About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
PATH-SS
BehavioralThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
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.
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).
Secondary outcomes
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).
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).
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).
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).
Other outcomes
Demographics Questionnaire
The demographics questionnaire asks participants to provide information related to their age, sex and gender identity, sexual orientation, ethnicity, relationship status, and college year, (if applicable).
Treatment History Questionnaire (THQ)
This 4-item measure asks about current and past engagement in mental health services, respectively.
Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998)
The MINI is a brief, structured diagnostic interview used to screen for the major psychiatric disorders according to current diagnostic standards (e.g., the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \[DSM-5\]). Validation and reliability studies have been done comparing the MINI to the structured interviews developed by the American Psychiatric Assocaition and the World Health Organization (e.g., Amorim, 2000; Shields et al., 2021). The results of these studies show that the MINI has similarly high reliability and validity properties to both these instruments, but can be administered in a much shorter period of time (median administration time = 15 minutes).
Columbia-Suicide Severity Rating Scale (C-SSRS; Posner et al., 2008)
The C-SSRS will be administered by members of the study team (under the supervision of a licensed therapist) used to assess inclusion/exclusion criteria and monitor suicidality.
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