Knaevelsrud 2015.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Sample size: 159 Diagnosis: DSM‐IV PTSD Method of recruitment: advertisements and presentations at department of defence sites Method of diagnosis: PDS used to identify if participants reported the minimum number of symptoms required by DSM‐IV for each of the symptom clusters (at least 1 intrusion, 3 avoidance, and 2 hyperarousal symptoms). Minimum score of 11 on the PDS required. Trauma type: war related Age (mean): interapy: 29.11 (SD 8.20) years; wait list: 27.15 (SD 6.48) years Sex: interapy: 60 women (79%); wait list: 55 women (69%) Location: Iraq Comorbidities: unclear Adjunctive therapy: excluded Adjunctive medication: unclear Unemployment: interapy: 26 (33%); wait list: 29 (36%) University education: interapy: 56 (71%); wait list: 38 (48%) Exclusion criteria: currently receiving treatment elsewhere; substance abuse or dependence; high risk of suicide; psychotic symptoms; low symptom severity Baseline PDS scores (mean): interapy: 30.87 (SD 8.13); wait list: 31.81 (SD 7.13) |
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Interventions |
Internet programme based on trauma‐focused CBT versus wait list Experimental arm Interapy Duration: 5 weeks Treatment protocol
Type of contact: short homework reminder by e‐mail, if no response contacted by phone; exact method of communication unclear. Automated contact: unknown, not reported Type of therapist: native speaking psychotherapists Treatment fidelity: weekly supervision sessions, either face‐to‐face or via Skype Comparator arm Duration: 6 weeks Treatment protocol: participants were on a wait list for 6 weeks and then received the intervention. Therapist contact: none |
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Outcomes | PDS; HSCL‐25; EUROHIS‐QUOL | |
Notes | Funding source: unclear Declarations of interest among the primary researchers: unclear |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomisation was based on a computer‐generated randomisation list." |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "researchers and psychotherapists were not masked to the intervention." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: self‐reported measures |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT analysis BUT missing data > 30% |
Selective reporting (reporting bias) | Low risk | Study protocol available (Registered Trial (p.2) – Australian New Zealand Clinical Trial Registry) and the published reports included all expected outcomes, including those that were prespecified. |
Other bias | Low risk | Study appeared free from other sources of bias. |