Walsh 2017.

Study characteristics
Methods	Study design: randomised controlled trial Study grouping: parallel group Duration of study: recruitment May 2009 to December 2013 Ethics approvals: all procedures were approved by 2 university and 2 affiliated hospital IRBs Location of study: Midwestern USA Randomisation method: the study was designed as a parallel trial with an allocation ratio of 1:1:1. A computerised random numbers generator was used to randomly assign participants to 1 of 3 conditions via a stratified blocked randomisation procedure with variable block sizes of 9 or 12. Nurses who enrolled participants immediately after the study commenced (phase 1) accessed videos for participants via a secure internet link and administered videos prior to the medical examination. Following an approved change of scope, those enrolled in phase 2 (n = 126) were administered videos on CDs following the medical examination that were stored in envelopes prepared by a study coordinator and labelled only with a participant number until opened by the nurse, who was blind to study condition to that point.
Participants	Baseline characteristics Other psychosocial interventions (prevention of post‐rape stress video) Participants (completers/assessed): 54 Gender: 100% female participants Age, M (SD): 26.79 years (8.22 years) Ethnicity: 66.7% minority status Disability: not given Time since trauma, M: < 7 d Income: 84.8% < USD 25,000; 10.9% USD 25,000 to USD 50,000; 4.3% > USD 50,000 Education (% high school, college or apprentice, university or years of education): 27.8% less than high school; 59.3% high school diploma, some college or both; 13% college degree Employment (% employed, unemployed, other): 33.3% employed; 11.1% student Sexual violence in adulthood: 96.1% Comorbid conditions: 50% past‐year binge‐drinking; 42.6% past‐year marijuana use Baseline PTSD: not given Partnered: 16.7% Randomised (N): 82 Completed post‐treatment assessment (N): 54 Dropped out or removed prior to analysis (N): 44 Numbers analysed at final applicable time point (N): 38 Number of sessions, M: 1 Treatment completion: 77 (94%) Behavioural (relaxation video) Participants (completers/assessed): 48 Gender: 100% female participants Age, M (SD): 27.99 years (10.77 years) Ethnicity: 53.8% minority status Disability: not given Time since trauma, M: < 7 d Income: 78.3% < USD 25,000; 19.6% USD 25,000 to USD 50,000; 2.2% > USD 50,000 Education (% high school, college or apprentice, university or years of education): 22.9% less than high school; 66.7% high school diploma, some college or both; 10.4% college degree Employment (% employed; unemployed, other): 34.4% employed; 10.4% student Sexual violence in adulthood: 93.5% Comorbid conditions: 48.1% past‐year binge‐drinking; 51.9% past‐year marijuana use Baseline PTSD: not given Partnered: 10.4% Randomised (N): 82 Completed post‐treatment assessment (N): 48 Dropped out or removed prior to analysis (N): 41 Numbers analysed at final applicable time point (N): 41 Number of sessions, M: 1 Treatment completion: 77 (94%) Usual care Participants (completers/assessed): 52 Gender: 100% female participants Age, M (SD): 27.52 years (10.01 years) Ethnicity: 50.0% minority status Disability: not given Time since trauma, M: < 7 d Income: 88.9% < USD 25,000; 6.7% USD 25,000 to USD 50,000; 4.4% > USD 50,000 Education (% high school, college or apprentice, university or years of education): 17.3% less than high school; 78.8% high school diploma, some college or both; 3.8% college degree Employment (% employed, unemployed, other): 34.6% employed; 19.2% student Sexual violence in adulthood: 97.5% Comorbid conditions: 33.3% past‐year binge‐drinking; 45.8% past‐year marijuana Baseline PTSD: not given Partnered: 13.5% Randomised (N): 81 Completed post‐treatment assessment (N): 52 Dropped out or removed prior to analysis (N): 39 Numbers analysed at final applicable time point (N): 42 Overall Participants (completers/assessed): 154 Gender: 100% female participants Age, M (SD): 27.53 years (9.7 years) Ethnicity: 42.9% white; 29.2% Black/African American; 11% Hispanic/Latina, 9.7% multiracial; 7.1% Native American Disability: not given Time since trauma, M: < 7 d Income: 83.9% < USD 25,000; 12.4% USD 25,000 to USD 50,000; 3.6% > USD 50,000 Education (% high school, college or apprentice, university or years of education): 22.7% less than high school; 68.2% high school diploma, some college or both; 9.1% college degree Employment (% employed, unemployed, other): 34.4% employed; 13.6% student Sexual violence in adulthood: 95.7% sexual violence in adulthood and 62% had a prior sexual assault Comorbid conditions: 44.2% past‐year binge‐drinking; 46.8% past‐year marijuana use Baseline PTSD: not given Partnered: 13.6% Approached (N): 711 Ineligible (N): 231 Declined (N): 209 Other (N): 26 Randomised (N): 245 Completed post‐treatment assessment (N): 154 Dropout/removed prior to analysis (N): 124 Numbers analysed at final applicable time point (N): 121 Inclusion criteria Girls and women 15 years or older who were recent victims of sexual assault (rape, suspected rape or attempted rape) Had a sexual assault medical and forensic examination within 7 d of assault Exclusion criteria Non‐English‐speaking Presented with serious injuries or medical issues, psychological distress, acute intoxication or other factors that would preclude participating in informed consent procedures Pretreatment: none reported
Interventions	Intervention characteristics Other psychosocial interventions (prevention of post‐rape stress video) Planned number of intervention sessions: 1 Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): video Format (group, individual, blend): individual Therapist qualifications and training appropriate: N/A Research allegiance or conflict of interest (yes, no, unclear, with explanation): unclear, authors seem to have developed the video. Treatment fidelity (yes, no, unclear, with explanation): yes, video consistently delivers same content. Intervention aim and theoretical basis: this 9‐minute video entitled Steps to Recovery included a female narrator providing information that could be used by victims to prevent future emotional problems and substance abuse, such as instructions for proper implementation of self‐directed exposure exercises, methods to recognise and terminate inappropriate avoidance, and strategies to engage in activities that specifically did not involve alcohol or drug use and avoid situations or cues that have been triggers for use. Video included information, psychoeducation and modelling of adaptive behavioural coping strategies for use post‐assault. Duration of intervention: 1 session in the ED Behavioural (relaxation video) Planned number of intervention sessions: 1 Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): video Format (group, individual, blend): individual Therapist qualifications and training appropriate: N/A Research allegiance or conflict of interest (yes, no, unclear, with explanation): no Treatment fidelity (yes, no, unclear, with explanation): yes, video consistently delivers same content Intervention aim and theoretical basis: this active control is a 9‐minute video that included a female narrator providing instructions in diaphragmatic breathing, use of words such as 'relax' paired with exhalation, instructions regarding muscle relaxation, and pleasant nature‐related imagery and sounds. The original DVD was a commercial product entitled Relax© (David Garrigus Productions) that was edited for content and length. Duration of intervention: 1 session in the ED Usual care Planned number of intervention sessions: N/A Mode of delivery: N/A Format: N/A Therapist qualifications and training appropriate: N/A Research allegiance or conflict of interest: N/A Treatment fidelity: N/A Intervention aim and theoretical basis: N/A Duration of intervention: N/A
Outcomes	PTSD Outcome type: continuous outcome Scale used: PSS‐SR Direction: lower is better Score range: 0 to 119 Data value: endpoint Substance use Outcome type: continuous outcome Scale used: DAST Direction: lower is better Score range: 0 to 28 Data value: endpoint Substance use Outcome type: continuous outcome Scale used: AUDIT Direction: lower is better Score range: 0 to 40 Data value: endpoint Adverse events Outcome type: adverse event Treatment dropout Outcome type: dichotomous outcome
Identification	Sponsorship source: the study was conducted with support from National Institute on Drug Abuse grant DA023099. Manuscript preparation was supported by National Institutes of Health grants MH107641, MH107641‐02S1, DA036213 and T32‐MH018869. Trial registered at clinicaltrials.gov under the registration number NCT01430624 Country: USA Setting: 2 medical centres (acute) providing post‐sexual assault medical forensic examinations Authors name: Kate Walsh Institution: Yeshiva University Email: kate.walsh@einstein.yu.edu Year: 2017
Notes	No baseline data, and we treated the 6‐week data as post‐treatment; population characteristics by the groups N included in final analysis (n = 154). PTSD data taken from trial registry https://clinicaltrials.gov/ct2/show/results/NCT01430624 Included in meta‐analysis Communicated with the author(s) for purposes of the research

AC: Assessment Control; ADIS‐R: Anxiety Disorders Interview Schedule‐Revised; ART: antiretroviral therapy; ASI: Addiction Severity Index; AUD: Australian dollar; AUDIT: Alcohol Use Disorders Identification Test; BA: Bachelor of Arts degree; BAI: Beck Anxiety Inventory; BDI: Beck Depression Inventory; BS: Bachelor of Science degree; BSI: Brief Symptom Inventory; CAPS: Clinician‐Administered PTSD Scale; CAPS‐5: Clinician‐Administered PTSD Scale for DSM‐5; CBT: cognitive behavioural therapy; CES‐D: Center for Epidemiologic Studies Depression Scale; CI: confidence interval; CPT: cognitive processing therapy; CR: cognitive restructuring; CTSA: Center for the Treatment and Study of Anxiety; DAST: Drug Abuse Screening Test; DSM‐III‐R: Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; DSM‐5: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; ED: emergency department; EMDR: eye movement desensitisation and reprocessing; HADS: Hospital Anxiety and Depression Scale; HBT: home‐based telemedicine; HIPAA: Health Insurance Portability and Accountability Act; HRV: heart rate variability; HRVB: heart rate variability biofeedback; IES‐R: Impact of Event Scale – Revised; ImpACT: improving AIDS care after trauma IRB: institutional review board; IRC: International Rescue Committee; IRT: image rehearsal therapy; ITT: intention‐to‐treat; KTA: Karolinska Trial Alliance; LI: Lifespan Integration; LZNF: low‐resolution electromagnetic tomography Z score neurofeedback; M: mean; M‐CET: multiple‐channel exposure therapy; MLI: Modified Lifespan Integration; MPSS‐SR: Modified PTSD Symptom Scale – Self‐Report; MST: military sexual trauma; N/A: not applicable; NEIRB: New England Independent Review Board; NET: narrative exposure therapy; NIMH: National Institute of Mental Health; PAOS: Postacademisch Onderwijs in de Sociale Wetenschappen; PBRS: Pediatric Behavior Rating Scale; PCL‐5: Post‐traumatic Stress Disorder Checklist for DSM‐5 criteria; PCL‐C: Post‐traumatic Stress Disorder Checklist for DSM‐5 criteria – Civilian version; PCT: present‐centred therapy; PDS‐I: Posttraumatic Diagnostic Scale; PDS‐I: Posttraumatic Diagnostic Scale – Interview; PE: prolonged exposure; PEP: postexposure prophylaxis; PI: principal investigator; PhD: Doctor of Philosophy; PSS‐I: PTSD Symptom Scale – Interview; PSS‐SR: PTSD Symptom Scale – Self‐Report; PTCI: Post‐traumatic Cognitions Inventory; PTSD: post‐traumatic stress disorder; QOLI: Quality of Life Inventory; RAST: Rape Aftermath Symptom Test; REDCap: Research Electronic Data Capture; RTM: reconsolidation of traumatic memories; SANE: sexual assault nurse examiner; SC: supportive counselling; SD: standard deviation; SF‐36: 36‐item Short‐Form Health Survey; SHE: Safe and Healthy Experiences programme; SIT: stress inoculation therapy; SoC: standard of care; ssmCPT: sleep and symptom monitoring; SSS: Symptom Severity Score; STAI: State‐Trait Anxiety Inventory; SUDs: subjective units of discomfort scale; TAU: treatment as usual; TCTSY: trauma centre trauma‐sensitive yoga; TRGI: Trauma‐Related Guilt Inventory; USD: US dollar; VA: Veterans Affairs; VSLA: Village Savings and Loans Associations; WHO: World Health Organization; WOAR: Women Organized Against Rape; WONSA: World of No Sexual Abuse