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. 2015 Dec 14;2015(12):CD009871. doi: 10.1002/14651858.CD009871.pub2

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.
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)
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