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. 2018 Dec 14;2018(12):CD011710. doi: 10.1002/14651858.CD011710.pub2

Kuhn 2017.

Study characteristics
Methods Randomised controlled trial
Participants Sample size: 120
Diagnosis: DSM‐IV PTSD
Method of recruitment: advertisements through fliers, media coverage, social media and websites (Craigslist)
Method of diagnosis: PCL‐C
Trauma type: various
Age (mean): PTSD Coach: 39.43 (SD 15.16) years; wait list: 39.12 (SD 14.08) years
Sex: 69.2% women, 30.8% men
Location: US
Comorbidities: not reported
Adjunctive therapy: not reported
Adjunctive medication: not reported
Unemployment: not reported
University education: 14.2%
Exclusion criteria: currently receiving treatment for PTSD
Baseline PTSD: all participants met diagnostic criteria for PTSD (no participant had a PCL score < 35).
Baseline PCL scores (mean): for PTSD Coach: 63.19 (SD 11.78); wait list: 60.59 (SD 10.24)
Interventions Internet programme based on trauma‐focused CBT versus wait list
Experimental arm
Duration: 12 weeks
Treatment protocol: PTSD Coach
PTSD Coach condition participants were instructed to download the app and use it however they would like in an attempt to mimic real use. They were e‐mailed links to the post‐treatment assessment 3 months later and follow‐up assessment 6 months.
Comparator arm
Duration: 12 weeks
Treatment protocol: wait list
Wait list participants received no intervention during the treatment period. After the post‐treatment assessment, they were told that the app being studied was PTSD Coach, that the app was available in the App Store and Google Play Store, and that they were now free to download and use it if they would like. They were e‐mailed links to the post‐treatment assessment 3 months later and follow‐up assessment 6 months.
Outcomes Time points for assessment: 3 and 6 months
Primary outcome: PCL
Secondary outcome: PTSD symptom coping self‐efficacy, PHQ‐8 and B‐IPF
Notes Funding source: not reported
Declarations of interest among the primary researchers: none
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomized to conditions by the study coordinator using adaptive randomization, with the probability of condition assignment changing based on the assignment of participants already in the trial using www.randomizer.com."
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 Low risk Comment: self‐reported measures.
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "Following the intent‐to‐treat principle, data from all randomized participants were analyzed, and multiple imputation was used to replace missing values, with 10 imputed data sets being generated."
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 free from other sources of bias.