Miner 2016.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Sample size: 49 Diagnosis: DSM‐IV PTSD Method of recruitment: advertisements through fliers and websites Method of diagnosis: PCL‐C Trauma type: various Age (mean): total: 45.7 (SD 13.9) years. Age range not reported by group. Sex: 81.6% women, 18.4% men Location: US Comorbidities: not reported Adjunctive therapy: not reported Adjunctive medication: not reported Unemployment: not reported University education: not reported Exclusion criteria: currently receiving treatment for PTSD Baseline PTSD: all participants met diagnostic criteria for PTSD (no participant had a PCL score lower than the recommended range (i.e. 30–35). Baseline PSS‐I scores (mean): Internet CBT: 63.00 (SD 11.28); wait list: 59.33 (SD 11.34) |
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Interventions |
Internet programme based on trauma‐focused CBT versus wait list Experimental arm Duration: 4 weeks Treatment protocol: PTSD Coach Participants given the app and instructed to use it however they would like for the following month. No specific training, instructions for use, or suggestions of how PTSD Coach might be helpful were provided in attempt to represent real‐world use. Participants completed the post‐condition assessment 1 month later. Comparator arm Duration: 4 weeks Treatment protocol: wait list No intervention over 1 month. Participants completed the post‐condition assessment 1 month later. Upon completion of the post‐condition assessment, participants received the PTSD Coach. |
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Outcomes | Time points for assessment: 4 weeks Primary outcome: PCL Secondary outcome: acceptability, feasibility |
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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) | Unclear risk | Quote: "Participants were randomly assigned with an equal chance." Comment: insufficient reporting of methods to determine risk of bias. |
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: all outcomes self‐reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "The condition (PTSD Coach vs. waitlist) by time (baseline and post condition) interaction was used to estimate an effect size and assess if there was significant differential change in PCL scores using intention‐to‐treat (ITT) and completer analyses. For the ITT analysis multiple imputation with 10 imputed data sets was used to replace missing PCL values at the post‐condition (n=5; 10.2%) and follow‐up (n=9; 18.4%) assessments and ranges and averages of statistics across these imputed datasets are presented." Comment: ITT analysis and missing data < 20%. |
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. |