| Study characteristics |
| Methods |
Study design: randomised controlled trial
Study grouping: parallel group
Duration of study: no recruitment timeframe stated: 4‐week intervention, with the last follow‐up at 12 months post‐intervention
Ethics approvals: not given
Location of study: Philadelphia, Pennsylvania, USA
Randomisation method: participants were randomly assigned to brief CBT or an assessment condition (no‐treatment control); 1 year into the study, the SC condition was added, and randomisation was adjusted accordingly to increase the probability of participants being assigned to the SC condition. |
| Participants |
Baseline characteristics
CBT (brief CBT)
Participants (at randomisation): 31 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: 77% Comorbid conditions: not given Baseline PTSD, M (SD): 34.03 (7.86) Partnered: not given Randomised (N): 31 Completed post‐treatment assessment (N): 22 Dropped out or removed prior to analysis (N): 9 Numbers analysed at final applicable time point (N): 22 Number of sessions: not given Treatment completion: 22 (71%)
Humanistic (SC)
Participants (select at randomisation if available): 29 Gender: 100% female participants Age: not given Ethnicity: not given Disability: not given Time since trauma in months: not given Income: not given Education: not given Employment: not given Sexual violence in adulthood: 38% Comorbid conditions: not given Baseline PTSD, M (SD): 35.07 (7.63) Partnered: not given Randomised (N): 29 Completed post‐treatment assessment (N): 24 Dropped out or removed prior to analysis (N): 5 Numbers analysed at final applicable time point (N): 24 Number of sessions: not given Treatment completion: 24 (82.8%)
Assessment control (AC)
Participants (at randomisation): 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: 73% Comorbid conditions: not given Baseline PTSD, M (SD): 33.17 (6.48) Partnered: not given Randomised (N): 30 Completed post‐treatment assessment (N): 20 Dropped out or removed prior to analysis (N): 10 Numbers analysed at final applicable time point (N): 20 Number of sessions: not given Treatment completion: 20 (66.7%)
Overall
Participants (randomisation): 90 Gender: 100% female participants Age, M (SD): 33.7 years (11.13 years) Ethnicity: 31.3% white, 62.7% Black, 6% other Disability: not given Time since trauma, M (SD): 20.5 d (range of 2 d to 46 d) Income: 27.2% > USD 30,000, 42.9% USD 10,000 to USD 30,000, 29.9% < USD 10,000 Education (% high school, college or apprentice, university or years of education): 36.5% high school education or less, 43.9% some technical school or college education, 4.9% college education Employment: not given Sexual violence in adulthood: 63% Comorbid conditions: not given Baseline PTSD: not given Partnered: 15% Approached: not given Ineligible: not given Declined: not given Other: not given Randomised (N): 90 Completed post‐treatment assessment (N): 66 Dropped out or removed prior to analysis (N): 24 Numbers analysed at final applicable time point (N): 66
Inclusion criteria
Exclusion criteria
Women who were assaulted by an intimate partner with whom they had an ongoing relationship Primary diagnoses of organic mental disorder, schizophrenia, bipolar disorder Current alcohol or drug dependence
Pretreatment: 77% of the brief CBT and 73% of the assessment condition reported an index trauma of sexual assault, but only 38% of the SC condition reported a sexual assault as the index trauma. |
| Interventions |
Intervention characteristics
CBT (brief CBT)
Planned number of intervention sessions: 4 × 2‐hour 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, masters‐ and doctoral‐level therapists who received ongoing supervision and followed manuals that specified guidelines for each session conducted the interventions. Research allegiance or conflict of interest (yes, no, unclear, with explanation): unclear, the study builds on Foa 1995 and there is clear expectation that brief CBT should be superior; however, there are several measures to reduce any risk of research allegiance. Treatment fidelity (yes, no, unclear, with explanation): yes, tapes of intervention sessions were reviewed in weekly supervision to ensure adherence. Intervention aim and theoretical basis: used cognitive behavioural procedures that have been found effective for alleviating chronic PTSD in assault survivors (Foa 1999; Foa 1991). These included 1) education about the normal reactions to assault; 2) breathing/relaxation training; 3) recounting the assault (imaginal exposure); 4) approaching feared, but safe, situations (in vivo exposure); and 5) CR. Duration of intervention: 4 weeks
Humanistic (SC)
Planned number of intervention sessions: 4 × 2‐hour 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): no Treatment fidelity (yes, no, unclear, with explanation): yes, tapes of intervention sessions were reviewed in weekly supervision to ensure adherence. Intervention aim and theoretical basis: intervention consisted of active listening only. Neither discussion of assault‐related symptoms nor procedures aimed at promoting processing of the traumatic event were implemented. Also differed from assessment condition as there as no focus on symptoms Duration of intervention: 4 weeks
Assessment control
Planned number of intervention sessions: 4 × 2‐hour 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: N/A Research allegiance or conflict of interest: N/A Treatment fidelity: N/A Intervention aim and theoretical basis: the AC condition consisted of 4 meetings weekly for 2 h each that focused on a thorough assessment of each of the PTSD symptoms and post‐assault functioning by a PTSD clinician. Duration of intervention: 4 weeks
|
| Outcomes |
PTSD
Outcome type: continuous outcome Scale used: PSS‐I Direction: lower is better Score range: 0 to 51 Data value: endpoint, 3 months and 12 months
PTSD
Outcome type: continuous outcome Scale used: PSS‐SR Direction: lower is better Score range: 0 to 119 Data value: endpoint, 3 months and 12 months
Depression
Outcome type: continuous outcome Scale used: BDI Direction: lower is better Score range: 0 to 63 Data value: endpoint, 3 months and 12 months
Anxiety
Outcome type: continuous outcome Scale used: BAI Direction: lower is better Score range: 0 to 63 Data value: endpoint, 3 months and 12 months
Treatment dropout
Trauma‐related beliefs
Outcome type: continuous outcome Scale used: PBRS‐self Direction: higher is better Score range: 0 to 6 Data value: endpoint, 12 months
|
| Identification |
Sponsorship source: NIMH grant MH42173
Country: USA
Setting: urban clinic for the treatment and study of anxiety; recruitment through EDs and other medical settings, police, victim agencies and media
Authors name: Edna Foa
Institution: University of Pennsylvania; University of Washington; Case Western Reserve University
Email: foa@mail.med.upenn.edu
Year: 2006 |
| Notes |
The SC arm was added later, and systematic differences in the prevalence of sexual trauma were identified. Therefore, this group has been omitted. Not an ITT analysis, as data were only collected at follow‐up from intervention completers
Included in meta‐analysis |
