Littleton 2016.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Sample size: 87 Diagnosis: DSM‐IV PTSD Method of recruitment: advertisements at 4 universities/community colleges, including postings on university psychology department participant management websites, and via social media. Method of diagnosis: PSS‐SI Trauma type: rape Age (mean): 22 years (range 18–42 years) for whole sample Sex: 100% women Location: US Comorbidities: SUD excluded Adjunctive therapy: not reported Adjunctive medication: not reported Unemployment: not reported University education: all students Exclusion criteria: current psychotherapy; changes in psychotropic medication in past 3 months; active suicidality; DSM‐IV criteria for current substance dependence. Baseline PTSD: not reported Baseline PSS‐I scores (mean): From Survivor to Thriver: 11.2 (SD 5.8); psychoeducational website: 10.4 (SD 8.5) |
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Interventions |
Internet programme based on trauma‐focused CBT with Internet psychological therapy (non‐CBT) Experimental arm Duration: 14 weeks Treatment protocol: From Survivor to Thriver From Survivor to Thriver program consisted of 9 programme modules to be completed sequentially, 1 module at a time. The program had 3 phases. The first phase (modules 1–3) was designed to provide psychoeducation about PTSD and the impact of unwanted sex, as well as introduce general distress management strategies (i.e. relaxation, grounding) and healthy coping (e.g. asking others for help, setting an action plan) skills. The second phase (modules 4–5) introduced the cognitive model and taught participants to identify distorted and unhelpful automatic thoughts and utilise the challenging questions technique to respond to these thoughts. The third phase (modules 6–9) focused on using a number of cognitive behavioural techniques (e.g. the challenging questions technique, the pros and cons technique, behavioural experiments) to address specific concerns common among women following sexual assault (e.g. difficulties with trust, self‐blame for the assault). Each module contained several components, including: a video clip of the program developers discussing the topic covered in the module, a written description of the skills or techniques being introduced or utilised in the module, and, for modules 4–9, written examples of women modelling using the skills and techniques utilised in the module. The final program component included in all modules was the interactive exercises. These interactive exercises were designed either to help women think about the extent to which the particular issue raised in the module was a concern for them (e.g. the extent to which they blame themselves for the sexual assault) or to enable them to practice a described cognitive‐behavioural skill or technique and receive feedback on their practice. The interactive exercises were completed asynchronously, and were designed in a question and answer format. After a participant completed the interactive exercise, her program therapist then provided written feedback to each answer provided, as well as embedded a video message containing more extensive feedback on the interactive exercise page in the program. Therapist feedback focused on encouraging and praising participants for their effort, expressing empathy, encouraging continued program progress, socialising participants to the cognitive model, and providing assistance in challenging automatic thoughts, such as through further use of Socratic questioning. Comparator arm Duration: 14 weeks Treatment protocol: psychoeducational website The psychoeducational website contained the written informational content of the first 3 modules of the interactive program including the symptoms of PTSD, information about relaxation and grounding, and information about healthy coping strategies. The website did not contain any of the multimedia content (videos from the program developers, audio recorded relaxation exercises), or any interactive exercises. Women assigned to the psychoeducational website condition were given access to all the website content and instructed to log in to the program and utilise the content in whatever manner and however frequently they desired to do so over the course of the study. |
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Outcomes | Time points for assessment: 3 months Primary outcome: PSS‐I Secondary outcome: CES‐D, FDAS |
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Notes | Funding source: not reported Declarations of interest among the primary researchers: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were randomized to the interactive program or psychoeducational website based on a computerized coin flip." |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Impossible to blind participants or therapists. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "individuals completing pre‐, post‐ and follow‐up assessments were not blind to participants’ intervention condition." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "In addition, estimates of change from pre‐test to post‐test and follow‐up were estimated for all participants assigned to a program, an Intent to‐Treat (ITT) model. For the ITT analyses, post‐test and follow‐up data for participants who left the study was imputed using the R package. Twenty imputations were used with all outcome variables." |
Selective reporting (reporting bias) | Low risk | Study protocol not available but it was clear that the published reports included all expected outcomes, including those that were prespecified. |
Other bias | Low risk | Study appeared to be free from other sources of bias. |