Ashman 2014.
Methods | Randomised controlled trial. | |
Participants | Seventy‐seven people who had sustained a traumatic brain injury who were living in the community. Participants were recruited from an outpatient rehabilitation service, clinic newsletter and word of mouth. Inclusion criteria: Medically documented traumatic brain injury; current DSM‐IV diagnosis of a depressive disorder or Beck Depression Inventory (BDI‐II) score greater than 20; 18 to 55 years old. Exclusion criteria: Presence or history of psychosis, substance abuse, pre‐existing neurological disorder, mental retardation, or active suicidality; currently in psychotherapy; commenced or changed antidepressant medication within the past six months. |
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Interventions | All participants attended 16 sessions of individual treatment over three months. Participants were allocated either for cognitive‐behavioural therapy (CBT) or supportive psychotherapy (SPT). | |
Outcomes |
Primary outcome measure: Presence of a DSM‐IV depressive mood disorder assessed by the Structured Clinical Interview for DSM‐IV (SCID) Secondary outcome measures: Beck Depression Inventory ‐ second edition (BDI‐II) Anxiety disorder and substance abuse modules of the SCID State‐Trait Anxiety Inventory (STAI) Life‐3 Interpersonal Support Evaluation List (ISEL) Life Experiences Survey (LES) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence generation. |
Allocation concealment (selection bias) | Low risk | Random number sequence was concealed in pre‐sealed individual envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Due to disparate experimental conditions, blinding of participants and personnel was not possible. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Primary outcome measure was a clinical scale, applied by a clinician, who was blind to the treatment. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Of 77 participants randomised to a treatment, only 43 completed the study. Twenty‐two dropped out after baseline assessment and a further 12 participants did not complete the study. |
Selective reporting (reporting bias) | Low risk | The published study is consistent with an earlier conference abstract (Ashman 2012) and the protocol registered on Trialscentral.org. The study was registered on clinicaltrials.gov, study ID: NCT00211835. |
Other bias | Unclear risk | ‐ |