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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test a brief, new psychotherapy (called Positive Processes and Transition to Health - Single Session, or PATH-SS) that aims to provide relief for people who are suffering after experiencing a sexual assault. This research will explore whether this new psychotherapy reduces sexual assault related distress, including posttraumatic stress and depression symptoms. The main questions it aims to answer are: Does PATH-SS leads to improvements in PTSD and depression symptoms (pre- to post- and 1-month follow-up)? Do participants perceive PATH-SS to be acceptable, helpful, and do they complete/adhere to treatment? Participants will complete a pre-treatment/baseline assessment to confirm eligibility, and those who are eligible will receive the single-session intervention and will complete a post-treatment and a 1-month follow-up assessment of stressor-related symptoms.

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 safety data exists for the treatment PATH-SS for PTSD?

The research highlights the importance of accurately reporting adverse events (unintended signs or symptoms) in clinical trials, especially for psychological treatments. However, it does not provide specific safety data for PATH-SS, indicating a need for more standardized and comprehensive safety assessments in such studies. ^{1 2 3 4 5}

Research Team

Norah C Feeny, PhD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

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

I am currently diagnosed with severe depression or bipolar disorder.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

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

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. [2023]

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

The Mental Health Trigger Tool: Development and Testing of a Specialized Trigger Tool for Mental Health Settings. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Editorial: Primum non nocere - are adverse events accurately reported in studies on psychological interventions for children? [2023]

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

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. [2023]