PTSDPATH-SSNCT06900712
Positive Processes and Transition to Health - Single-Session (PATH-SS)
A study testing PATH-SS in people with PTSD and Depression, run by Case Western Reserve University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Depression
- What is being tested?
- PATH-SS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Ongoing intimate relationship with the perpetrator.
- Current diagnosis of a substance use disorder (DSM-5).
- Residence outside the state of Ohio.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Western Reserve University
Cleveland, Ohio, 44106
Norah C Feeny, PhD, 216-368-2695, ncf2@case.edu
Jenna M Bagley, MA, 216-800-8492, jmb534@case.edu
About this study
Official title: A Novel, Single-Session Intervention for Sexual Assault-Related Psychopathology
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.
Read the 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.
- Conditions
- PTSD, Depression
- Being tested
- PATH-SS
- Keywords
- ptsd, trauma, depression, stressor, posttraumatic stress
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PATH-SSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PATH-SS | Experimental | 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. Receives: Behavioral: PATH-SS |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptom Scale-Interview (PSS-I-5; Foa et al., 2016)
The PSS-I is a 24-item, state-of-the-art, psychometrically-validated interview used to assess DSM-5 criteria for PTSD and symptom severity. The PSS-I-5 includes 20 questions assessing symptom severity on a 5-point Likert scale (0 = not at all, 4 = six or more times a week/severe), and scores are calculated by summing responses, with higher scores indicating higher PTSD severity, as well as two questions assessing distress and interference and two questions assessing symptom onset and duration.
Measured: From baseline to follow-up at 1 month after treatment completion
Quick Inventory of Depressive Symptomatology-Clinican Report (QIDS-C; Rush et al., 2003)
The QIDS-C is a 16 item, state-of-the-art, psychometrically-validated interview used to assess depression. Items are rated on a 4-point scale with anchors that vary with the question (e.g., 0 = I do not feel sad, 3 = I feel sad nearly all of the time).
Measured: From baseline to follow-up at 1 month after treatment completion
Post-traumatic Stress Diagnostic Scale (PDS-5; Foa et al., 2016)
The PDS-5 is a 24-item self-report measure used to assess prior trauma exposure and subsequent PTSD symptoms in the past month. The PDS-5 uses a trauma screen to identify prior exposure to traumatic events and assesses the severity of DSM-5 PTSD symptoms related to the event causing the most distress. The PDS-5 includes 20 questions assessing symptom severity on a 5-point Likert scale (0 = not at all, 4 = six or more times a week/severe), and scores are calculated by summing responses, with higher scores indicating higher PTSD severity. The PDS-5 also includes two questions assessing distress and interference and two questions assessing symptom onset and duration.
Measured: 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)
The QIDS-SR is a 16-item self-report measure that assesses depression. Items are rated on a 4-point scale with anchors that vary with the question (e.g., 0 = I do not feel sad, 3 = I feel sad nearly all of the time).
Measured: From baseline to follow-up at 1 month after treatment completion
Secondary outcomes (7)
Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995)
The SHAPS is a 14-item self-report measuring the capacity to experience pleasure. On a four-point scale (1 = Strongly Agree to 4 = Strongly Disagree), varying statements are rated (e.g., "I would find pleasure in small things"; "I would find pleasure in a telephone call from a friend"). The measure has good convergent and discriminant validity and reflects a unidimensional construct of anhedonia (Leventhal et al., 2006; Nakonezny et al., 2010).
Measured: From baseline to follow-up at 1 month after treatment completion
Multidimensional Scale of Perceived Social Support (MSPSS; Zimet et al., 1988)
The MSPSS is a 12-item self-report measure that assesses an individual's perceived level of social support from family, friends, and significant others. Items are rated on 7-point Likert scale (1 = Very Strongly Disagree, 7 = Very Strongly Agree).
Measured: From baseline to follow-up at 1 month after treatment completion
Working Alliance Inventory - Short Revised (WAI-SR; Munder et al., 2010)
The WAI-SR is a refined measure of the therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. The WAI-SR demonstrated good psychometric properties in an initial validation in psychotherapy outpatients in the USA (Munder et al., 2010), as well as in subsequent studies with college students (e.g., Jeong et al., 2023).
Measured: 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)
Includes three questions measuring participants' experiences of relative distress and cost-benefit beliefs about the survey content: "Was completing study tasks related to the topic of unwanted sexual encounters more or less distressing than anticipated?"; "How important do you believe it is for psychologists to ask about unwanted sexual encounters in order to study the impact of them?"; and "Please consider both your experience completing study tasks related to the topic of unwanted sexual encounters, and your feelings about how important it is that we ask these questions. How good of an idea is it to include such tasks in psychology research?". Items are rated on a 5-point scale with anchors that vary with the question (e.g., 1 = much more distressing, 2 = somewhat more, 3= neutral, 4= somewhat less, and 5 = much less distressing).
Measured: Post-treatment assessment and follow-up at 1 month after treatment completion
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1994; 2004)
The CSQ-8 is an 8-item questionnaire used to assess satisfaction in mental health services (Sitzia, 1999). This tool includes a brief standardized scale with good psychometric properties that provides an overall assessment of satisfaction (Rush et al. 2008). An additional item was added to specifically assess single-session format of treatment.
Measured: Post-treatment assessment and follow-up at 1 month after treatment completion
Treatment Credibility Scale (CS, Addis & Carpenter, 1999)
The CS is a 6-item self-report questionnaire that was developed for the purpose of the present study to assess patients' perceptions of the credibility of the treatment they were being provided. Participants responded to each item by rat- ing the extent to which the treatment makes sense and is logical to them on a 5-point Likert-type scale ranging from 1 to 5. The six treatment credibility items are: (a) How credible do you think this therapy is? ("not at all credible" to "very credible"); (b) How logical does this therapy seem to you? ("not at all logical" to "very logical"); (c) How much do you trust this therapy to help you? ("not at all" to "very much"); (d) How credible does your therapist seem? ("not at all credible" to "very credible"); (e) How much do you trust your therapist to be able to help you? ("not at all" to "very much"); and (f) How knowledgeable does your therapist appear? ("not at all knowledgeable" to "very knowledgeable").
Measured: 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)
This measure consists of 8 items assessing adherence to and utility of skills/techniques taught in therapy. Items are rated on a 5-point Likert scale with anchors that vary with the question (e.g., 0 = Not at all, 4 = More than 10 times; 0 = Not at all helpful, 4 = Extremely helpful).
Measured: Post-treatment assessment and follow-up at 1 month after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start17 Jul 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norah Feeny, Case Western Reserve University
- Investigators
- Norah C Feeny, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900712
- Sponsor's protocol ID
- STUDY20240516
- Acronym
- PATH-SS
- Status last verified
- Apr 2026
- First submitted
- 11 Mar 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel, Single-Session Intervention for Sexual Assault-Related Psychopathology
- ClinicalTrials.gov ID
- NCT06900712
- Acronym / sponsor ID
- PATH-SS / STUDY20240516
- Conditions
- PTSD, Depression
- Keywords
- ptsd, trauma, depression, stressor, posttraumatic stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 28 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PATH-SS | Experimental | Behavioral: PATH-SSThis 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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PATH-SSThis 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. | Behavioural | PATH-SS |
Primary outcome
PTSD Symptom Scale-Interview (PSS-I-5; Foa et al., 2016)
Time frame: From baseline to follow-up at 1 month after treatment completion
The PSS-I is a 24-item, state-of-the-art, psychometrically-validated interview used to assess DSM-5 criteria for PTSD and symptom severity. The PSS-I-5 includes 20 questions assessing symptom severity on a 5-point Likert scale (0 = not at all, 4 = six or more times a week/severe), and scores are calculated by summing responses, with higher scores indicating higher PTSD severity, as well as two questions assessing distress and interference and two questions assessing symptom onset and duration.
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
The QIDS-C is a 16 item, state-of-the-art, psychometrically-validated interview used to assess depression. Items are rated on a 4-point scale with anchors that vary with the question (e.g., 0 = I do not feel sad, 3 = I feel sad nearly all of the time).
Post-traumatic Stress Diagnostic Scale (PDS-5; Foa et al., 2016)
Time frame: From baseline to follow-up at 1 month after treatment completion
The PDS-5 is a 24-item self-report measure used to assess prior trauma exposure and subsequent PTSD symptoms in the past month. The PDS-5 uses a trauma screen to identify prior exposure to traumatic events and assesses the severity of DSM-5 PTSD symptoms related to the event causing the most distress. The PDS-5 includes 20 questions assessing symptom severity on a 5-point Likert scale (0 = not at all, 4 = six or more times a week/severe), and scores are calculated by summing responses, with higher scores indicating higher PTSD severity. The PDS-5 also includes two questions assessing distress and interference and two questions assessing symptom onset and duration.
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
The QIDS-SR is a 16-item self-report measure that assesses depression. Items are rated on a 4-point scale with anchors that vary with the question (e.g., 0 = I do not feel sad, 3 = I feel sad nearly all of the time).
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Norah C Feeny, PhD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PATH-SS in people with PTSD and Depression, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norah Feeny, PhD ((216) 368-2695, ncf2@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptom Scale-Interview (PSS-I-5; Foa et al., 2016) (time frame: From baseline to follow-up at 1 month after treatment completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.