<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/NCT02187380</url>
  </required_header>
  <id_info>
    <org_study_id>B32220109082</org_study_id>
    <secondary_id>s52518</secondary_id>
    <nct_id>NCT02187380</nct_id>
  </id_info>
  <brief_title>Studying the Impact of Medication Counselling by Community Pharmacists in Patients Starting a Treatment With Antidepressants</brief_title>
  <acronym>SIMCA</acronym>
  <official_title>Studying the Impact of Medication Counselling by Community Pharmacists in Patients Starting a Treatment With Antidepressants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the SIMCA study was to analyse the impact of structured medication&#xD;
      counselling by community pharmacists on medication adherence, economic, clinical and&#xD;
      humanistic outcomes of depressed primary care patients who started a new treatment with&#xD;
      antidepressants.&#xD;
&#xD;
      A clustered RCT was set up in the Surplus Network, a pharmacy chain in Flanders, Belgium. At&#xD;
      the time of the start of the study, the Surplus Network included 97 pharmacies, in all five&#xD;
      Flemish provinces, including Brussels. During pre-trial meetings, all pharmacists were&#xD;
      informed about the SIMCA-study and instructed how to approach eligible patients.&#xD;
&#xD;
      Randomisation was obtained at the pharmacy level by a computerized random-number generator,&#xD;
      following a permuted block design (1:1). The Surplus Network contains a number of local&#xD;
      pharmacy chains; stratiﬁcation was used to ensure equal distribution within local pharmacy&#xD;
      chains.&#xD;
&#xD;
      Pharmacists in the intervention group were trained in communication skills related to&#xD;
      depression treatment counselling in groups of no more than 10 participants over a single day.&#xD;
      In total, 10 training days were scheduled between November and December, 2010.&#xD;
&#xD;
      Patients were eligible for inclusion in the study if they started using at least one&#xD;
      antidepressant drug, if they were at least 18 years old, if they were able to understand and&#xD;
      complete Dutch questionnaires and if they could be reached by telephone for follow-up.&#xD;
      &quot;Starting&quot; was defined as not having been prescribed antidepressants over the last six&#xD;
      months, which was checked in the pharmacy records. If the patient gave verbal consent to the&#xD;
      pharmacist, to be contacted by the research team, the patient was provided with written and&#xD;
      oral information about the SIMCA project and a consent form. At the same time an automatic&#xD;
      e-mail was generated from the pharmacy software to inform the research team about the&#xD;
      patient's willingness to be contacted about the study. The patient was contacted by the&#xD;
      research team, as soon as possible to give more information about the study, to ask for&#xD;
      informed consent and to schedule a first telephone survey interview. If the patient wished to&#xD;
      participate, he/she completed the consent form, and sent it back with the included&#xD;
      postage-paid envelope addressed to the research team. Upon receipt of the consent form, the&#xD;
      recruited patient's prescribing doctor was contacted and asked to complete and return a brief&#xD;
      questionnaire to provide the diagnosis and its severity related to prescribing&#xD;
      antidepressants.&#xD;
&#xD;
      Telephone survey interviews based on validated scales were used to collect data at the start&#xD;
      of treatment (as close as possible to the time of recruitment), after one month, three months&#xD;
      and six months of treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2010</start_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>1 month after start of antidepressants treatment</time_frame>
    <description>Medication adherence measured by the MMAS-8</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>3 months after start of antidepressants treatment</time_frame>
    <description>Medication adherence measured by the MMAS-8</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>6 months after start of antidepressants treatment</time_frame>
    <description>Medication adherence measured by the MMAS-8</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Economic outcomes</measure>
    <time_frame>at the start of antidepressants treatment</time_frame>
    <description>Economic outcomes are measured by the WPAI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic outcomes</measure>
    <time_frame>1 month after the start of antidepressants treatment</time_frame>
    <description>Economic outcomes are measured by the WPAI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic outcomes</measure>
    <time_frame>3 months after the start of antidepressants treatment</time_frame>
    <description>Economic outcomes are measured by the WPAI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Economic outcomes</measure>
    <time_frame>6 months after the start of antidepressants treatment</time_frame>
    <description>Economic outcomes are measured by the WPAI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes</measure>
    <time_frame>at the start of antidepressants treatment</time_frame>
    <description>Clinical outcomes are measured by the HADS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes</measure>
    <time_frame>1 month after the start of antidepressants treatment</time_frame>
    <description>Clinical outcomes are measured by the HADS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes</measure>
    <time_frame>3 months after the start of antidepressants treatment</time_frame>
    <description>Clinical outcomes are measured by the HADS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes</measure>
    <time_frame>6 months after the start of antidepressants treatment</time_frame>
    <description>Clinical outcomes are measured by the HADS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beliefs about medicines</measure>
    <time_frame>At the start of antidepressants treatment</time_frame>
    <description>Patients' beliefs about medicines are measured by the BMQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beliefs about medicines</measure>
    <time_frame>1 month after the start of antidepressants treatment</time_frame>
    <description>Patients' beliefs about medicines are measured by the BMQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beliefs about medicines</measure>
    <time_frame>3 months after the start of antidepressants treatment</time_frame>
    <description>Patients' beliefs about medicines are measured by the BMQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beliefs about medicines</measure>
    <time_frame>6 months after the start of antidepressants treatment</time_frame>
    <description>Patients' beliefs about medicines are measured by the BMQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the pharmacist</measure>
    <time_frame>At the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the pharmacist is measured by the SWiP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the pharmacist</measure>
    <time_frame>1 month after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the pharmacist is measured by the SWiP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the pharmacist</measure>
    <time_frame>3 months after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the pharmacist is measured by the SWiP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the pharmacist</measure>
    <time_frame>6 months after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the pharmacist is measured by the SWiP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feelings about side effects</measure>
    <time_frame>1 month after the start of antidepressants treatment</time_frame>
    <description>Patients' feelings about side effects of antidepressants are measured by the FSE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feelings about side effects</measure>
    <time_frame>3 months after the start of antidepressants treatment</time_frame>
    <description>Patients' feelings about side effects of antidepressants are measured by the FSE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feelings about side effects</measure>
    <time_frame>6 months after the start of antidepressants treatment</time_frame>
    <description>Patients' feelings about side effects of antidepressants are measured by the FSE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with treatment</measure>
    <time_frame>1 month after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with antidepressants treatment is measured by the SWT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with treatment</measure>
    <time_frame>3 months after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with antidepressants treatment is measured by the SWT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with treatment</measure>
    <time_frame>6 months after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with antidepressants treatment is measured by the SWT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with information regarding treatment</measure>
    <time_frame>At the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with information regarding treatment</measure>
    <time_frame>1 month after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with information regarding treatment</measure>
    <time_frame>3 months after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with information regarding treatment</measure>
    <time_frame>6 months after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with information regarding side effects</measure>
    <time_frame>At the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with information regarding side effects</measure>
    <time_frame>1 month after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with information regarding side effects</measure>
    <time_frame>3 months after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with information regarding side effects</measure>
    <time_frame>6 months after the start of antidepressants treatment</time_frame>
    <description>Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>At the start of antidepressants treatment</time_frame>
    <description>Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>1 month after the start of antidepressants treatment</time_frame>
    <description>Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>3 months after the start of antidepressants treatment</time_frame>
    <description>Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>6 months after the start of antidepressants treatment</time_frame>
    <description>Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment and satisfaction</measure>
    <time_frame>At the start of antidepressants treatment</time_frame>
    <description>Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment and satisfaction</measure>
    <time_frame>1 month after the start of antidepressants treatment</time_frame>
    <description>Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment and satisfaction</measure>
    <time_frame>3 months after the start of antidepressants treatment</time_frame>
    <description>Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment and satisfaction</measure>
    <time_frame>6 months after the start of antidepressants treatment</time_frame>
    <description>Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">223</enrollment>
  <condition>Depression</condition>
  <condition>Antidepressant</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Pharmacists received no depression training, delivered usual care to patients starting a new treatment with depression.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <description>Pharmacists received a depression training day and provided structured medication counselling to patients starting a new treatment with antidepressants</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        primary care patients with a new prescription for antidepressants in Flanders, Belgium.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 18 years old&#xD;
&#xD;
          -  able to understand and complete Dutch questionnaires&#xD;
&#xD;
          -  could be reached by telephone for follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  used antidepressants over the last six months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sophie Liekens, M Psy</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KU Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Sophie Liekens</investigator_full_name>
    <investigator_title>M Psy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- 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/NCT02187380
org study id: B32220109082
secondary id: s52518
nct id: NCT02187380
lead sponsor: 
has dmc: No
The objective of the SIMCA study was to analyse the impact of structured medication
      counselling by community pharmacists on medication adherence, economic, clinical and
      humanistic outcomes of depressed primary care patients who started a new treatment with
      antidepressants.

      A clustered RCT was set up in the Surplus Network, a pharmacy chain in Flanders, Belgium. At
      the time of the start of the study, the Surplus Network included 97 pharmacies, in all five
      Flemish provinces, including Brussels. During pre-trial meetings, all pharmacists were
      informed about the SIMCA-study and instructed how to approach eligible patients.

      Randomisation was obtained at the pharmacy level by a computerized random-number generator,
      following a permuted block design (1:1). The Surplus Network contains a number of local
      pharmacy chains; stratiﬁcation was used to ensure equal distribution within local pharmacy
      chains.

      Pharmacists in the intervention group were trained in communication skills related to
      depression treatment counselling in groups of no more than 10 participants over a single day.
      In total, 10 training days were scheduled between November and December, 2010.

      Patients were eligible for inclusion in the study if they started using at least one
      antidepressant drug, if they were at least 18 years old, if they were able to understand and
      complete Dutch questionnaires and if they could be reached by telephone for follow-up.
      "Starting" was defined as not having been prescribed antidepressants over the last six
      months, which was checked in the pharmacy records. If the patient gave verbal consent to the
      pharmacist, to be contacted by the research team, the patient was provided with written and
      oral information about the SIMCA project and a consent form. At the same time an automatic
      e-mail was generated from the pharmacy software to inform the research team about the
      patient's willingness to be contacted about the study. The patient was contacted by the
      research team, as soon as possible to give more information about the study, to ask for
      informed consent and to schedule a first telephone survey interview. If the patient wished to
      participate, he/she completed the consent form, and sent it back with the included
      postage-paid envelope addressed to the research team. Upon receipt of the consent form, the
      recruited patient's prescribing doctor was contacted and asked to complete and return a brief
      questionnaire to provide the diagnosis and its severity related to prescribing
      antidepressants.

      Telephone survey interviews based on validated scales were used to collect data at the start
      of treatment (as close as possible to the time of recruitment), after one month, three months
      and six months of treatment.
observational model: Case-Control
time perspective: Prospective
measure: Medication adherence
time frame: 1 month after start of antidepressants treatment
description: Medication adherence measured by the MMAS-8
measure: Medication adherence
time frame: 3 months after start of antidepressants treatment
description: Medication adherence measured by the MMAS-8
measure: Medication adherence
time frame: 6 months after start of antidepressants treatment
description: Medication adherence measured by the MMAS-8
measure: Economic outcomes
time frame: at the start of antidepressants treatment
description: Economic outcomes are measured by the WPAI
measure: Economic outcomes
time frame: 1 month after the start of antidepressants treatment
description: Economic outcomes are measured by the WPAI
measure: Economic outcomes
time frame: 3 months after the start of antidepressants treatment
description: Economic outcomes are measured by the WPAI
measure: Economic outcomes
time frame: 6 months after the start of antidepressants treatment
description: Economic outcomes are measured by the WPAI
measure: Clinical outcomes
time frame: at the start of antidepressants treatment
description: Clinical outcomes are measured by the HADS
measure: Clinical outcomes
time frame: 1 month after the start of antidepressants treatment
description: Clinical outcomes are measured by the HADS
measure: Clinical outcomes
time frame: 3 months after the start of antidepressants treatment
description: Clinical outcomes are measured by the HADS
measure: Clinical outcomes
time frame: 6 months after the start of antidepressants treatment
description: Clinical outcomes are measured by the HADS
measure: Beliefs about medicines
time frame: At the start of antidepressants treatment
description: Patients' beliefs about medicines are measured by the BMQ
measure: Beliefs about medicines
time frame: 1 month after the start of antidepressants treatment
description: Patients' beliefs about medicines are measured by the BMQ
measure: Beliefs about medicines
time frame: 3 months after the start of antidepressants treatment
description: Patients' beliefs about medicines are measured by the BMQ
measure: Beliefs about medicines
time frame: 6 months after the start of antidepressants treatment
description: Patients' beliefs about medicines are measured by the BMQ
measure: Satisfaction with the pharmacist
time frame: At the start of antidepressants treatment
description: Patients' satisfaction with the pharmacist is measured by the SWiP
measure: Satisfaction with the pharmacist
time frame: 1 month after the start of antidepressants treatment
description: Patients' satisfaction with the pharmacist is measured by the SWiP
measure: Satisfaction with the pharmacist
time frame: 3 months after the start of antidepressants treatment
description: Patients' satisfaction with the pharmacist is measured by the SWiP
measure: Satisfaction with the pharmacist
time frame: 6 months after the start of antidepressants treatment
description: Patients' satisfaction with the pharmacist is measured by the SWiP
measure: Feelings about side effects
time frame: 1 month after the start of antidepressants treatment
description: Patients' feelings about side effects of antidepressants are measured by the FSE
measure: Feelings about side effects
time frame: 3 months after the start of antidepressants treatment
description: Patients' feelings about side effects of antidepressants are measured by the FSE
measure: Feelings about side effects
time frame: 6 months after the start of antidepressants treatment
description: Patients' feelings about side effects of antidepressants are measured by the FSE
measure: Satisfaction with treatment
time frame: 1 month after the start of antidepressants treatment
description: Patients' satisfaction with antidepressants treatment is measured by the SWT
measure: Satisfaction with treatment
time frame: 3 months after the start of antidepressants treatment
description: Patients' satisfaction with antidepressants treatment is measured by the SWT
measure: Satisfaction with treatment
time frame: 6 months after the start of antidepressants treatment
description: Patients' satisfaction with antidepressants treatment is measured by the SWT
measure: Satisfaction with information regarding treatment
time frame: At the start of antidepressants treatment
description: Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE
measure: Satisfaction with information regarding treatment
time frame: 1 month after the start of antidepressants treatment
description: Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE
measure: Satisfaction with information regarding treatment
time frame: 3 months after the start of antidepressants treatment
description: Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE
measure: Satisfaction with information regarding treatment
time frame: 6 months after the start of antidepressants treatment
description: Patients' satisfaction with the received information regarding antidepressants treatment was measured by a sub-scale of the PS-CaTE
measure: Satisfaction with information regarding side effects
time frame: At the start of antidepressants treatment
description: Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE
measure: Satisfaction with information regarding side effects
time frame: 1 month after the start of antidepressants treatment
description: Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE
measure: Satisfaction with information regarding side effects
time frame: 3 months after the start of antidepressants treatment
description: Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE
measure: Satisfaction with information regarding side effects
time frame: 6 months after the start of antidepressants treatment
description: Patients' satisfaction with the received information regarding side effects of antidepressants was measured by a sub-scale of the PS-CaTE
measure: Health-related quality of life
time frame: At the start of antidepressants treatment
description: Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D
measure: Health-related quality of life
time frame: 1 month after the start of antidepressants treatment
description: Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D
measure: Health-related quality of life
time frame: 3 months after the start of antidepressants treatment
description: Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D
measure: Health-related quality of life
time frame: 6 months after the start of antidepressants treatment
description: Patients' health-related quality of life is measured by the EQ visual analogue scale from the EQ-5D
measure: Enjoyment and satisfaction
time frame: At the start of antidepressants treatment
description: Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q
measure: Enjoyment and satisfaction
time frame: 1 month after the start of antidepressants treatment
description: Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q
measure: Enjoyment and satisfaction
time frame: 3 months after the start of antidepressants treatment
description: Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q
measure: Enjoyment and satisfaction
time frame: 6 months after the start of antidepressants treatment
description: Patients' enjoyment and satisfaction is measured by the short-form of the Q-LES-Q
arm group label: Control group
description: Pharmacists received no depression training, delivered usual care to patients starting a new treatment with depression.
arm group label: Intervention group
description: Pharmacists received a depression training day and provided structured medication counselling to patients starting a new treatment with antidepressants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sophie Liekens, M Psy
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Sophie Liekens
investigator title: M Psy
mesh term: Depression