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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Cognitive Processing Therapy (CPT) and Self-Compassion Therapy (SC) for PTSD?

Research shows that Cognitive Processing Therapy (CPT) is effective in reducing PTSD symptoms, especially in trauma survivors who experience self-blame. Additionally, CPT has been shown to improve daily functioning and reduce trauma-related symptoms in various groups, including military veterans and survivors of interpersonal violence. ^{1 2 3 4 5}

Is Cognitive Processing Therapy (CPT) safe for treating PTSD?

Cognitive Processing Therapy (CPT) has been widely used and studied for treating PTSD, particularly in veterans and military personnel. While there is no specific mention of safety concerns in the provided studies, one study evaluated the potential risk of increased suicidal thoughts in a group setting, which is an important consideration. Overall, CPT is generally considered safe, but as with any therapy, monitoring by a healthcare professional is recommended. ^{1 4 6 7 8}

How is the Cognitive Processing + Self-Compassion Therapies treatment for PTSD different from other treatments?

This treatment is unique because it combines Cognitive Processing Therapy (CPT), which is a structured approach to help patients challenge and modify unhelpful beliefs related to trauma, with Self-Compassion Therapy, which focuses on fostering self-kindness and understanding. This combination aims to reduce PTSD symptoms by addressing self-blame and promoting a compassionate self-view, which is not typically emphasized in standard PTSD treatments. ^{1 2 4 9 10}

Research Team

Christal L Badour, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of Self-Blame on Cognitive Processing Therapy: A Comparison of Treatment Outcomes. [2019]

2. England 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. [2023]

3. United States 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. [2018]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Cognitive Processing Therapy and Seeking Safety for the Treatment of Posttraumatic Stress Disorder in Veterans. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Dissemination and experience with cognitive processing therapy. [2022]

9. Switzerland 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. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Self-compassion, trauma, and posttraumatic stress disorder: A systematic review. [2021]