Mental Health Assessment and Prescribing by Alberta Pharmacists

NCT04410575 | Completed

• 1 other identifier: REB ID Pro00093776
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Pharmacist; Prescribing; Major Depressive Disorder; Generalized Anxiety Disorder; Mental Health; Intervention; Expanded Scope

Outcome Measures

Primary Outcomes (2)

• Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score

  Mean score difference in PHQ-9 score from baseline to end of study between intervention (pharmacist intervention + standard pharmacist care) group vs control (standard pharmacist care) group; PHQ-9 scores reflect depression severity, ranges from 0-27 (Scores: 0-4 none/minimal, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe)

  6 months

• Mean score difference in Generalized Anxiety Disorder 7-item (GAD-7) score

  Mean score difference in GAD-7 score from baseline to end of study between intervention (pharmacist intervention + standard pharmacist care) group vs control (standard pharmacist care) group; GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)

  6 months

Secondary Outcomes (5)

• Difference in proportion of participants achieving clinically significant treatment response in Patient Health Questionnaire 9-item (PHQ-9) score between pharmacist intervention vs. standard pharmacist care

  6 months

• Difference in proportion of participants achieving clinically significant treatment response in Generalized Anxiety Disorder 7-item (GAD-7) score between pharmacist intervention vs. standard pharmacist care

  6 months

• Difference in the proportion of participants with Major Depressive Disorder (MDD) to achieve Patient Health Questionnaire 9-item (PHQ-9) score <5

  6 months

• Difference in the proportion of participants with Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score <5

  6 months

• Percentage difference in self-reported safety concerns disclosed by participant to pharmacist partner, between intervention (pharmacist intervention + standard pharmacist care) and control (standard pharmacist care) study groups, during the study period.

  6 months

Study Arms (2)

Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

EXPERIMENTAL

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

Other: Standard Pharmacist Care; Other: Reviewed Questionnaire tool results with participant; Other: Patient Clinical Assessment; Other: Psychotherapy Referral; Other: Pharmacist initiated interim telephone follow-up with participant; Other: Communication update with physician after participant contact; Other: Medication Counselling and Educational Support; Other: Non-medication Counselling; Other: Identification of drug interaction; Other: Identification of drug adverse effect; Other: Identification of severe deterioration; Other: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing; Other: Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing

Control Group (Standard Pharmacist Care)

ACTIVE COMPARATOR

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

Other: Standard Pharmacist Care; Other: Medication Counselling and Educational Support; Other: Non-medication Counselling; Other: Identification of drug interaction; Other: Identification of drug adverse effect; Other: Identification of severe deterioration; Other: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing

Interventions

Standard Pharmacist Care OTHER

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

Control Group (Standard Pharmacist Care); Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Reviewed Questionnaire tool results with participant OTHER

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

Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Patient Clinical Assessment 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

Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Psychotherapy Referral OTHER

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

Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Pharmacist initiated interim telephone follow-up with participant 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)

Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Communication update with physician after participant contact OTHER

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

Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Medication Counselling and Educational Support OTHER

Pharmacist provides medication related counselling and educational support to participant

Control Group (Standard Pharmacist Care); Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Non-medication Counselling OTHER

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

Control Group (Standard Pharmacist Care); Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Identification of drug interaction OTHER

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

Control Group (Standard Pharmacist Care); Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Identification of drug adverse effect OTHER

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

Control Group (Standard Pharmacist Care); Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Identification of severe deterioration OTHER

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

Control Group (Standard Pharmacist Care); Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

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

Control Group (Standard Pharmacist Care); Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

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

Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Generalized Anxiety Disorder; Psychological Well-Being

Interventions

Deprescriptions

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Anxiety Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

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

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Stratified randomization of participants via blocking factor to either pharmacist intervention or standard pharmacist care groups. Participants will be assigned a unique identifier number \& group allocation for the duration of their participation in the study (also recorded by the pharmacy partner to ensure consistency in the delivery of pharmacist interventions described by the participant's group allocation. The participant is sent a secured electronic link (to the contact number or email they provided in the written consent form) of the electronic version of the PHQ-9/GAD-7 questionnaire tool to complete. The study data (from the participant's electronic questionnaire tool results) will be sent directly to a centralized \& secured website/spreadsheet to ensure allocation concealment for the investigational team. The participant will report their score to the pharmacist participant through an electronic recording platform
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center randomized control trial evaluating the mean difference in depression and anxiety score with patients with major depressive disorder (MDD) and/or generalized anxiety disorder (GAD) by pharmacists with prescribing \& management interventions in comparison to pharmacist management per standard pharmacist care.

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 1, 2020
• Study Start: March 22, 2023
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)