Positive Processes and Transition to Health - Single-Session (PATH-SS)

Official title

A Novel, Single-Session Intervention for Sexual Assault-Related Psychopathology

Overview

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.

Detailed description

This study will be an open trial to determine if PATH-SS reduces stressor-related symptoms of PTSD and/or depression after sexual assault in a sample of 45 adults who have experienced a sexual assault. Potential participants will first undergo a pre-screening to assess for likelihood of eligibility. Participants who may be eligible will proceed to the pre-treatment/baseline assessment; those excluded will be given referrals.

After informed consent is obtained, participants will complete the pre-treatment/baseline assessment to confirm eligibility. The assessing clinician will consult with the PI before making eligibility decisions. Eligible participants will then receive one session of the PATH-SS intervention, lasting up to 2 hours.

Symptoms will be assessed pre-treatment, post-treatment, and at 1-month follow-up, with each assessment lasting approximately 1 hour. Participants will be compensated $20 via Amazon or Visa gift card for each assessment completed following treatment. Participants will not be compensated for the intervention session.

Interventions

• Behavioral PATH-SS
  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 emotion

Primary outcome measures

• PTSD Symptom Scale-Interview (PSS-I-5; Foa et al., 2016) [Time frame: From baseline to follow-up at 1 month after treatment completion]
• Quick Inventory of Depressive Symptomatology-Clinican Report (QIDS-C; Rush et al., 2003) [Time frame: From baseline to follow-up at 1 month after treatment completion]
• Post-traumatic Stress Diagnostic Scale (PDS-5; Foa et al., 2016) [Time frame: From baseline to follow-up at 1 month after treatment completion]
• Quick Inventory of Depressive Symptomatology Self-Report Version (QIDS-SR; Rush et al., 2003) [Time frame: From baseline to follow-up at 1 month after treatment completion]

Secondary outcome measures (7)

• Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995) [Time frame: From baseline to follow-up at 1 month after treatment completion]
• Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988) [Time frame: From baseline to follow-up at 1 month after treatment completion]
• Working Alliance Inventory - Short Revised (WAI-SR; Munder et al., 2010) [Time frame: Post-treatment assessment and follow-up at 1 month after treatment completion]
• Relative Distress and Cost-Benefit Questions (Cromer et al., 2006; DePrince & Freyd, 2004) [Time frame: Post-treatment assessment and follow-up at 1 month after treatment completion]
• Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1994; 2004) [Time frame: Post-treatment assessment and follow-up at 1 month after treatment completion]
• Treatment Credibility Scale (CS, Addis & Carpenter, 1999) [Time frame: Post-treatment assessment and follow-up at 1 month after treatment completion]
• Utility of Techniques Inventory (UTI; adapted from Foa et al., 2002; Bluett et al., 2014) [Time frame: Post-treatment assessment and follow-up at 1 month after treatment completion]

Eligibility criteria

Inclusion criteria

• Age range: from 18 to 65.
• Has experienced unwanted sexual contact or sexual assault with a minimum of 12 weeks since the event and a maximum of 5 years since the event.
• Residence in the state of Ohio.
• Elevated symptoms on either the Posttraumatic Diagnostic Scale (PDS-5) or the Quick Inventory of Depressive Symptomatology (QIDS-SR), at least moderate: 18 on PDS-5 (Foa et al., 2016) and/or 11 on QIDS (moderate depression severity; Rush et al., 2003), with symptoms persisting for 1 month or longer.

Exclusion criteria

• Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by DSM-5.
• Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
• Severe self-injurious behavior or suicide attempt within the previous three months.
• Currently engaged in cognitive behavioral psychotherapy.
• No clear memory of the event.
• Unstable dose of psychotropic medications in prior 3 months.
• Ongoing intimate relationship with the perpetrator.
• Current diagnosis of a substance use disorder (DSM-5).
• Residence outside the state of Ohio.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Case Western Reserve University — Cleveland

Identifiers

NCT: NCT06900712 · STUDY20240516

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗