Fresco 2009.
| Methods | Design: RCT Conducted by the team who developed the intervention: yes |
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| Participants | Description: targeted Cut‐point for inclusion for indicated studies: N/A What risk was basis of inclusion for selected studies: scoring in the top percentile on the Expanded Attributional Style Questionnaire (Pessimism) Diagnostic interview to exclude those with current or previous depression: not undertaken Baseline severity of depression: BDI‐I: 9.4 (sub‐threshold) Mean age: 19.2 Age range: not specified Percentage male: 22.0% Setting: university State what psychiatric diagnoses were excluded: exclusion criteria not specified Suicide risk excluded: exclusion criteria not specified Parents with history of schizophrenia/bipolar disorder excluded: exclusion criteria not specified Country: USA |
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| Interventions | Broad category: CBT (for further information on intervention components, see Table 3) Manualised: yes Online: no Name of programme: Self Administered Optimism Training (SOT) Number of sessions: 1 session plus daily monitoring Length of sessions: 10 minute session plus daily monitoring of unclear duration Intensity (total number of hours): unclear Duration of treatment period: 28 days Group size: N/A as monitoring was individual‐based intervention Delivered by: unclear Fidelity: unclear if assessed Type of comparison: NT |
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| Outcomes | Diagnosis: N/A Name of self‐report depression measure: BDI‐I Name of clinician report depression measure: N/A Name of anxiety measure: N/A Name of general functioning measure: N/A Assessment points: post‐intervention |
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| Notes | Author contacted for methodological detail: no Author contacted for treatment manual: yes (not provided) Author contacted for outcome data: no |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "... participants were...randomly assigned..." (p.354) Method of randomisation not specified, however |
| Allocation concealment (selection bias) | Unclear risk | No information specified |
| Blinding (performance bias and detection bias) Subjects | High risk | The nature of the trial suggests it is unlikely participants could have remained blind to the fact they were allocated to a no treatment control group. However, without access to the participant information sheets and PLS, level of blinding cannot be ascertained. |
| Blinding (performance bias and detection bias) Assessors | Unclear risk | All outcomes self‐reported. Assessor blinding therefore not applicable. |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of participants with incomplete post‐intervention self‐reported depression scores: 12.5% (unbalanced) Means and SDs used in meta‐analysis based on what data: observed cases Intention‐to‐treat analyses: expectation‐maximisation imputation algorithm |
| Selective reporting (reporting bias) | Unclear risk | Protocol not available |
| Other bias | High risk | Trial conducted by those who developed the intervention |
| Implementation integrity | Unclear risk | Implementation integrity assessed: unclear if assessed Implementation integrity adequate: N/A Implementation integrity reported: N/A |