Ciechanowski 2010.
Methods | Study design: Randomised controlled trial | |
Participants | Setting: Specialist setting Diagnosis: Clinically significant depression based on a score ≥ 10 on the PHQ‐9 Inclusion criteria: English reading and speaking, 18 years or older, had an ICD‐9 epilepsy diagnosis, and had attended the UW Regional Epilepsy Centre or neurology clinics within 2 years of recruitment. Exclusion criteria: Pregnancy or nursing, bipolar or psychotic disorder, current psychiatric treatment, substance abuse based on the CAGE questionnaire, cognitive impairment Age: Mean 43.9 (SD 11) years Gender: 53% female Ethnicity: 8% ethnic minority Country: United States Sample size (randomised): Total participants 80, intervention 40, control 40 |
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Interventions | Intervention: Programme to Encourage Active, Rewarding Lives for Seniors (PEARLS) Contains the four elements of collaborative care: 1) a multi‐professional approach to patient care: Neurologist (PCPs), social workers (CM), study psychiatrist (MH specialist) 2) a structured management plan: PST sessions were modified to provide greater emphasis on social and physical activation. The goal of physical activation was to assist patients in developing a regular physical activity programme consistent with national recommendations for mild to moderate activity of 30 minutes 5 days per week that would provide benefits but not increase risk for inducing seizures. Physical activation began during the third or fourth PST session, allowing patients to develop familiarity with problem‐solving skills. The goal of social activation was to increase patients’ interactions outside the home by using a resource list under the guidance of the CM. Each session included selecting and engaging in pleasant activities, using a suggestion list if necessary. 3) scheduled patient follow‐ups: Eight 50‐minute in‐home sessions over 19 weeks, in weeks 1, 2, 3, 5, 7, 11, 15, and 19. After 19 weeks, monthly brief telephone contact to assess clinical progress and use of PST 4) enhanced inter‐professional communication: CM and MH specialist met weekly or biweekly to review patients. MH specialist contacted PCP for patients lacking progress to recommend initiating or adjusting ADs and to assess potential medical and substance abuse aetiologies for depression. The MH specialist occasionally clarified details by contacting PCPs. Control: Treatment as usual enhanced by letters sent to PCPs and social workers reporting depression diagnosis with recommendations to continue treatment as usual |
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Outcomes | Depression (HSCL‐20): 6, 12, 18 months Medication use: 12 months Quality of Life (mental and physical health): 6, 12, 18 months |
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Notes | CM: case manager; DSM‐IV: Diagnostic and Statistical Manual fourth edition; HSCL: Hopkins Sympton Checklist; MH: mental health; PCP: primary care provider; PHQ‐9: Patient Health Questionnaire‐9; SD: standard deviation | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated in blocks using 50:50 allocation ratio |
Allocation concealment (selection bias) | Low risk | An individual not involved in the intervention generated randomisation sequence, enrolled and allocated patients |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Short‐term loss to follow‐up based on primary depression outcome (HSCL20) was: overall 15/80 (19%), 8/40 (20%) intervention and 7/40 (18%) control. Reasons for loss to follow‐up provided, with similar reasons across groups. 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 | Low risk | Assessor was not aware of treatment allocation |