Dwight‐Johnson 2011.
Methods | Study design: Pilot randomised controlled trial | |
Participants | Setting: Primary care Diagnosis: Probable major depressive disorder assessed using the PHQ‐9. Criteria were the reporting of a minimum of five of the nine symptoms assessed and a cut‐off score of 10 Inclusion criteria: Rural areas, self‐identified as Latino, spoke English or Spanish Exclusion criteria: Bipolar disorder, cognitive impairment, current or lifetime psychotic symptoms or disorder, current substance abuse, acute suicidal ideation Age: Mean 39.8 (SD 10.56) years Gender: 78% female Ethnicity: 91% Mexican Country: United States Sample size (randomised): Total participants 101, intervention 50, control 51 |
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Interventions | Treatment: Telephone CBT Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Primary care provider (PCP), social workers (CM), social workers, psychiatrist, and psychologist/psychiatrist (MH specialist) 2) a structured management plan: Initial structured assessment of clinical history, motivation for treatment, and use of strategies to enhance patients’ motivation to engage in treatment (this session could be face‐to‐face). Each session focused on a chapter from a patient workbook that had been translated into the Spanish language and made culturally relevant. The sessions emphasised behavioural activation and strategies for identifying, interrupting, and distancing oneself from negative thoughts. Each session included structured assessment of depressive symptoms, review of the previous session, debriefing of homework assignment, introduction of new material, description of the new homework assignment, and a motivational assessment and enhancement exercise focused on the homework assignment. If indicated, CMs made brief supportive telephone contacts between sessions and could refer the patient for case management services for depression care needs, such as assistance in making appointments with clinic providers and referrals to community services. The CM did not take an active role in management of ADs but could discuss medication as a treatment option and ask about medication adherence all questions related to medication were referred back to PCP. 3) scheduled patient follow‐ups: CBT = 8 telephone sessions. 4) enhanced inter‐professional communication: CMs liaised with PCPs when required in relation to medication. Suicide safety plans when necessary were communicated to PCP. CMs had weekly supervision with a team of MH specialists. Control: Treatment as usual enhanced as patients were encouraged to talk with their PCP about depression treatment and PCPs received a letter informing them of their patient’s depression status and study enrolment. |
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Outcomes | Depression (HSCL and PHQ‐9): 6 weeks, 3, 6 months Satisfaction: 6 weeks, 3, 6 months |
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Notes | AD: antidepressant; CBT: cognitive behaviour therapy; CM: case manager; HSCL: Hopkins Sympton Checklist; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire–9 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Stratified permuted‐block randomisation |
Allocation concealment (selection bias) | Low risk | Allocation revealed by telephone |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Short‐term loss to follow‐up based on primary depression outcome (PHQ‐9) was: overall 24/101 (24%), 8/50 (16%) intervention and 16/51 (31%) control. Reasons for loss to follow‐up not provided. Intention‐to‐treat analysis reported based on the assumption data is missing at random |
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 | Low risk | Assessor was not aware of treatment allocation |