Litz 2007.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Sample size: 45 Diagnosis: DSM‐IV PTSD Method of recruitment: advertisements and presentations at department of defence sites Method of diagnosis: PSS‐I Trauma type: combat exposure: 9/11 attack on the Pentagon, or combat in Iraq or Afghanistan Age (mean): Internet CBT: 38.63 (SD 9.41) years; Internet supportive counselling: 39.86 (SD 7.72) years Sex: unclear Location: US Comorbidities: unclear Adjunctive therapy: excluded Adjunctive medication: unclear Unemployment: unclear University education: unclear Exclusion criteria: active substance dependence; current suicidal ideation; history of psychotic disorder; aged < 21 or > 65 years; PTSD or depression immediately before the trauma; current psychiatric treatment; marked ongoing stressors; inadequate social supports; change in medication. Baseline PTSD: all participants met diagnostic criteria for PTSD. Baseline PSS‐I scores: Internet CBT: 26.71 (SD 9.02); Internet supportive counselling: 29.16 (SD 9.93) |
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Interventions |
Internet programme based on trauma‐focused CBT with Internet psychological therapy (non‐CBT) Experimental arm Duration: 8 weeks Treatment protocol
Therapist contact: initial face‐to‐face (2 hours, including baseline assessment); telephone (ad‐lib); e‐mail (ad‐lib) Type of contact: online, e‐mail, face‐to‐face Automated contact: none Type of therapist: unclear Treatment fidelity: not reported Comparator arm Duration: 8 weeks Treatment protocol
Therapist contact: initial face‐to‐face (2 hours, including baseline assessment), telephone (ad‐lib), e‐mail (ad‐lib) Type of contact: online, e‐mail, face‐to‐face Automated contact: none Type of therapist: unclear |
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Outcomes | Time points for assessment: pretreatment, post‐treatment, 3‐month follow‐up, and 6‐month follow‐up Primary outcome: PSS‐I Secondary outcome: BDI, BAI |
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Notes | Funding source: supported by grant from NIHM (MH66589) 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 | Not reported |
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 | Quote: "The study therapists conducted the baseline assessments in order to initially establish rapport. Clinicians blind to study arm conducted the follow‐up evaluations." |
Incomplete outcome data (attrition bias) All outcomes | High risk | Authors stated that they performed ITT analyses, but only completer analyses were reported. |
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 | Small sample size Large numbers lost to 3‐month follow‐up and 6‐month follow‐up. Evaluated by the originators of the intervention. |