PATH-SS for Post-Traumatic Stress Disorder

(PATH-SS Trial)

Overseen By Jenna M Bagley, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Psychotropics

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called PATH-SS, designed to help individuals who have experienced sexual assault feel better. It aims to reduce distress, including symptoms of post-traumatic stress disorder (PTSD) and depression. Participants will undergo a single session of this therapy and will report their symptoms and feelings about the treatment afterward and one month later. College students in Ohio who have faced unwanted sexual contact and experience ongoing distress might be suitable for the trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new therapeutic approaches.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that your dose of psychotropic medications has been stable for the past 3 months.

What prior data suggests that the PATH-SS psychotherapy is safe for individuals with PTSD?

Research shows that trauma-focused treatments for PTSD (post-traumatic stress disorder) often improve health symptoms and daily life. As PATH-SS is a type of talk therapy, it is likely manageable due to the absence of medication, reducing the risk of physical side effects.

Although specific data on PATH-SS is not yet available, it aims to help individuals process traumatic experiences and focus on positive life events. This design makes it a safe option for those seeking new methods to manage PTSD and depression symptoms. Individuals who have tried similar therapies have generally found them helpful and acceptable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PATH-SS for treating PTSD because it offers a novel, single-session approach unlike traditional therapies, which often require multiple sessions over several weeks. This method combines revisiting traumatic experiences with processing positive life events, aiming to build resilience and emotional regulation in participants. It uniquely encourages patients to vividly recall and savor positive experiences, helping to counteract the negative emotions associated with PTSD. This approach could potentially provide quicker relief and foster long-term resilience, offering a fresh perspective on managing PTSD symptoms.

What evidence suggests that PATH-SS is effective for PTSD and depression symptoms?

Research has shown that focusing on positive experiences can help reduce PTSD symptoms. In this trial, participants will receive the PATH-SS intervention, which involves reflecting on both traumatic and positive life events. This method aims to help individuals manage trauma while increasing positive feelings. Those who have used similar techniques have experienced fewer PTSD and depression symptoms. Although limited data exists specifically for PATH-SS, evidence supports that focusing on positive emotions can improve mental health. ^{4 6 7 8 9}

Who Is on the Research Team?

Norah C Feeny, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a sexual assault and are dealing with related distress, including symptoms of PTSD and depression. To participate, they must complete an initial assessment to confirm eligibility.

Inclusion Criteria

Enrolled in any undergraduate, graduate, or professional program at a college or university in the state of Ohio

I experienced unwanted sexual contact or assault in college, between 12 weeks and 5 years ago.

I have moderate to severe PTSD or depression symptoms for over a month.

Exclusion Criteria

No clear memory of the event

Ongoing intimate relationship with the perpetrator

Severe self-injurious behavior or suicide attempt within the previous three months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-treatment/Baseline Assessment

Participants complete a pre-treatment/baseline assessment to confirm eligibility

1 week

1 visit (in-person)

Treatment

Participants receive one session of the PATH-SS intervention, lasting up to 2 hours

1 day

1 visit (in-person)

Post-treatment Assessment

Participants complete a post-treatment assessment of stressor-related symptoms

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PATH-SS

Trial Overview The PATH-SS psychotherapy session is being tested to see if it can reduce distress from sexual assault, specifically targeting improvements in PTSD and depression symptoms. Participants will undergo the therapy once and have follow-up assessments after one month.

How Is the Trial Designed?

Group I: PATH-SS Experimental Treatment 1 Intervention

This single-session intervention includes the following components: * Providing the PATH-SS rationale. * A review of life events (PATH of life: negative and positive). * A verbal narrative of the sexual assault (revisiting and processing as is done in imaginal exposure) * Reminiscence and processing of a major positive life event, and real-life practice to enact what was taught. In positive reminiscence, clients vividly remember the positive event providing details and focus on positive emotions. The therapist will encourage savoring of the experience and encourage facial expression of the positive emotions, so that clients do not dampen, avoid, or minimize the experience. This is particularly relevant with depression. * Summary of content, integration and consolidation of learning, application of new learning and resilience in real life as next steps.

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Published Research Related to This Trial

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

The safety of psychological interventions is critical, as adverse events (AEs) can occur and must be carefully evaluated to ensure that these interventions do not cause harm before being deemed beneficial.

There is a pressing need for standardized protocols for assessing and reporting AEs in psychological interventions to improve transparency, consistency, and ultimately enhance clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? Purgato, M., Cortese, S.[2023]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

The Mental Health Trigger Tool (MHTT) was developed to effectively identify adverse events (AEs) and mental health-related patient safety incidents (MHPSIs) in mental health settings, demonstrating a high sensitivity of 98.6% and perfect specificity of 100% based on a review of 515 patient records.

Using the MHTT, researchers found AEs in 19% and MHPSIs in 11% of patient records, indicating its practical utility in enhancing patient safety monitoring in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. Sajith, SG., Fung, DSS., Chua, HC.[2023]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559129/

Posttraumatic Stress Disorder - StatPearls - NCBI Bookshelf Characterized by a diverse array of symptoms, PTSD can affect cognition, mood, somatic experiences, and behavior, leading to chronic impairments ...

2. ptsd.va.gov ptsd.va.gov/publications/rq_docs/V34N3.pdf

Examining Functioning and Well-Being Outcomes in PTSD ... Because the field of post-traumatic stress disorder. (PTSD) has been driven by the disease model, outcomes are solely indexed by symptom change. We review ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424001897

A protocol for a pragmatic comparative effectiveness trial ... This protocol paper describes a pragmatic trial that compares outcomes of primary care patients randomized to initially receive a brief trauma-focused ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8672952/

A Review of PTSD and Current Treatment Strategies - PMC Current treatment strategies for control of trauma-associated symptoms of Post Traumatic Stress Disorder (PTSD) have recently been updated.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/wps.21269

Post‐traumatic stress disorder: evolving conceptualization ... A study conducted in 24 countries, with 71,083 respondents, found that the overall lifetime PTSD prevalence in the general population was 3.9%, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7831964/

The prevalence of post-traumatic stress disorder related ... The prevalence of PTSD symptoms was estimated to be about 18% (95%CI: 15% to 20%). These symptoms were more frequent in cohort studies (29%) compared to cross- ...

7. ptsd.va.gov ptsd.va.gov/professional/treat/cooccurring/ptsd_physical_health.asp

Trauma, PTSD, and Physical Health Several studies have shown improvements in self-reported health symptoms following trauma-focused treatment for PTSD (e.g. 37-39) and on functioning (40,41).

8. sciencedirect.com sciencedirect.com/science/article/pii/S266675682500039X

Post-traumatic stress disorder in older adults: a global ... In this Personal View, we review the current state of research on PTSD and ageing, as presented by the On Traumatic Stress and Ageing: A Global Network task ...

9. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1151248/full

Work-related posttraumatic stress disorder in paramedics ... Pooled 12-month prevalence estimates of PTSD were 20.0, 3.1, 15.6, and 12.0%, respectively. Prevalence estimates in paramedics varied with ...