| Study characteristics |
| Methods |
Study design: randomised controlled trial
Study grouping: parallel group
Duration of study: May 2012 to August 2014
Ethics approvals: approval from 4 IRBs at the universities and colleges where recruitment took place
Location of study: 4 US universities and community colleges, including East Carolina
Randomisation method: participants were randomised to the interactive programme or psychoeducational website based on a computerised coin flip. |
| Participants |
Baseline characteristics
CBT (CBT‐online)
Participants (at randomisation): 46 Gender: 100% female participants Age: not given Ethnicity: 41.3% white, 21.7% Black, 38.3% other Disability: not given Time since trauma: not given Income: not given Education (% high school, college or apprentice, university or years of education): all college students Employment: not given Sexual violence in adulthood: 100% Comorbid conditions: not given Baseline PTSD, M (SD): 23.7 (6.5) Partnered: not given Randomised (N): 46 Completed post‐treatment assessment (N): 26 Dropped out or removed prior to analysis (N): 24 Numbers analysed at final applicable time point (N): 22 Number of sessions: not given Treatment completion: 26 (57%)
Minimal intervention (psychoeducation website)
Participants (select at randomisation if available): 41 Gender: 100% female participants Age: not given Ethnicity: 51.2% white, 29.3% Black, 14.6% other Disability: not given Time since trauma: not given Income: not given Education (% high school, college or apprentice, university or years of education): all college students Employment: not given Sexual violence in adulthood: 100% Comorbid conditions: not given Baseline PTSD, M (SD): 23 (7.3) Partnered: not given Randomised (N): 41 Completed post‐treatment assessment (N): 29 Dropped out or removed prior to analysis (N): 20 Numbers analysed at final applicable time point (N): 21 Number of sessions: not given Treatment completion: 29 (71%)
Overall
Participants (at randomisation): 87 Gender: 100% female participants Age, M (range): 22 years (18 years to 42 years) Ethnicity: 46% white, 25.3% Black, 20.7% other Disability: not given Time since trauma, M: < 4 years Income: not given Education (% high school, college or apprentice, university or years of education): all college students Employment: not given Sexual violence in adulthood: 100% Comorbid conditions: 56.2% Baseline PTSD: not given Partnered: not given Approached (N): 150 Ineligible (N): 60 Declined (N): 4 Other (N): 1 Randomised (N): 87 Completed post‐treatment assessment (N): 55 Dropped out or removed prior to analysis (N): 44 Numbers analysed at final applicable time point (N): 43
Inclusion criteria
Participants had to have experienced a completed rape since the age of 14 years. Participants had to have a PTSD diagnosis determined using the PSS‐I (Foa 1993). Regular access to a computer and a telephone number at which they could be reliably reached Currently a student enrolled at one of the universities involved in the study
Exclusion criteria
Currently receiving psychotherapy Lack of stability on psychotropic medication (not been on current medication and dosage for at least 3 months) Active suicidality as determined by interview utilising the Scale for Suicidal Ideation (Beck 1979) Meeting DSM‐IV criteria for current substance dependence assessed with substance use disorder module of Structured Clinical Interview for the DSM‐IV Too acutely distressed to participate
Pretreatment: none identified, with the exception that women assigned to the interactive programme were more likely to report that the perpetrator used severe force |
| Interventions |
Intervention characteristics
CBT (online)
Planned number of intervention sessions: 9 Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): online with feedback from therapist on exercises Format (group, individual, blend): individual Therapist qualifications and training appropriate (yes, no, unclear, with explanation): unclear, study staff are referred to as doctoral clinical psychology students or postdoctoral fellows, but training not specified Research allegiance or conflict of interest (yes, no, unclear, with explanation): unclear, but presume they have developed the online programme Treatment fidelity (yes, no, unclear, with explanation): yes, external raters reviewed therapeutic feedback provided to participants, which was "uniformly high", although unclear who they are or against what criteria Intervention aim and theoretical basis: Survivor to Thriver Program consists of sequential modules, focusing on psychoeducation in modules 1 to 3; modules 4 and 5 introduce the cognitive model, teaching participants to identify distorted and unhelpful thoughts; the third phase focused on using a number of CBT techniques to address specific concerns among women following sexual assault. Duration of intervention: 14 weeks
Minimal intervention (psychoeducation website)
Planned number of intervention sessions: 3; identical to Sessions 1 to 3 in other arm Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): online 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 psychoeducational website contained the written content of the first 3 modules of the interactive programme, including the symptoms of PTSD, information about relaxing and grounding and information about healthy coping strategies. Duration of intervention: 14 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
Depression
Outcome type: continuous outcome Scale used: CES‐D Direction: lower is better Score range: 0 to 60 Data value: endpoint, 3 months
Anxiety
Outcome type: continuous outcome Scale used: Four‐Dimensional Anxiety Scale Direction: lower is better Score range: 35 to 175 Data value: endpoint, 3 months
Adverse events
Outcome type: continuous outcome Notes: adverse events – 2 in interactive programme and 1 in psychoeducational arm had increased depressive symptoms; 1 participant in interactive programme had increased anxiety at follow‐up.
Treatment dropout
|
| Identification |
Sponsorship source: the research was supported by funding from the NIMH grant number 1R34MH085118.
Country: USA
Setting: university students with rape‐related PTSD; online therapy
Authors name: Heather Littleton
Institution: East Carolina University
Email: hlittlet@uccs.edu
Year: 2017 |
| Notes |
Numbers in population characteristics are at randomisation. Number approached less ineligible is out by 1, so we added 1 to the 'Other' category.
Included in meta‐analysis |
