<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/NCT02968667</url>
  </required_header>
  <id_info>
    <org_study_id>FakeehCMS</org_study_id>
    <nct_id>NCT02968667</nct_id>
  </id_info>
  <brief_title>The Impact of a Helplessness and Recovery of an Empowerment Intervention on People Diagnosed With Schizophrenia: Findings From a Randomized Controlled Trial</brief_title>
  <official_title>The Effectiveness of Hopelessness and Helplessness on Recovery Rate Among People Diagnosed With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fakeeh College for Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fakeeh College for Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized controlled trial was conducted from November 2015 and May 2016 with 112&#xD;
      participants of people diagnosed with schizophrenia. Participants aged 18 years or older with&#xD;
      Diagnostic Statistical Manual (DSM-V) schizophrenia or schizoaffective disorder from&#xD;
      outpatient mental health clinics in Jordan, were randomly assigned participants either to&#xD;
      receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment&#xD;
      as usual (TAU) (intervention, n = 56), or TAU (control, n = 56). Participants were assessed&#xD;
      at baseline, immediately post-intervention (post-treatment1) and at three months follow-up.&#xD;
      The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS&#xD;
      were psychiatric symptoms, recovery rate and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled trial was conducted from November 2015 and May 2016 with 112&#xD;
      participants of people diagnosed with schizophrenia. Participants aged 18 years or older with&#xD;
      DSM-V schizophrenia or schizoaffective disorder from outpatient mental health clinics in&#xD;
      Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of&#xD;
      intervention with face to face discussion, and treatment as usual [TAU] (intervention, n =&#xD;
      56), or TAU (control, n = 56). Participants were assessed at baseline, immediately&#xD;
      post-intervention (post-treatment1) and at three months follow-up. The primary outcome&#xD;
      measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric&#xD;
      symptoms, recovery rate and quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2015</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</primary_completion_date>
  <phase>Phase 2</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>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Learned Helplessness</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychiatric symptoms</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recovery assessment scale</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Empowerment level</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Psychotic Disorders</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group received 6 weeks of empowerment program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Medications</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Empowerment</intervention_name>
    <description>6 weeks of empowerment program and supported face to face discussion</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult aged 16 years or more&#xD;
&#xD;
          -  Able to read and write in an Arabic&#xD;
&#xD;
          -  Able to consent&#xD;
&#xD;
          -  Diagnosed with schizophrenia&#xD;
&#xD;
          -  Volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Learning disability&#xD;
&#xD;
          -  Not able to read or write&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fakeeh College for Medical Sciences</investigator_affiliation>
    <investigator_full_name>Abd Alhadi Hasan</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Psychotic Disorders</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/NCT02968667
org study id: FakeehCMS
nct id: NCT02968667
lead sponsor: 
has dmc: No
A randomized controlled trial was conducted from November 2015 and May 2016 with 112
      participants of people diagnosed with schizophrenia. Participants aged 18 years or older with
      Diagnostic Statistical Manual (DSM-V) schizophrenia or schizoaffective disorder from
      outpatient mental health clinics in Jordan, were randomly assigned participants either to
      receive 6 weeks of a booklet form of intervention with face to face discussion, and treatment
      as usual (TAU) (intervention, n = 56), or TAU (control, n = 56). Participants were assessed
      at baseline, immediately post-intervention (post-treatment1) and at three months follow-up.
      The primary outcome measure was change in helplessness score . Secondary outcomes for PDwS
      were psychiatric symptoms, recovery rate and quality of life.
A randomized controlled trial was conducted from November 2015 and May 2016 with 112
      participants of people diagnosed with schizophrenia. Participants aged 18 years or older with
      DSM-V schizophrenia or schizoaffective disorder from outpatient mental health clinics in
      Jordan, were randomly assigned participants either to receive 6 weeks of a booklet form of
      intervention with face to face discussion, and treatment as usual [TAU] (intervention, n =
      56), or TAU (control, n = 56). Participants were assessed at baseline, immediately
      post-intervention (post-treatment1) and at three months follow-up. The primary outcome
      measure was change in helplessness score . Secondary outcomes for PDwS were psychiatric
      symptoms, recovery rate and quality of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Modified Learned Helplessness
time frame: Up to 6 months
description: Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
measure: Psychiatric symptoms
time frame: Up to 6 months
description: Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
measure: recovery assessment scale
time frame: Up to 6 months
description: Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
measure: Empowerment level
time frame: Up to 6 months
description: Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
measure: Quality of life
time frame: Up to 6 months
description: Outcome was measured at baseline (November) and immediately post intervention (February) and at three months follow up (May)
arm group label: Intervention
arm group type: Experimental
description: Intervention group received 6 weeks of empowerment program
arm group label: Treatment as usual
arm group type: No Intervention
description: Medications
intervention type: Behavioral
intervention name: Empowerment
description: 6 weeks of empowerment program and supported face to face discussion
arm group label: Intervention
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Fakeeh College for Medical Sciences
investigator full name: Abd Alhadi Hasan
investigator title: Assistant professor
mesh term: Schizophrenia
mesh term: Psychotic Disorders