Spence 2011.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Sample size: 42 Diagnosis: DSM‐IV PTSD Method of recruitment: recruitment from a website that offers participation in trials, adverts in local media. Method of diagnosis: MINI administered via telephone Trauma type: various Age (mean): I‐CBT: 43.0 (SD 15.2) years; wait list: 42.0 (SD 10.4) years Sex: 81% women; 19% men Location: Australia Comorbidities: unclear Adjunctive therapy: excluded Adjunctive medication: stable for 1 month Unemployment: 40% University education: unclear Exclusion criteria: currently experiencing a psychotic mental illness; severe symptoms of depression; currently highly dissociative; current CBT. Baseline PTSD: all participants met diagnostic criteria for PTSD. Baseline PCL‐C scores (mean): I‐CBT: 60.78 (SD 10.03); wait list: 57.00 (SD 9.69) |
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Interventions |
Internet programme based on trauma‐focused CBT versus wait list Experimental arm Duration: 8 weeks Treatment protocol
Therapist contact (mean): 103.91 (SD 96.53) minutes Type of contact: telephone, e‐mail, forum Automated contact: reminders and notifications Type of therapist: clinical psychologist Treatment fidelity: not reported Comparator arm Duration: 8 weeks Treatment protocol: wait list |
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Outcomes | Time points for assessment: pretreatment, post‐treatment, and 3‐month follow‐up Primary outcome: PCL‐C Secondary outcome: PHQ‐9, GAD‐7, SDS |
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Notes | Funding source: supported by a research fellowship from the New South Wales Institute of Psychiatry. Declarations of interest among the primary researchers: contract grant sponsor: New South Wales Institute of Psychiatry |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Forty‐four applicants met all inclusion criteria and were randomized via a true randomization process (www.random.org), generated by an independent person." |
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: "Treatment group participants had a similar diagnostic assessment at three‐month follow‐up. These assessments were conducted by JS and KS, who were not blind to the participants’ condition." |
Incomplete outcome data (attrition bias) All outcomes | High risk | ITT analyses using LOCF. |
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 | Unclear risk | Small sample size Recruitment ceased after 4 weeks due to staff availability. Did not meet the recruitment target (indicated by power calculation) of 26 per group. Evaluated by the originators of the intervention. Time‐since‐trauma not recorded, so unsure about the requirement for the trauma to have been at least 1 month previously. |
AUDIT: Alcohol Use Disorders Identification Test; BAI: Beck Anxiety Inventory; BDI‐II: Beck Depression Inventory II; B‐IPF: Brief‐Inventory of Psychosocial Functioning; CAPS: Clinician Administered PTSD Scale; CBT: cognitive behavioural therapy; CES‐D: Center for Epidemiologic Studies Depression Scale; CGI‐I: Clinical Global Impressions – Improvement; DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders; FDAS: Food & Drug Analytical Services; GAD‐7: Generalized Anxiety Disorder 7; HSCL‐25: ; I‐CBT: Internet‐based cognitive behavioural therapy; IES‐R: Impact of Event Scale – Revised; ITT: intention to treat; LOCF: last observation carried forward; MINI: Mini‐International Neuropsychiatric Interview; PCL: PTSD Checklist; PCL‐C: PTSD Checklist – Civilian Version; PCL‐M: PTSD Checklist – Military Version; PDS: Posttraumatic Diagnostic Scale; PHQ‐9: Patient Health Questionnaire‐9; PSS‐I: PTSD Symptom Scale – Interview; PTSD: post‐traumatic stress disorder; QOLI: Quality of Life Inventory; SD: standard deviation; SDS: Shehan Disability Scale; SSQ: Social Support Questionnaire; TAU: treatment as usual; WIRED: Warriors Internet Recovery & EDucation.