An interventional study of Psychoeducation in Depressive Disorder, sponsored by University of Alberta. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
This a comparative study of enhanced pharmacist care and regular care of patients starting on antidepressants. When providing participants with enhanced care pharmacists will use the Health Professional's Antidepressant Communications Tool (Health PACT) a minimum of three times during face-to-face discussions. This tool was developed specifically for this study. All participants will be followed for 26 weeks and will be assessed for duration of use of their antidepressant, adherence to treatment, and clinical response.
This proposal describes a combined observational study (Phase I) and randomized controlled trial (Phase II). The primary aim of the observational study is to determine the disorders, in particular the types of depression, for which family physicians prescribe antidepressants. The primary aim of the randomized controlled trial (RCT) is to compare the effect of a brief psycho-educational intervention by pharmacists with usual care on antidepressant persistence.
Subjects (n=621 phase 1, n=106 phase 2) will be patients presenting to a pharmacy in Edmonton with a prescription for an antidepressant from a family physician and meeting the following criteria: no antidepressants taken in the preceding six months; 18 years of age or older, and fluent in English. Subjects will be interviewed using modified versions of the depression, generalized anxiety disorder and panic disorder sections of the Diagnostic Interview Schedule; the Beck Depression Inventory; the Beck Anxiety Inventory; and a question on recent stressful life events. For Phase 1 the proportion of subjects with the following DSM-IV diagnoses will be estimated: major depression, "minor depression," generalized anxiety disorder, panic disorder; minor depression will be categorized into "adjustment disorder with depressed mood" and "adjustment disorder with mixed anxiety and depressed mood". The family doctor will be contacted and asked for the diagnosis that prompted the antidepressant prescription.
Subjects with DSM IV depression will be invited to participate in Phase 2. Individuals will be randomized to a pharmacist intervention with the Health PACT, or to usual care. Using the newly-developed Antidepressant Compliance Questionnaire, information on predictors of adherence will be collected at the baseline interview. At weeks 4, 8, 16 and 26, subjects will be contacted by phone and questioned on antidepressant adherence and persistence. At week 8 (or the exit interview if a subject leaves the study early), we will administer the Beck Depression Inventory and the Beck Anxiety Inventory. The primary outcome is treatment persistence, defined as the time to stop antidepressant use. Adherence, defined by the medication possession ratio (MPR), will be also be measured.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 106 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
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Exclusion Criteria:
Persistence
Adherence (mean possession ratio)
Beck Depression Inventory symptom improvement
Beck Anxiety Inventory symptom improvement
Change in antidepressant compliance questionnaire responses
This study is terminated, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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University of Alberta