Background Collaborative care (CC) could improve outcomes in primary care patients with common mental conditions. We assessed the effectiveness of a transdiagnostic model of telephone-based CC (tCC) delivered by lay providers to primary care patients with depression, anxiety, or at-risk drinking. Methods PARTNERS was a pragmatic trial in 502 primary care adults presenting with depressive symptoms, anxiety symptoms, or at-risk drinking randomized to (1) usual care by primary care providers (PCPs) enhanced with the results of computer-assisted telephone-based assessments (at baseline and 4, 8, and 12 months later) (enhanced usual care [eUC]) or (2) tCC consisting of eUC plus frequent telephone coaching and psychoeducation provided by mental health technicians who also communicated to the PCP recommendations from a psychiatrist for evidence-based pharmacotherapy, psychotherapy, or, when indicated, referrals to mental health services. The primary analysis compared the change on the 9-item Patient Health Questionnaire (PHQ-9) in participants presenting with depression ( n = 366) randomized to tCC versus eUC. Secondary analyses compared changes on the Generalized Anxiety Disorder-7 scale (GAD-7) in those presenting with anxiety ( n = 298); or change in the number of weekly drinks in those presenting with at-risk drinking ( n = 176). Results There were no treatment or time×treatment effects between tCC and eUC on PHQ-9 scores for patients with depression during the 12-month follow-up. However, there was a treatment effect (tCC > eUC) on GAD-7 scores in those with anxiety and a time×treatment interaction effect on the number of weekly drinks (tCC > eUC) in those with at-risk drinking. Conclusion Implementing transdiagnostic tCC for common mental disorders using lay providers appears feasible in Canadian primary care. While tCC was not better than eUC for depression, there were some benefits for those with anxiety or at-risk drinking. Future studies will need to confirm whether tCC differentially benefits patients with depression, anxiety, or at-risk drinking.
TPS7072 Background: Acute leukemia (AL) is characterized by rapid symptom onset requiring urgent hospitalization and initiation of intensive treatment with high mortality. Despite this, there is scant research on its psychological and physical impacts and even less on interventions to alleviate them [Bryant 2016]. We conducted a longitudinal study showing substantial physical and psychological distress in these patients [Rodin 2013; Zimmermann 2013; Nissim 2013; Nissim 2014; Gheihman 2016; Rodin 2018a; Shaulov 2019]. Despite this distress, we observed a lack of referrals for specialized psychosocial and palliative care. Based on these findings, we developed an integrated psychosocial and early palliative care (symptom control) intervention, Emotion And Symptom-focused Engagement (EASE), for AL [Rodin 2015]. In a subsequent randomized phase II trial of EASE in patients newly diagnosed with AL, we demonstrated its feasibility and found preliminary evidence that it reduces physical and psychological distress compared to usual care [Rodin 2020]. EASE includes: i) an 8-week manualized psychotherapy intervention tailored to AL to prevent and treat psychological symptoms through: supportive counselling and trauma-focused cognitive-behavioural therapy; and emotional assessment and affect modulation; ii) 4-week systematic screening of physical symptoms with automatic referrals to palliative care for the management of moderate to severe symptoms. Methods: We are conducting a multi-centre randomized controlled phase III trial of 266 AL patients comparing EASE to usual care in collaboration with the Canadian Cancer Trials Group at Princess Margaret Cancer Centre, Sunnybrook Health Sciences, Kingston Health Sciences and the Ottawa Hospital in Ontario, Canada. Patients are newly diagnosed with acute myeloid leukemia or acute lymphoblastic leukemia and randomized within two weeks of hospital admission for induction chemotherapy with curative intent. Patients randomized to EASE will receive psychological support from a trained mental health clinician for 8 weeks and will be assessed for physical symptoms twice weekly until discharged from hospital. Moderate to severe physical symptoms will trigger a referral to a symptom-control team for symptom management. The symptom-control team consists of a physician and nurse with expertise in symptom control and other professionals as needed. All participants will be assessed for physical symptom severity, psychological distress, quality of life and satisfaction with care at baseline, 4, 8, 12 weeks, 6 and 12 months. Hypotheses will be tested using multilevel modeling (MLM) with maximum likelihood estimation, conducted as intention-to-treat analyses. The DMC last reviewed the trial in April 2021 and suggested that the trial continue as planned. Clinical trial information: NCT04224974.
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