| Participants |
Baseline characteristics
CBT (CPT)
Participants (at randomisation): 56 Gender: 100% female participants Age: not given Ethnicity: not given Disability: not given Time since trauma: not given Income: 79% < USD 20,000 Education: not given Employment: not given Sexual violence in adulthood: not given Comorbid conditions: not given Baseline PTSD, M (SD): 70.19 (15.5) Partnered: not given Randomised (N): 56 Completed post‐treatment assessment (N): 43 Dropped out or removed prior to analysis (N): 11 Numbers analysed at final applicable time point (N): 45 Number of sessions: not given Treatment completion: 27 (48%)
CBT (cognitive therapy)
Participants (select at randomisation if available): 51 Gender: 100% female participants Age: not given Ethnicity: not given Disability: not given Time since trauma: not given Income: 46% < USD 20,000 Education: not given Employment: not given Sexual violence in adulthood: not given Comorbid conditions: not given Baseline PTSD, M (SD): 73.87 (21.04) Partnered: not given Randomised (N): 51 Completed post‐treatment assessment (N): 38 Dropped out or removed prior to analysis (N): 15 Numbers analysed at final applicable time point (N): 36 Number of sessions: not given Treatment completion: 29 (57%)
CBT (written exposure)
Participants (at randomisation): 55 Gender: 100% female participants Age: not given Ethnicity: not given Disability: not given Time since trauma: not given Income: 42% < USD 20,000 Education: not given Employment: not given Sexual violence in adulthood: not given Comorbid conditions: not given Baseline PTSD, M (SD): 70.38 (18.65) Partnered: not given Randomised (N): 55 Completed post‐treatment assessment (N): 38 Dropped out or removed prior to analysis (N): 15 Numbers analysed at final applicable time point (N): 40 Number of sessions: not given Treatment completion: 30 (54%)
Overall
Participants (at randomisation): 162 Gender: 100% female participants Age, M (SD): 35.4 years (12.4 years) Ethnicity: 62% white, 34% African American, 4% other Disability: not given Time since trauma, M (SD): 175 months (174 months) Income: not given Education (% high school, college or apprentice, university or years of education): 13.8 years (2.8 years), 52% partial college or technical training Employment: not given Sexual violence in adulthood: 80.7% sexual violence in adulthood; 78% child sexual abuse; 60.7% domestic abuse; 84% adult physical assault Comorbid conditions: 50% current major depression; 20% panic disorder Baseline PTSD: not given Partnered: 20 Approached (N): 256 Ineligible (N): 75 Declined (N): 0 Other (N): 19 Randomised (N): 162 Completed post‐treatment assessment (N): 119 Dropped out or removed prior to analysis (N): 41 Numbers analysed at final applicable time point (N): 121
Inclusion criteria
Experienced sexual or physical assault in childhood or adulthood and met criteria for PTSD at the time of initial assessment At least 3 months post‐trauma (no upper limit) If taking medication, is stabilised Had been abstinent from substance use for 6 months, if had substance dependence Current users had to agree to desist from substance use during treatment.
Exclusion criteria
Pretreatment: CPT group had a significantly lower income than other 2 groups (cognitive therapy and written exposure/accounts). Lowest‐income participants were least likely to complete the full course of therapy. |
| Interventions |
Intervention characteristics
CBT (CPT)
Planned number of intervention sessions: 12 (12 × 60‐minute sessions) 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, therapists across arms were 8 women with either a doctorate or master's degree in clinical psychology and training in CBT. They were trained by Resick or another senior team member in the therapy required here; they had a manual, watched training videos and had practice sessions. They were supervised during the trial at weekly sessions. Research allegiance or conflict of interest (yes, no, unclear, with explanation): yes, first author developed the therapy. Treatment fidelity (yes, no, unclear, with explanation): yes, trained independent raters conducted assessment of treatment adherence and therapist competence. All sessions were recorded and available for random selection for assessment of fidelity. Ninety per cent of unique and essential elements were included in all sessions, and there were no violations of the protocols regarding proscribed elements. Intervention aim and theoretical basis: CPT followed the manual as written by Resick 1993. CPT is a highly structured protocol in which the client learns the skill of recognising and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others. Duration of intervention: 6 weeks
CBT (cognitive therapy)
Planned number of intervention sessions: 12 (12 × 60‐minute sessions) 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): as previous Treatment fidelity (yes, no, unclear, with explanation): as previous, and adherence for unique and essential elements was 90% adherence to the protocol across all sessions, and there were no protocol violations on proscribed elements. Intervention aim and theoretical basis: identical to CPT but without inclusion of the written account component Duration of intervention: 6 weeks
CBT (written exposure)
Planned number of intervention sessions: 7 (2 × 60‐minute sessions; 5 × 120 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): as previous Treatment fidelity (yes, no, unclear, with explanation): as previous, and for unique and essential elements on written accounts adherence, there was 80% adherence to the protocol across all sessions, and there were 2 violations on proscribed elements. Intervention aim and theoretical basis: included only the writing account component, although this has been expanded considerably to fit into a similar amount of therapy time Duration of intervention: 6 weeks
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