Piette 2011.

Methods	Study design: Randomised controlled trial
Participants	Setting: Primary care Diagnosis: Depression assessed by PHQ‐9 score of greater than 11 and BDI score of over 14 Inclusion criteria: At least 21 years old, diagnosis of type 2 diabetes and using antihyperglycaemic medication Exclusion criteria: Bipolar disorder or schizophrenia, or in active treatment for another serious illness such as severe heart failure, severe chronic obstructive pulmonary disease, or end‐stage renal disease.  Patients using antidepressant medication at the time of the screening were excluded if they reported a change in the prior 30 days in either their antidepressant medication or the physician prescribing their antidepressants, unable to walk either 1 block or 10 minutes without rest, scored < 21 on the Short Orientation Memory Concentration Test, or they reported drug or alcohol problems during the prior 3 months as measured by a modified version of the CAGE questionnaire Age: Mean 56 (SD 10.1) years Gender: 52% female Ethnicity: 84% White Country: United States Sample size (randomised): Total participants 339, intervention 172, control 167
Interventions	Intervention: Telephone CBT Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care provider (PCP), MH/primary care nurses (CM), CBT therapist (MH specialist) 2) a structured management plan: Telephone CBT focused on patients’ depressive symptoms, introduced a walking programme, and emphasised the links between depression, physical activity, and diabetes outcomes. CMs and patients used a manual to guide sessions and monitored each week’s CBT goals. CMs monitored patients’ depressive symptoms and their activity levels. Patient manuals were used to record homework exercises and monitor progress. PCPs were informed of any: suicidal ideation, discontinuation of ADs, persistent elevated depressive symptoms, need for a prescription refill. Additional contacts to discuss patients other health problems were at the CMs discretion 3) scheduled patient follow‐ups: Acute = 12 weekly telephone CBT sessions, maintenance = 9 monthly booster sessions 4) enhanced inter‐professional communication: PCPs received written diagnosis detail after assessment and every 3 months thereafter. PCPs were alerted by fax and telephone in the event of any: suicidal ideation, discontinuation of ADs, persistent elevated depressive symptoms, or need for a prescription refill. CMs received weekly group supervision from the MH specialist. Control: Treatment as usual enhanced as patients received a self‐help book on CBT for depression, educational materials about depression and walking and diabetes, and a list of local resources for depression. With permission PCPs were notified about their depression scores
Outcomes	Depression (BDI): 12 months Medication use: 12 months Quality of Life (mental and physical health): 12 months
Notes	AD: antidepressant; BDI: Beck Depression Inventory; CM: case manager; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random numbers table
Allocation concealment (selection bias)	Low risk	Sealed envelopes
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Short‐term loss to follow‐up based on primary depression outcome (BDI mean) was: overall 48/339 (14%), 27/172 (16%) intervention and 21/167 (13%) control. Reasons for loss to follow‐up not provided. Used intention‐to‐treat analysis
Selective reporting (reporting bias)	Unclear risk	Insufficient information available to assess
Other bias	Unclear risk	Insufficient information available to assess
Implementation Integrity	Low risk	Attempts were made to assess implementation integrity (e.g. direct observation or rating of tapes)
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel could not be blinded, outcome likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information available to assess