Ivarsson 2014.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Sample size: 62 Diagnosis: DSM‐IV PTSD Method of recruitment: adverts in local and national newspapers Method of diagnosis: CAPS by telephone Trauma type: various (apart from childhood abuse) Age (mean): immediate treatment: 44.8 (SD 11.2) years; delayed treatment: 47.2 (SD 12.2) years Sex: 82.3% women; 17.7% men Location: Sweden Comorbidities: no structured screening for comorbid conditions Adjunctive therapy: excluded Adjunctive medication: 25.8% (stable for 3 months) Unemployment: 8.1% University education: 56.5% Exclusion criteria: imminent suicide risk; concurrent psychological treatment; presence of alcohol abuse; ongoing trauma, or trauma within the past 3 months; symptoms following childhood abuse. Baseline PTSD: all participants met diagnostic criteria for PTSD. Baseline IES‐R Scores (mean): immediate treatment: 54.65 (SD 13.16); delayed treatment: 54.87 (SD 15.48) |
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Interventions |
Internet programme based on trauma‐focused CBT versus treatment as usual Experimental arm Duration: 8 weeks Treatment protocol
Therapist contact: once a week and occasional reminders via website. Type of contact: encrypted web‐service Automated contact: none Type of therapist: clinical psychology students (towards the end of course) Treatment fidelity: weekly supervision with an experienced clinical psychologist to monitor fidelity Comparator arm Duration: 8 weeks Participants in treatment group who did not finish all modules within 8 weeks were able to continue using the website without therapist support after post‐treatment data had been collected. Treatment protocol
Therapist contact: kept to a minimum. Therapist screened responses for suicidal ideation and was available to answer questions on the trial. |
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Outcomes | Time points for assessment: pretreatment, post‐treatment, 1‐year follow‐up Primary outcome: IES‐R, PDS Secondary outcome: BDI‐II, BAI, QOLI, CGI‐I |
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Notes | Funding source: grant from Linköping University Declarations of interest among primary researchers: unclear |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was conducted by an individual who was not otherwise involved in the research project, using an online true random number service (www.random.org)." |
Allocation concealment (selection bias) | Unclear risk | Quote: "Randomization was conducted by an individual who was not otherwise involved in the research project, using an online true random number service (www.random.org)." |
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 | Low risk | Quote: "The post‐treatment interviewers were blind to participant status (i.e. treatment or control)." Blinding impossible at 1‐year follow‐up since there was no longer a control group. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All analyses, both the pre‐ to post‐treatment and the pre‐treatment to one year follow‐up analysis, made use of all available data from all randomized participants, following the principle of intention‐to‐treat. Prior to conducting primary analyses, the missing data assumption was tested by exploring associations between baseline characteristics and the presence of missing data." |
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 | High risk | Evaluated by the originators of the intervention. |