Fann 2015.

Methods	Randomised controlled trial.
Participants	One hundred adults with TBI and a current diagnosis of major depressive disorder (MDD). Recruitment was conducted at community and clinical settings serving people with TBI, and through referrals from clinicians. Inclusion criteria: English‐speaking people over 18 years old, who had a documented history of mild to severe TBI, including criteria relating to Glasgow Coma Score (GCS), imaging abnormalities or duration of post‐traumatic amnesia (PTA. All participants had to meet diagnostic criteria for MDD with the use of the Structured Clinical Interview for Depression (SCID) and demonstrate symptoms of depression over the clinical cutoff on the Patient Health Questionnaire (PHQ‐9). Exclusion criteria: No stable home or access to telephone; history of diagnosis of schizophrenia; evidence of bipolar disorder, psychosis or suicidal intent, or current alcohol or drug dependence; currently receiving or planning to start evidence‐based psychotherapy for depression during the study; commencing or adjusting anti‐depressant medication during the study; or severe cognitive impairment as defined by scores below cutoff on specific neuropsychological tests.
Interventions	The intervention comprised a manualised CBT program written to be delivered by telephone. It was modified for TBI participants with an expansion in duration from eight weekly sessions to 12 and the addition of care management procedures for the life changes experienced by this population. Motivational interviewing was used to engage participants in treatment. The session material was presented in smaller portions, more slowly, and with greater repetition. Participants were provided with a workbook with in‐session materials and between‐session assignments. Two authors provided treatment and 10% of sessions were subject to fidelity checks.
Outcomes	Primary outcome measures: Hamilton Depression Rating Scale (HAMD‐17) Symptom Checklist‐20 (SCL‐20) Secondary outcome measures: MDD criteria based on the SCID Patient Global Impression (PGI) Satisfaction with Depression Care Working Alliance Inventory‐Short Form Sheehan Disability Scale MOS Short Form Health Questionnaire (SF‐36) Head Injury Symptom Checklist
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	All participants were randomised to an intervention. In order to increase participation in the study, the authors used a choice‐stratified approach in which participants had the option of choosing to be randomised to any intervention (CBT‐T vs CBT‐IP vs usual care), or one CBT intervention (CBT‐T or CBT‐IP) vs usual care. The random sequence was computer‐generated.
Allocation concealment (selection bias)	Low risk	Group allocation was centrally assigned following enrolment in the study.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Because of the nature of the interventions, it was not possible to blind participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Assessment was conducted over the telephone by trained study staff who were blind to randomisation status. However, most of the outcome measures rely on participant self‐report and therefore are subject to bias due to awareness of allocation. Even the HAMD, which is a clinician‐report scale, does rely upon patient self‐report for many items, and therefore cannot be considered to be an objective measure.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Eighty‐six percent of participants provided data at follow‐up.
Selective reporting (reporting bias)	Low risk	The outcome measures reported in the results section are consistent with those in the methods section. The trial protocol was registered in clinicaltrials.gov (identifier: NCT00878150). All primary outcomes and most secondary outcomes are reported in the final publication, albeit with some substitution of secondary measures prior to commencing data collection.
Other bias	Unclear risk	‐