapy (PCT) significantly reduced rates of suicide ideation, with improvements maintained for up to 12 months post-treatment.

There were no reported suicide attempts during or after treatment in either group, and exacerbation of preexisting suicide ideation was uncommon, suggesting that group CPT-C is safe and does not increase suicide risk among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. Bryan, CJ., Clemans, TA., Hernandez, AM., et al.[2019]

In a study of 65 PTSD patients undergoing therapy, components of self-compassion, such as self-kindness and reduced self-judgment, were found to significantly influence PTSD symptoms over the course of treatment, regardless of the therapy type used.

The findings suggest that decreasing self-judgment, particularly in patients with high initial levels, is crucial for improving PTSD symptoms, highlighting the importance of fostering self-compassion in therapeutic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-compassion influences PTSD symptoms in the process of change in trauma-focused cognitive-behavioral therapies: a study of within-person processes. Hoffart, A., Øktedalen, T., Langkaas, TF.[2020]

Cognitive processing therapy (CPT) is an effective treatment for PTSD in veterans, but many do not complete the full program, often receiving only four sessions instead of the full 12, highlighting the need for a more efficient treatment format.

A study involving 270 veterans used a fractional factorial design to identify the most effective components of CPT, aiming to create a shorter version that could reduce dropout rates and improve treatment accessibility for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the multiphase optimization strategy to adapt cognitive processing therapy (CPT MOST): study protocol for a randomized controlled factorial experiment. Sripada, RK., Peterson, CL., Dziak, JJ., et al.[2023]

In a study of 268 active-duty servicemembers, individual cognitive processing therapy (CPT) was found to be more effective than group CPT in reducing PTSD severity, with significant improvements noted immediately after treatment.

Both individual and group formats of CPT led to reductions in depression and suicidal ideation, but about 50% of participants still experienced PTSD symptoms after treatment, highlighting the need for improved or new therapeutic options in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. Resick, PA., Wachen, JS., Dondanville, KA., et al.[2022]

A systematic review of 35 studies indicates that higher levels of self-compassion are consistently linked to lower symptoms of PTSD, suggesting that fostering self-compassion may be beneficial for individuals with trauma histories.

There is preliminary evidence that self-compassion-based interventions could help reduce PTSD symptoms, although the exact mechanisms behind these effects remain unclear and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-compassion, trauma, and posttraumatic stress disorder: A systematic review. Winders, SJ., Murphy, O., Looney, K., et al.[2021]

Cognitive processing therapy (CPT) significantly improved various domains of psychosocial functioning in 78 women with PTSD, regardless of whether they received the full treatment or just its components.

Reductions in PTSD symptoms, particularly emotional numbing and hyperarousal, were strongly associated with improvements in psychosocial functioning, highlighting the importance of addressing these symptoms during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between functioning and PTSD symptom clusters in a dismantling trial of cognitive processing therapy in female interpersonal violence survivors. Shnaider, P., Vorstenbosch, V., Macdonald, A., et al.[2018]

Cognitive Processing Therapy for sexual abuse survivors (CPT-SA) was found to be significantly more effective than minimal attention (MA) in reducing trauma-related symptoms, based on a study involving 71 women.

The benefits of CPT-SA were not only immediate but also sustained over a period of one year, indicating its long-term efficacy in treating PTSD and related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of cognitive processing therapy for the treatment of posttraumatic stress disorder related to childhood sexual abuse. Chard, KM.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39908018/

Cognitive Processing Therapy for Posttraumatic Stress ... In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589979124000027

Effectiveness of Cognitive Processing Therapy for PTSD in ... Results: The results demonstrated statistically significant changes in PTSD and depression symptoms and improvement in end-state functioning. Conclusion: ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829857

Cognitive Processing Therapy for Posttraumatic Stress ... The CPT-TAU group maintained improvements in all outcomes from 17 to 34 weeks. Sensitivity analyses controlling for the types of traumatic ...

4. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/cpt_for_ptsd_pro.asp

Cognitive Processing Therapy for PTSD Participants in the active treatment conditions (both CPT and PE) demonstrated significant improvement in PTSD and depression over the course of treatment as ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30332919/

A meta-analytic review of cognitive processing therapy for ... These meta-analytic findings indicate that CPT is an effective PTSD treatment with lasting benefits across a range of outcomes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04230668

NCT04230668 | Cognitive Processing Therapy (CPT) for ... A pilot effectiveness trial of cognitive processing therapy augmented with suicide risk management for individuals with comorbid PTSD and BPD conditions.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11800015/

Cognitive Processing Therapy for Posttraumatic Stress ... Cognitive processing therapy (CPT) is an evidence-based treatment for posttraumatic stress disorder (PTSD). However, there is little evidence on ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1077722922001377

Clinician Concerns About Cognitive Processing Therapy A secondary analysis of randomized clinical trial data showed that 14.7% of patients receiving CPT and 28.6% of clients receiving CPT with a written trauma ...