Mental Health Assessment and Prescribing by Alberta Pharmacists

NCT ID: NCT04410575

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2025-05-31

Brief Summary

This is a clinical trial evaluating the experimental intervention of enhanced pharmacist care by pharmacists with additional prescribing authorization (APA) in Alberta, for patients newly diagnosed with Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).

Detailed Description

Primary objective

-To evaluate the effect of enhanced pharmacist care possible by community pharmacists with APA in comparison with usual care (standard pharmacist care and physician care) for patients with MDD and/or GAD initiated on pharmacotherapy, with focus on interventions that include:

i) monitoring (lab ordering and interpretation, clinical monitoring of MDD and GAD) ii) patient education iii) referral facilitation (in collaboration with prescribing physician) iv) prescribing (dose adjustment and the addition of adjunctive medication)

Secondary objectives

• To evaluate the effect of APA pharmacist interventions on:

i)Clinical:

• The rate of achieving clinical response and remission of MDD and/or GAD compared to usual care (using PHQ-9/GAD-7)
• Change in the mean PHQ-9 and GAD-7 score
• Cognitive and functional impairment related to MDD and/or GAD
• The occurrence of relapse of depression and/or anxiety
• The proportion of patients receiving appropriate and optimized depression and anxiety medication
• Patient complaints and/or experiences of medication-related side effects during treatment for MDD and/or GAD (i.e. GI intolerance, dizziness, weight gain)

ii) Process:

• The impact of the interventions on patient satisfaction and quality of life impact (Patient survey)
• Assure sustainability by exploring enabling (i.e. pharmacist reimbursement framework) and potential barrier forces (i.e. pharmacist training in managing patients with MDD and GAD)

Conditions

Major Depressive Disorder; Generalized Anxiety Disorder; Pharmacist-Patient Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Participants enrolled in the intervention group will receive pharmacist interventions, in addition to standard care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians), at enrollment (month 0) and at 1, 3, and 6 month in-person follow-up appointments

Group Type: EXPERIMENTAL

Standard Pharmacist Care

Intervention Type: OTHER

Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)

Reviewed Questionnaire tool results with participant

Intervention Type: OTHER

Pharmacist reviews results of the patient-administered PHQ-9 and/or GAD-7 questionnaire tool, at the scheduled follow-up appointment

Patient Clinical Assessment

Intervention Type: OTHER

Pharmacist conducts clinical assessment of the participant's major depressive disorder and/or generalized anxiety, which can include: appearance, current mood, sleeping patterns, mental health, medical history, social history, family history, relationship with others, suicidal ideation, previous suicide attempts or hospitalizations, current employment status

Psychotherapy Referral

Intervention Type: OTHER

Pharmacist initiates collaboration with physician to arrange referral for psychotherapy, including: psychologist, social worker, counsellor, psychiatrist

Pharmacist initiated interim telephone follow-up with participant

Intervention Type: OTHER

Interim telephone follow-up conducted by the pharmacist since the last in-person follow-up \& a minimum of 1-2 weeks after the last in-person follow-up that involved a dose adjustment, prescribing of adjunctive medication, or discontinuation of therapy (Note: a telephone follow-up does not replace the scheduled in-person follow-up)

Communication update with physician after participant contact

Intervention Type: OTHER

Pharmacist provides communication update (fax or electronic charting) with the participant's physician after contact with the participant

Medication Counselling and Educational Support

Intervention Type: OTHER

Pharmacist provides medication related counselling and educational support to participant

Non-medication Counselling

Intervention Type: OTHER

Pharmacist provides non-medication related counselling and educational support to participant

Identification of drug interaction

Intervention Type: OTHER

Pharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety

Identification of drug adverse effect

Intervention Type: OTHER

Pharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety

Identification of severe deterioration

Intervention Type: OTHER

Pharmacist identification of participant severe deterioration (i.e. suicide attempt)

Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing

Intervention Type: OTHER

Pharmacist collaborates, discusses, and makes recommendations to physician re: treatment plan for MDD and/or GAD (as per CANMAT guidelines), which can include: medication dose adjustment, change to alternative medication, add-on, or deprescribing

Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing

Intervention Type: OTHER

Pharmacist initiated alteration to treatment plan for MDD and/or GAD (as per CANMAT guidelines), which can include: medication dose adjustment, change to alternative medication, add-on, or deprescribing

Control Group (Standard Pharmacist Care)

Patients randomized to the usual care group will receive standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians) and physician care, at enrollment (month 0) with no specific interventions for the duration of 6 months, until the 6 month in-person follow-up appointment

Group Type: ACTIVE_COMPARATOR

Standard Pharmacist Care

Intervention Type: OTHER

Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)

Medication Counselling and Educational Support

Intervention Type: OTHER

Pharmacist provides medication related counselling and educational support to participant

Non-medication Counselling

Intervention Type: OTHER

Pharmacist provides non-medication related counselling and educational support to participant

Identification of drug interaction

Intervention Type: OTHER

Pharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety

Identification of drug adverse effect

Intervention Type: OTHER

Pharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety

Identification of severe deterioration

Intervention Type: OTHER

Pharmacist identification of participant severe deterioration (i.e. suicide attempt)

Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing

Intervention Type: OTHER

Pharmacist collaborates, discusses, and makes recommendations to physician re: treatment plan for MDD and/or GAD (as per CANMAT guidelines), which can include: medication dose adjustment, change to alternative medication, add-on, or deprescribing

Interventions

Standard Pharmacist Care

Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)

Intervention Type: OTHER

Reviewed Questionnaire tool results with participant

Pharmacist reviews results of the patient-administered PHQ-9 and/or GAD-7 questionnaire tool, at the scheduled follow-up appointment

Intervention Type: OTHER

Patient Clinical Assessment

Pharmacist conducts clinical assessment of the participant's major depressive disorder and/or generalized anxiety, which can include: appearance, current mood, sleeping patterns, mental health, medical history, social history, family history, relationship with others, suicidal ideation, previous suicide attempts or hospitalizations, current employment status

Intervention Type: OTHER

Psychotherapy Referral

Pharmacist initiates collaboration with physician to arrange referral for psychotherapy, including: psychologist, social worker, counsellor, psychiatrist

Intervention Type: OTHER

Pharmacist initiated interim telephone follow-up with participant

Interim telephone follow-up conducted by the pharmacist since the last in-person follow-up \& a minimum of 1-2 weeks after the last in-person follow-up that involved a dose adjustment, prescribing of adjunctive medication, or discontinuation of therapy (Note: a telephone follow-up does not replace the scheduled in-person follow-up)

Intervention Type: OTHER

Communication update with physician after participant contact

Pharmacist provides communication update (fax or electronic charting) with the participant's physician after contact with the participant

Intervention Type: OTHER

Medication Counselling and Educational Support

Pharmacist provides medication related counselling and educational support to participant

Intervention Type: OTHER

Non-medication Counselling

Pharmacist provides non-medication related counselling and educational support to participant

Intervention Type: OTHER

Identification of drug interaction

Pharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety

Intervention Type: OTHER

Identification of drug adverse effect

Pharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety

Intervention Type: OTHER

Identification of severe deterioration

Pharmacist identification of participant severe deterioration (i.e. suicide attempt)

Intervention Type: OTHER

Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing

Pharmacist collaborates, discusses, and makes recommendations to physician re: treatment plan for MDD and/or GAD (as per CANMAT guidelines), which can include: medication dose adjustment, change to alternative medication, add-on, or deprescribing

Intervention Type: OTHER

Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing

Pharmacist initiated alteration to treatment plan for MDD and/or GAD (as per CANMAT guidelines), which can include: medication dose adjustment, change to alternative medication, add-on, or deprescribing

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults (≥ 18 years of age) newly diagnosed with MDD and/or GAD, including:
• Patients starting on medications for the management of adults with MDD
• Patients starting on medications for the management of GAD

Exclusion Criteria

• Pregnancy
• Non-Alberta residents
• Unwilling or unable to participate in regular follow-up visits
• Unwilling to participate/sign consent form
• ≥2 suicide attempts per year
• Severe, psychotic, and catatonic depression
• History of and/or current substance abuse, intoxication, addiction or withdrawal
• Patients diagnosed with comorbid anxiety disorders other than GAD, including: panic -disorder, agoraphobia, specific phobia, social anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder
• Patients diagnosed with comorbid depressive disorder other than MDD, including: depressive disorder due to another medical condition (e.g. hypothyroidism, MS, OSA, -Parkinsons, stroke, TBI, Vitamin B12 insufficiency, Huntington disease, adrenal insufficiency, mononucleosis, systemic lupus erythematosus), adjustment disorder with depressed mood
• Patients diagnosed with concurrent ADHD, bipolar disorder, schizophrenia and schizoaffective disorder

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yazid Al Hamarneh, BSc (Pharm), PhD, CDM

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

REB ID Pro00093776

Identifier Type: -

Identifier Source: org_study_id