| Participants |
Baseline characteristics
CBT (PE)
Participants (select at randomisation if available): 25 Gender: 100% female participants Age: not given Ethnicity: not given Disability: not given Time since trauma: not given Income: not given Education: not given Employment: not given Sexual violence in adulthood: not given Comorbid conditions: not given Baseline PTSD, M (SD): 29.28 (9.94) Partnered: not given Randomised (N): 25 Completed post‐treatment assessment (N): 23 Dropped out or removed prior to analysis (N): 9 Numbers analysed at final applicable time point (N): 16 Number of sessions: not given Treatment completion: 23 (92%)
CBT (PE + SIT)
Participants (select at randomisation if available): 30 Gender: 100% female participants Age: not given Ethnicity: not given Disability: not given Time since trauma: not given Income: not given Education: not given Employment: not given Sexual violence in adulthood: not given Comorbid conditions: not given Baseline PTSD, M (SD): 29.95 (6.97) Partnered: not given Randomised (N): 30 Completed post‐treatment assessment (N): 22 Dropped out or removed prior to analysis (N): 14 Numbers analysed at final applicable time point (N): 16 Number of sessions: not given Treatment completion: 22 (73%)
CBT (SIT)
Participants (select at randomisation if available): 26 Gender: 100% female participants Age: not given Ethnicity: not given Disability: not given Time since trauma: not given Income: not given Education: not given Employment: not given Sexual violence in adulthood: not given Comorbid conditions: not given Baseline PTSD, M (SD): 29.42 (9.69) Partnered: not given Randomised (N): 26 Completed post‐treatment assessment (N): 19 Dropped out or removed prior to analysis (N): 12 Numbers analysed at final applicable time point (N): 14 Number of sessions: not given Treatment completion: 19 (73%)
Wait‐list
Participants (select at randomisation if available): 15 Gender: 100% female participants Age: not given Ethnicity: not given Disability: not given Time since trauma: not given Income: not given Education: not given Employment: not given Sexual violence in adulthood: not given Comorbid conditions: not given Baseline PTSD, M (SD): 32.93 (5.89) Partnered: not given Randomised (N): 15 Completed post‐treatment assessment (N): 15 Dropped out or removed prior to analysis (N): 0 Numbers analysed at final applicable time point (N): 0 Number of sessions: N/A Treatment completion: N/A
Overall
Participants (select at randomisation if available): 96 Gender: 100% female participants Age, M (SD): 34.9 years (10.6 years) Ethnicity: 63% white, 36% Black Disability: not given Time since trauma: not given Income: household income < USD 10,000 for a third of the participants; 38% > USD 30,000 Education (% high school, college or apprentice, university or years of education): 10% some high school, 18% high school diplomas, 41% some college education, 31% bachelor's degrees or higher Employment (% employed; unemployed, other): most employed full‐time (46%) or part‐time (16%) Sexual violence in adulthood: 72% (69) victims of sexual violence as index trauma; 48% reported at least 1 physical or sexual assault in adulthood prior to the index trauma, and 48% reported at least 1 incident of childhood physical or sexual abuse Comorbid conditions: not given Baseline PTSD: not given Partnered: not given Approached (N): 117 Ineligible (N): 13 Declined (N): 0 Other (N): 8 Randomised (N): 96 Completed post‐treatment assessment (N): 79 Dropped out or removed prior to analysis (N): 35 Numbers analysed at final applicable time point (N): 46 Number of sessions: N/A Treatment completion: N/A
Inclusion criteria
Exclusion criteria
Current schizophrenia, bipolar disorder, organic mental disorder, alcohol or drug dependence, severe suicidal ideation Being in intimate relationship with assailant
Pretreatment: No significant differences in demographics or pretreatment measures of psychopathology. There was an observed trend towards group differences on employment status – 19% of PE participants were unemployed compared with 30% of SIT, 43% of PE‐SIT, and 8% of wait‐list participants. No pre‐ or post‐treatment differences were detected between victims of sexual (n = 69) and nonsexual assault (n = 27). |
| Interventions |
Intervention characteristics
CBT (PE)
Planned number of intervention sessions: 9 sessions totalling 14.5 h (2 sessions of 120 min + 7 sessions of 90 min) Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): face‐to‐face Format (group, individual, blend): individual Therapist qualifications and training appropriate (yes, no, unclear, with explanation): yes, PhD‐level clinical psychologists were trained to use manuals that specified precise treatment guidelines for each session and received ongoing supervision by EB Foa and CV Dancu. Research allegiance or conflict of interest (yes, no, unclear, with explanation): no Treatment fidelity (yes, no, unclear, with explanation): yes, in addition to precise treatment guidelines and regular supervision, 9% of sessions were videotaped and assessed for presence of 52 intervention components across the treatments. On average, therapists completed 93% (SD = 12%) of the components prescribed for a given session in the corresponding protocol Intervention aim and theoretical basis: to encourage clients to relive memories of the traumatic event (i.e. imaginal exposure) and confront situations that are avoided because they trigger distressing memories and thoughts. Based on description in Foa 1998, PE focused on reliving the traumatic event in imagination (i.e. imaginal exposure). Homework assignments consisted of in vivo exposure to objectively safe situations that caused anxiety or were avoided. Duration of intervention: 5 weeks
CBT (PE + SIT)
Planned number of intervention sessions: 9 sessions totalling 14.5 h (2 sessions of 120 min + 7 sessions of 90 min) Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): face‐to‐face Format (group, individual, blend): individual Therapist qualifications and training appropriate (yes, no, unclear, with explanation): as previous Research allegiance or conflict of interest (yes, no, unclear, with explanation): no Treatment fidelity (yes, no, unclear, with explanation): yes, as previous Intervention aim and theoretical basis: combination of PE and SIT elements as described, with the aim of demonstrating a superior outcome to either treatments alone Duration of intervention: 5 weeks
CBT (SIT)
Planned number of intervention sessions: 9 sessions totalling 14.5 h (2 sessions of 120 min + 7 sessions of 90 min) Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): face‐to‐face Format (group, individual, blend): individual Therapist qualifications and training appropriate (yes, no, unclear, with explanation): as previous Research allegiance or conflict of interest (yes, no, unclear, with explanation): no Treatment fidelity (yes, no, unclear, with explanation): yes, as previous; however, 1 insignificant deviation was observed Intervention aim and theoretical basis: to teach clients various coping strategies to manage trauma‐related anxiety (i.e. relaxation training, thought‐stopping, CR and positive self‐statements), adapted from Veronen 1983. SIT focused on anxiety management skills (i.e. breathing retraining, thought‐stopping, CR, positive affirmations and problem‐solving). SIT homework assignments consisted of assigned practice of the instructed coping skill. Duration of intervention: 5 weeks
Wait‐list
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: wait‐list ceased after 5 weeks
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