<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/NCT02241863</url>
  </required_header>
  <id_info>
    <org_study_id>353</org_study_id>
    <nct_id>NCT02241863</nct_id>
  </id_info>
  <brief_title>The Effect of a Theory Based Educational Intervention on Medication Adherence to and Removes of Related Barriers in Patients With Bipolar Disorder</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Qazvin University Of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Qazvin University Of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite an increasing pharmacopoeia of effective medications for the treatment of bipolar&#xD;
      disorder, patient outcomes continue to be impacted by treatment adherence. Non-adherence to&#xD;
      treatments is also a major obstacle in translating efficacy in research settings into&#xD;
      effectiveness in clinical practice. Non-adherence with bipolar disorder (BD) medication&#xD;
      treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD&#xD;
      are multi-dimensional, and it has been suggested that a multifaceted intervention will be&#xD;
      more effective. The study is aimed to assess the effectiveness of a multifaceted intervention&#xD;
      on enhancing medications adherence in patients with bipolar disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Actual">September 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in Patient-reported medication Adherence to mood stabilizers</measure>
    <time_frame>changes from baseline, 1 Months and 6 months follow-up</time_frame>
    <description>The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to the mood stabilizers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma level of mood stabilizer</measure>
    <time_frame>Changes from baseline, 1 Months and 6 months after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in action planning</measure>
    <time_frame>Changes from baseline, 1 Months and 6 months after the intervention</time_frame>
    <description>A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in coping planning</measure>
    <time_frame>Changes from baseline, 1 Months and 6 months after the intervention</time_frame>
    <description>A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life</measure>
    <time_frame>Changes from baseline, 1 Months and 6 months after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in psychological predictors of medication adherence (intention, perceived behavioral control ,Self-monitoring and Behaviour Automaticity)</measure>
    <time_frame>Changes from baseline, 1 Months and 6 months after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S)</measure>
    <time_frame>Changes from baseline, 1 Months and 6 months after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Beliefs about Medicines Questionnaire (BMQ)</measure>
    <time_frame>Changes from baseline, 1 Months and 6 months after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Young Mania Rating Scale (YMRS)</measure>
    <time_frame>Changes from baseline, 1 Months and 6 months after the intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Montgomery Asberg Depression Rating Scale</measure>
    <time_frame>Changes from baseline, 1 Months and 6 months after the intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">270</enrollment>
  <condition>Patients With Bipolar Disorders</condition>
  <arm_group>
    <arm_group_label>Multifaceted intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients, their caregivers and family members will received the educational and motivational interventions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Multifaceted intervention</intervention_name>
    <description>Supportive intervention: care giver, health care providers, and patient's family members (including disease knowledge, treatment t of the disease, medication problems or adverse effects, the importance of medication adherence, supervision taking medications by the patients as prescribed). patient education: about the disease and treatment, consuming regularly the pills motivational intervening, self-monitoring planning. Patients will attend in five motivational interviewing sessions regularly to facilitating and engaging intrinsic motivation within the patients in order to change medication adherence behavior.</description>
    <arm_group_label>Multifaceted intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Routine counseling</intervention_name>
    <arm_group_label>Active Comparator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age ≥18 years&#xD;
&#xD;
          2. meeting DSM-IV criteria for bipolar I or II disorder&#xD;
&#xD;
          3. concurrently treated with a mood stabilizer&#xD;
&#xD;
          4. not currently in weekly or biweekly psychotherapy&#xD;
&#xD;
          5. Persian speaking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DSM-IV drug or alcohol misuse disorders (excluding nicotine),&#xD;
&#xD;
          -  pregnancy or planning pregnancy in the next year&#xD;
&#xD;
          -  requiring changing the drug or the dose of a mood stabilizer&#xD;
&#xD;
          -  evidence of severe DSM-IV borderline personality&#xD;
&#xD;
          -  Unable or unwilling to give written informed consent.&#xD;
&#xD;
          -  An organic cerebral cause for bipolar disorder-for example, multiple sclerosis or&#xD;
             stroke.&#xD;
&#xD;
          -  intellectual disability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Boostan</name>
      <address>
        <city>Ahvaz</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ebn'e Sina</name>
      <address>
        <city>Mashhad</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>22 Bahman Hospital</name>
      <address>
        <city>Qazvin</city>
        <zip>3419759811</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Psychiatry Center</name>
      <address>
        <city>Semnān</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shahid Mahallati</name>
      <address>
        <city>Tabriz</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iran Psychiatry</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maymanat</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roozbeh</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baharan</name>
      <address>
        <city>Zahedan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Beheshti</name>
      <address>
        <city>Zanjan</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>January 9, 2023</last_update_submitted>
  <last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Qazvin University Of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Amir H Pakpour</investigator_full_name>
    <investigator_title>Head of the Social Determinants of Health Research Center</investigator_title>
  </responsible_party>
  <keyword>bipolar disorders</keyword>
  <keyword>medication adherence</keyword>
  <keyword>psychological intervention</keyword>
  <keyword>multifaceted intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</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/NCT02241863
org study id: 353
nct id: NCT02241863
lead sponsor: 
has dmc: Yes
Despite an increasing pharmacopoeia of effective medications for the treatment of bipolar
      disorder, patient outcomes continue to be impacted by treatment adherence. Non-adherence to
      treatments is also a major obstacle in translating efficacy in research settings into
      effectiveness in clinical practice. Non-adherence with bipolar disorder (BD) medication
      treatment dramatically worsens outcomes. Reasons for non-adherence among individuals with BD
      are multi-dimensional, and it has been suggested that a multifaceted intervention will be
      more effective. The study is aimed to assess the effectiveness of a multifaceted intervention
      on enhancing medications adherence in patients with bipolar disorders.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: changes in Patient-reported medication Adherence to mood stabilizers
time frame: changes from baseline, 1 Months and 6 months follow-up
description: The Medication Adherence Report Scale (MARS-5) will be used for assessing medication adherence to the mood stabilizers
measure: Plasma level of mood stabilizer
time frame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in action planning
time frame: Changes from baseline, 1 Months and 6 months after the intervention
description: A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)
measure: Changes in coping planning
time frame: Changes from baseline, 1 Months and 6 months after the intervention
description: A self-reported questionnaire on five 5-point scale that ranged from 1 (strongly disagree) to 5 (strongly agree)
measure: Changes in quality of life
time frame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in psychological predictors of medication adherence (intention, perceived behavioral control ,Self-monitoring and Behaviour Automaticity)
time frame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in Global Impression for Bipolar Disorder Severity scale (CGI-BP-S)
time frame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in Beliefs about Medicines Questionnaire (BMQ)
time frame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in Young Mania Rating Scale (YMRS)
time frame: Changes from baseline, 1 Months and 6 months after the intervention
measure: Changes in Montgomery Asberg Depression Rating Scale
time frame: Changes from baseline, 1 Months and 6 months after the intervention
arm group label: Multifaceted intervention
arm group type: Experimental
description: Patients, their caregivers and family members will received the educational and motivational interventions
arm group label: Active Comparator
arm group type: Active Comparator
description: Usual Care The usual care group received routine counseling performed by the psychiatrist and nurses.
intervention type: Behavioral
intervention name: Multifaceted intervention
description: Supportive intervention: care giver, health care providers, and patient's family members (including disease knowledge, treatment t of the disease, medication problems or adverse effects, the importance of medication adherence, supervision taking medications by the patients as prescribed). patient education: about the disease and treatment, consuming regularly the pills motivational intervening, self-monitoring planning. Patients will attend in five motivational interviewing sessions regularly to facilitating and engaging intrinsic motivation within the patients in order to change medication adherence behavior.
arm group label: Multifaceted intervention
intervention type: Behavioral
intervention name: Routine counseling
arm group label: Active Comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Qazvin University Of Medical Sciences
investigator full name: Amir H Pakpour
investigator title: Head of the Social Determinants of Health Research Center
mesh term: Bipolar Disorder