Kanwal 2018.
Methods | Design: RCT, parallel group Country: USA Setting: 4 Veteran Affairs clinics |
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Participants | Inclusion criteria: people with HCV infection (positive HCV ribonucleic acid test) who were seen in HCV clinics and who screened positive for major depression on the PHQ‐9 depression screening instrument (score > 10). Exclusion criteria: participants already receiving HCV treatment, no access to telephone, PHQ‐9 score < 10, currently in bereavement, current suicidal ideation, significant cognitive impairment (score > 10 on the Blessed Orientation Memory and Concentration Test), in care of court‐appointed guardian, diagnosis of schizophrenia, and bipolar disorder with admission for psychiatric diagnosis in the previous 12 months. Mean age (years): intervention group: 59 (SD 6); control group: 59 (SD 5) years) at 6 months; intervention group: 59 (SD 5.6); control group: 59.4 (SD 4.9) years at 12 months. Sex: 11 women; 252 men at 6 months; 9 women; 233 men at 12 months. Severity of depression: participants had a mean score 2 (SD 1) on the Hopkins Symptom Checklist at baseline. AD use status: 137 participants had received 'any depression treatment' in the past 6 months before study commencement; 133 were on a current AD prescription at the start of the trial. Comorbidities: hepatitis C |
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Interventions | Sample size (total): 309 enrolled; 292 completed baseline assessment interviews; only data for 263 presented by study authors. Length of trial: 12 months (6 and 12 months' follow‐up data presented). Intervention: collaborative care – remotely delivered intervention. Depression care team consisted of a nurse depression care manager, pharmacist, and psychiatrist – located off site and convened once a week and as needed by telephone or in person. Model adopted a 5‐step care model for depression focusing with the following components: self‐management education, depression care team treatment suggestions (counselling or pharmacotherapy, with consideration of participant preference), pharmacotherapy suggestions after review of depression treatment history by the clinical pharmacist, combination pharmacotherapy and speciality mental health counselling, and referral to speciality mental health. Depression care manager conducted telephone‐based monitoring every 2 weeks during acute treatment and every 4 weeks during continuation treatment, n = 156 (n = 129 reported). Control: usual care – participants received "standard of care" depression treatment, which typically included referral to speciality mental health clinics or depression treatment at integrated primary care – mental health clinics where patients had access to evidence‐based psychotherapy and pharmacotherapy available at each site. Usual care participants did not have interactions with the depression care manager or depression care team, n = 153 (n = 134 reported). |
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Outcomes | Depression symptom severity (Hopkins Symptom Checklist, SCL‐20, higher score = worse symptoms on a per‐protocol basis); depression response (defined as ≥ 50% decrease in the mean SCL‐20 score compared with baseline); depression remission (defined as a mean SCL‐20 score < 5 on a per‐protocol basis); depression‐free days; acceptability (defined as participants not attending follow‐up); death. Outcomes not used: depression‐free days; hepatitis C outcomes (not included in our protocol). |
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Notes | Sponsorship source: supported by grant SDP 10‐044 from the Veterans Health Administration, Health Services Research and Development Service. Trial registration identifier: NCT01143896 Date of recruitment: 2012–2014 Declarations of interest from primary researchers: the authors reported no financial relationships with commercial interests. Correspondence: none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "participants were randomly assigned to the intervention or to usual care in a 1:1 ratio according to a computer generated random assignment sequence stratified by clinic and generated in advance" (p. 1077). |
Allocation concealment (selection bias) | Unclear risk | No details. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Clinicians were not blinded to the depression care received by the patient" (p. 2550). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Baseline and six‐month data were collected by a telephone interviewer who was blinded to treatment assignment" (p. 1078). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Authors used ITT analysis on participants. Quote: "A total of 309 eligible patients were enrolled in the study. Of these, 292 patients completed baseline assessment interviews. Follow‐up data‐collection interviews were completed for 263 participants (90%) at six months" (p. 1076). Comment: data for 263 participants presented by study authors at 6 months in 1 published report, with data for 242 participants presented by study authors at 12 months in another published report. ClinicalTrials.gov (NCT01143896) details numbers lost to follow‐up and reasons. |
Selective reporting (reporting bias) | Low risk | Outcomes seem to have reported consistently between NCT‐provided data and published articles. |
Other bias | Low risk | None detected. |