<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04410575</url>
  </required_header>
  <id_info>
    <org_study_id>REB ID Pro00093776</org_study_id>
    <nct_id>NCT04410575</nct_id>
  </id_info>
  <brief_title>Mental Health Assessment and Prescribing by Alberta Pharmacists</brief_title>
  <acronym>MAP-AP</acronym>
  <official_title>Mental Health Assessment and Prescribing by Alberta Pharmacists (MAP-AP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a clinical trial evaluating the experimental intervention of enhanced pharmacist care&#xD;
      by pharmacists with additional prescribing authorization (APA) in Alberta, for patients newly&#xD;
      diagnosed with Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective&#xD;
&#xD;
      -To evaluate the effect of enhanced pharmacist care possible by community pharmacists with&#xD;
      APA in comparison with usual care (standard pharmacist care and physician care) for patients&#xD;
      with MDD and/or GAD initiated on pharmacotherapy, with focus on interventions that include:&#xD;
&#xD;
      i) monitoring (lab ordering and interpretation, clinical monitoring of MDD and GAD) ii)&#xD;
      patient education iii) referral facilitation (in collaboration with prescribing physician)&#xD;
      iv) prescribing (dose adjustment and the addition of adjunctive medication)&#xD;
&#xD;
      Secondary objectives&#xD;
&#xD;
        -  To evaluate the effect of APA pharmacist interventions on:&#xD;
&#xD;
           i)Clinical:&#xD;
&#xD;
        -  The rate of achieving clinical response and remission of MDD and/or GAD compared to&#xD;
           usual care (using PHQ-9/GAD-7)&#xD;
&#xD;
        -  Change in the mean PHQ-9 and GAD-7 score&#xD;
&#xD;
        -  Cognitive and functional impairment related to MDD and/or GAD&#xD;
&#xD;
        -  The occurrence of relapse of depression and/or anxiety&#xD;
&#xD;
        -  The proportion of patients receiving appropriate and optimized depression and anxiety&#xD;
           medication&#xD;
&#xD;
        -  Patient complaints and/or experiences of medication-related side effects during&#xD;
           treatment for MDD and/or GAD (i.e. GI intolerance, dizziness, weight gain)&#xD;
&#xD;
      ii) Process:&#xD;
&#xD;
        -  The impact of the interventions on patient satisfaction and quality of life impact&#xD;
           (Patient survey)&#xD;
&#xD;
        -  Assure sustainability by exploring enabling (i.e. pharmacist reimbursement framework)&#xD;
           and potential barrier forces (i.e. pharmacist training in managing patients with MDD and&#xD;
           GAD)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 22, 2023</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 22, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>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 &amp; management interventions in comparison to pharmacist management per standard pharmacist care.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Stratified randomization of participants via blocking factor to either pharmacist intervention or standard pharmacist care groups.&#xD;
Participants will be assigned a unique identifier number &amp; 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.&#xD;
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.&#xD;
The study data (from the participant's electronic questionnaire tool results) will be sent directly to a centralized &amp; 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</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score</measure>
    <time_frame>6 months</time_frame>
    <description>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;&#xD;
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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean score difference in Generalized Anxiety Disorder 7-item (GAD-7) score</measure>
    <time_frame>6 months</time_frame>
    <description>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;&#xD;
GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>6 months</time_frame>
    <description>Clinically significant treatment response for the PHQ-9 is defined as a reduction in PHQ-9 score by at least 50% from baseline;&#xD;
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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>6 months</time_frame>
    <description>Clinically significant treatment response for the GAD-7 is defined as a reduction in GAD-7 score by at least 50% from baseline;&#xD;
GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the proportion of participants with Major Depressive Disorder (MDD) to achieve Patient Health Questionnaire 9-item (PHQ-9) score &lt;5</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in the proportion of participants with MDD to achieve PHQ-9 score &lt;5 (i.e. remission/no depression) between the pharmacist intervention and standard pharmacist care groups&#xD;
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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the proportion of participants with Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score &lt;5</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in the proportion of participants with GAD to achieve GAD-7 score &lt;5 (i.e. remission/no anxiety) between the pharmacist intervention and standard pharmacist care groups;&#xD;
GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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.</measure>
    <time_frame>6 months</time_frame>
    <description>The participant discloses to the pharmacist partner at any time during the duration of study, events that fit the description of a safety concern and measured via frequency of occurrence.&#xD;
Safety concerns include:&#xD;
1) Adverse Medication Effects 2) Suicide Ideation/attempt, 3) Causing withdrawal from Study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">94</enrollment>
  <condition>Major Depressive Disorder</condition>
  <condition>Generalized Anxiety Disorder</condition>
  <condition>Pharmacist-Patient Relations</condition>
  <arm_group>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (Standard Pharmacist Care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Pharmacist Care</intervention_name>
    <description>Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)</description>
    <arm_group_label>Control Group (Standard Pharmacist Care)</arm_group_label>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Reviewed Questionnaire tool results with participant</intervention_name>
    <description>Pharmacist reviews results of the patient-administered PHQ-9 and/or GAD-7 questionnaire tool, at the scheduled follow-up appointment</description>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Clinical Assessment</intervention_name>
    <description>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</description>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychotherapy Referral</intervention_name>
    <description>Pharmacist initiates collaboration with physician to arrange referral for psychotherapy, including: psychologist, social worker, counsellor, psychiatrist</description>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacist initiated interim telephone follow-up with participant</intervention_name>
    <description>Interim telephone follow-up conducted by the pharmacist since the last in-person follow-up &amp; 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)</description>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Communication update with physician after participant contact</intervention_name>
    <description>Pharmacist provides communication update (fax or electronic charting) with the participant's physician after contact with the participant</description>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medication Counselling and Educational Support</intervention_name>
    <description>Pharmacist provides medication related counselling and educational support to participant</description>
    <arm_group_label>Control Group (Standard Pharmacist Care)</arm_group_label>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-medication Counselling</intervention_name>
    <description>Pharmacist provides non-medication related counselling and educational support to participant</description>
    <arm_group_label>Control Group (Standard Pharmacist Care)</arm_group_label>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Identification of drug interaction</intervention_name>
    <description>Pharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety</description>
    <arm_group_label>Control Group (Standard Pharmacist Care)</arm_group_label>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Identification of drug adverse effect</intervention_name>
    <description>Pharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety</description>
    <arm_group_label>Control Group (Standard Pharmacist Care)</arm_group_label>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Identification of severe deterioration</intervention_name>
    <description>Pharmacist identification of participant severe deterioration (i.e. suicide attempt)</description>
    <arm_group_label>Control Group (Standard Pharmacist Care)</arm_group_label>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing</intervention_name>
    <description>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</description>
    <arm_group_label>Control Group (Standard Pharmacist Care)</arm_group_label>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing</intervention_name>
    <description>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</description>
    <arm_group_label>Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Adults (≥ 18 years of age) newly diagnosed with MDD and/or GAD, including:&#xD;
&#xD;
          -  Patients starting on medications for the management of adults with MDD&#xD;
&#xD;
          -  Patients starting on medications for the management of GAD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Non-Alberta residents&#xD;
&#xD;
          -  Unwilling or unable to participate in regular follow-up visits&#xD;
&#xD;
          -  Unwilling to participate/sign consent form&#xD;
&#xD;
          -  ≥2 suicide attempts per year&#xD;
&#xD;
          -  Severe, psychotic, and catatonic depression&#xD;
&#xD;
          -  History of and/or current substance abuse, intoxication, addiction or withdrawal&#xD;
&#xD;
          -  Patients diagnosed with comorbid anxiety disorders other than GAD, including: panic&#xD;
             -disorder, agoraphobia, specific phobia, social anxiety disorder, obsessive-compulsive&#xD;
             disorder, posttraumatic stress disorder&#xD;
&#xD;
          -  Patients diagnosed with comorbid depressive disorder other than MDD, including:&#xD;
             depressive disorder due to another medical condition (e.g. hypothyroidism, MS, OSA,&#xD;
             -Parkinsons, stroke, TBI, Vitamin B12 insufficiency, Huntington disease, adrenal&#xD;
             insufficiency, mononucleosis, systemic lupus erythematosus), adjustment disorder with&#xD;
             depressed mood&#xD;
&#xD;
          -  Patients diagnosed with concurrent ADHD, bipolar disorder, schizophrenia and&#xD;
             schizoaffective disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yazid Al Hamarneh, BSc (Pharm), PhD, CDM</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yazid Al Hamarneh, BSc (Pharm), PhD, CDM</last_name>
    <phone>(780) 492-9608</phone>
    <email>yazid.alhamarneh@ualberta.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Matthew Chow, BSc Pharm, PharmD</last_name>
    <phone>(587) 999-0778</phone>
    <email>mchow1@ualberta.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alberta</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2R3</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yazid Al Hamarneh, BSc (Pharm), PhD, CDM</last_name>
      <phone>(780) 492-9608</phone>
      <email>Yazid.Alhamarneh@ualberta.ca</email>
    </contact>
    <contact_backup>
      <last_name>Matthew Chow, BScPharm, PharmD</last_name>
      <phone>(587)999-0778</phone>
      <email>mchow1@ualberta.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>April 10, 2023</last_update_submitted>
  <last_update_submitted_qc>April 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacist</keyword>
  <keyword>Prescribing</keyword>
  <keyword>Major Depressive Disorder</keyword>
  <keyword>Generalized Anxiety Disorder</keyword>
  <keyword>Mental Health</keyword>
  <keyword>Intervention</keyword>
  <keyword>Expanded Scope</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04410575
org study id: REB ID Pro00093776
nct id: NCT04410575
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 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.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: 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
measure: Mean score difference in Patient Health Questionnaire 9-item (PHQ-9) score
time frame: 6 months
description: 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)
measure: Mean score difference in Generalized Anxiety Disorder 7-item (GAD-7) score
time frame: 6 months
description: 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)
measure: 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
time frame: 6 months
description: Clinically significant treatment response for the PHQ-9 is defined as a reduction in PHQ-9 score by at least 50% from baseline;
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)
measure: 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
time frame: 6 months
description: Clinically significant treatment response for the GAD-7 is defined as a reduction in GAD-7 score by at least 50% from baseline;
GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)
measure: Difference in the proportion of participants with Major Depressive Disorder (MDD) to achieve Patient Health Questionnaire 9-item (PHQ-9) score <5
time frame: 6 months
description: Difference in the proportion of participants with MDD to achieve PHQ-9 score <5 (i.e. remission/no depression) between the pharmacist intervention and standard pharmacist care groups
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)
measure: Difference in the proportion of participants with Generalized Anxiety Disorder (GAD) to achieve Generalized Anxiety Disorder 7-item (GAD-7) score <5
time frame: 6 months
description: Difference in the proportion of participants with GAD to achieve GAD-7 score <5 (i.e. remission/no anxiety) between the pharmacist intervention and standard pharmacist care groups;
GAD-7 scores reflect anxiety severity; Ranges from 0-21 (Scores: 0-4 none/minimal. 5-9 mild, 10-14 moderate, 15-21 severe)
measure: 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.
time frame: 6 months
description: The participant discloses to the pharmacist partner at any time during the duration of study, events that fit the description of a safety concern and measured via frequency of occurrence.
Safety concerns include:
1) Adverse Medication Effects 2) Suicide Ideation/attempt, 3) Causing withdrawal from Study
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
arm group type: Experimental
description: 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
arm group label: Control Group (Standard Pharmacist Care)
arm group type: Active Comparator
description: 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
intervention type: Other
intervention name: Standard Pharmacist Care
description: Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)
arm group label: Control Group (Standard Pharmacist Care)
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Reviewed Questionnaire tool results with participant
description: Pharmacist reviews results of the patient-administered PHQ-9 and/or GAD-7 questionnaire tool, at the scheduled follow-up appointment
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Patient Clinical Assessment
description: 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
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Psychotherapy Referral
description: Pharmacist initiates collaboration with physician to arrange referral for psychotherapy, including: psychologist, social worker, counsellor, psychiatrist
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Pharmacist initiated interim telephone follow-up with participant
description: 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)
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Communication update with physician after participant contact
description: Pharmacist provides communication update (fax or electronic charting) with the participant's physician after contact with the participant
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Medication Counselling and Educational Support
description: Pharmacist provides medication related counselling and educational support to participant
arm group label: Control Group (Standard Pharmacist Care)
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Non-medication Counselling
description: Pharmacist provides non-medication related counselling and educational support to participant
arm group label: Control Group (Standard Pharmacist Care)
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Identification of drug interaction
description: Pharmacist identification of drug interaction related to medication for major depressive disorder and/or generalized anxiety
arm group label: Control Group (Standard Pharmacist Care)
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Identification of drug adverse effect
description: Pharmacist identification of adverse effect related to medication for major depressive disorder and/or generalized anxiety
arm group label: Control Group (Standard Pharmacist Care)
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Identification of severe deterioration
description: Pharmacist identification of participant severe deterioration (i.e. suicide attempt)
arm group label: Control Group (Standard Pharmacist Care)
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Pharmacist-to-physician recommendation for medication adjustment, change to alternative, add-on, or deprescribing
description: 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
arm group label: Control Group (Standard Pharmacist Care)
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
intervention type: Other
intervention name: Pharmacist initiated medication adjustment, change to alternative, add-on, or deprescribing
description: 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
arm group label: Intervention Group (Standard Pharmacist Care + Pharmacist Interventions)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yazid Al Hamarneh, BSc (Pharm), PhD, CDM
role: Principal Investigator
affiliation: University of Alberta
last name: Yazid Al Hamarneh, BSc (Pharm), PhD, CDM
phone: (780) 492-9608
email: yazid.alhamarneh@ualberta.ca
last name: Matthew Chow, BSc Pharm, PharmD
phone: (587) 999-0778
email: mchow1@ualberta.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Sponsor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major
mesh term: Anxiety Disorders
sharing ipd: No