xml: <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/NCT06019650</url>
    </required_header>
    <id_info>
      <org_study_id>ECMAP</org_study_id>
      <nct_id>NCT06019650</nct_id>
    </id_info>
    <brief_title>Culturally Adapted Suicide Prevention Intervention for Older Adults</brief_title>
    <acronym>ECMAP</acronym>
    <official_title>Elderly Culturally Adapted Manual Assisted Brief Psychological Therapy (E-CMAP) for Older Adults With Suicidal Ideation: An Exploratory Randomized Controlled Trial From Pakistan</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pakistan Institute of Living and Learning</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Pakistan Institute of Living and Learning</source>
    <oversight_info>
      <has_dmc>Yes</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>
        determine the efficacy of culturally adapted manual assisted brief psychological intervention&#xD;
        for older adults (E-CMAP) with suicidal ideation&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Suicide is a serious public health concern. Each year more than 800,000 people worldwide die&#xD;
        due to suicide. Most of these (79%) are in the low and middle-income countries (LMIC), with&#xD;
        an increased risk of suicide in ageing.&#xD;
  &#xD;
        Primary Objective: To assess the effectiveness of E-CMAP compared to Treatment as Usual (TAU)&#xD;
        as measured by reduction in suicidal ideation third month post-randomization with Beck Scale&#xD;
        for Suicidal ideation (BSI) (Beck &amp; Steer, 1991) Secondary outcomes: the two groups will be&#xD;
        compared on hopelessness, depression, quality of life, coping skills, participant&#xD;
        satisfaction, health/social care usage, and episodes of self-harm. All variables known to be&#xD;
        related to suicide risk.&#xD;
  &#xD;
        The study will be carried out in two stages. First stage will be cultural adaptation and&#xD;
        refinement of the intervention and second stage will be feasibility Randomised Control Trial&#xD;
        (RCT).&#xD;
  &#xD;
        Stage 1: In the first stage, the adaptation of the intervention for suicidal ideation in&#xD;
        older adults will be carried out by a group of experts including a master trainer, a&#xD;
        bilingual health expert, mental health professional potential user (i.e., older adults with&#xD;
        suicidal ideation), and a senior therapist through discussion groups.&#xD;
  &#xD;
        Stage 2: Feasibility randomized controlled trial (RCT) After adaptation, the intervention&#xD;
        will be tested in a multicenter RCT to determine the efficacy of culturally adapted manual&#xD;
        assisted brief psychological intervention for older adults/elderly (E-CMAP) with suicidal&#xD;
        ideation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Suicidal Ideation</measure>
      <time_frame>change in total scores from baseline to 3-month post randomization assessment</time_frame>
      <description>Participants suicidal ideation will be assessed using the Beck scale for suicidal ideation. Higher scores on the questionnaire indicate greater severeity of suicidal ideation (BSI) (Beck &amp; Steer, 1991)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Hopelessness</measure>
      <time_frame>change in total scores from baseline to 3-month post randomization assessment</time_frame>
      <description>Participants feelings of hopelessness will be assessed using the Beck Hopelessness Scale (BHS) (Beck &amp; Steer, 1988). Higher scores indicate greater severity of hopelessness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>change in total scores from baseline to 3-month post randomization assessment</time_frame>
      <description>Participants severity of depression will be assessed using the Beck Depression Inventory (BDI) (Beck, Ward, &amp; Mendelson, 1961). Higher scores indicate greater severity of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related Quality of Life</measure>
      <time_frame>change in total scores from baseline to 3-month post randomization assessment</time_frame>
      <description>Participants Health related quality of life will be assessed using the EQ-5D- 5L (Herdman et al., 2011). Higher scores indicate better health related quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coping Resource Inventory</measure>
      <time_frame>change in total scores from baseline to 3-month post randomization assessment</time_frame>
      <description>Participants coping skills will be assessed using the Coping Resource Inventory (CRI) (Martin &amp; Hammer, 1988). Higher scored indicate better coping skills.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Client Satisfaction Questionaire</measure>
      <time_frame>level of satisfaction at end of intervention i.e., 3-month post-randomization</time_frame>
      <description>Participant satisfaction with services will be assessed using the Client Satisfaction Questionnaire (CSQ) (Attkisson &amp; Zwick, 1982). Higher scores indicate greater level of satisfaction with the services.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Service Usage</measure>
      <time_frame>change in total scores from baseline to 3-month post randomization assessment</time_frame>
      <description>Service usage (including formal (GPs/ other doctor and informal sector such as faith healers/imams) will be assessed using client service receipt inventory (CSRI) (Beecham &amp; Knapp, 2001)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Episodes of Self-harm</measure>
      <time_frame>change in total scores from baseline to 3-month post randomization assessment</time_frame>
      <description>Episodes of Self-harm will be assessed using the Suicide attempt self -injury interview (SASII) (Linehan, Comtois, Brown, Heard, &amp; Wagner, 2006). This is the semi-structured instrument to assess diffeent aspects of episode of self-harm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Problem Solving Skills</measure>
      <time_frame>change in total scores from baseline to 3-month post randomization assessment</time_frame>
      <description>Participants problem Solving skills will be assessed using Problem solving Inventory (PSI) (Heppner &amp; Petersen, 1982). Higher scores indicate better problem solving skills.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">192</enrollment>
    <condition>Suicidal Ideation</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>C-MAP is a culturally adapted brief problem-focused therapy, based on the principles of CBT which has been adapted with permission from a self-help guide called &quot;Life after self-harm&quot;(Schmidt &amp; Davidson, 2004). This intervention includes evaluation of the self-harm attempt, crisis skills, problem-solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Routine Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>ECMAP</intervention_name>
      <description>The therapist will deliver 12-week training program comprised of 6 sessions at the participant's home/outpatient clinic depending upon the participants' choice within 3 months. The first two sessions will be offered weekly and then fortnightly.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          In the context of this study, suicidal ideation is defined as; &quot;Passive thoughts about&#xD;
          wanting to be dead or active thoughts about killing oneself, these thoughts may include&#xD;
          plan but not accompanied by preparatory behavior&quot; (Griffin et al., 2020)&#xD;
  &#xD;
            -  50 years and above&#xD;
  &#xD;
            -  Has recent history of experiencing suicidal ideation&#xD;
  &#xD;
            -  Participants living within the catchment area of the participating practices and&#xD;
               hospitals.&#xD;
  &#xD;
            -  Capacity to give informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unable to provide consent due to severe mental or physical illness.&#xD;
  &#xD;
            -  Unlikely to be available for outcome assessments (temporary residence)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Tayyeba Kiran, PhD</last_name>
      <phone>02135871845</phone>
      <email>tayyaba.kiran@pill.org.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sehrish Tofique, PhD fellow</last_name>
      <phone>02135871845</phone>
      <email>sehrish.tofique@pill.org.pk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Benazir Bhutto Hospital</name>
        <address>
          <city>Rawalpindi</city>
          <state>Punjab</state>
          <zip>203393</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Tayyeba Kiran, PhD</last_name>
        <email>tayyaba.kiran@pill.org.pk</email>
      </contact>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Husain N, Kiran T, Chaudhry IB, Williams C, Emsley R, Arshad U, Ansari MA, Bassett P, Bee P, Bhatia MR, Chew-Graham C, Husain MO, Irfan M, Khaliq A, Minhas FA, Naeem F, Naqvi H, Nizami AT, Noureen A, Panagioti M, Rasool G, Saeed S, Bukhari SQ, Tofique S, Zadeh ZF, Zafar SN, Chaudhry N. A culturally adapted manual-assisted problem-solving intervention (CMAP) for adults with a history of self-harm: a multi-centre randomised controlled trial. BMC Med. 2023 Jul 31;21(1):282. doi: 10.1186/s12916-023-02983-8.</citation>
      <PMID>37525207</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>suicidal ideation,</keyword>
    <keyword>self-harm</keyword>
    <keyword>older adult</keyword>
    <keyword>elderly</keyword>
    <keyword>ECMAP</keyword>
    <keyword>Pakistan</keyword>
    <keyword>LMIC</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Suicidal Ideation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019650
  org study id: ECMAP
  nct id: NCT06019650
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  determine the efficacy of culturally adapted manual assisted brief psychological intervention
        for older adults (E-CMAP) with suicidal ideation
  Suicide is a serious public health concern. Each year more than 800,000 people worldwide die
        due to suicide. Most of these (79%) are in the low and middle-income countries (LMIC), with
        an increased risk of suicide in ageing.
  
        Primary Objective: To assess the effectiveness of E-CMAP compared to Treatment as Usual (TAU)
        as measured by reduction in suicidal ideation third month post-randomization with Beck Scale
        for Suicidal ideation (BSI) (Beck & Steer, 1991) Secondary outcomes: the two groups will be
        compared on hopelessness, depression, quality of life, coping skills, participant
        satisfaction, health/social care usage, and episodes of self-harm. All variables known to be
        related to suicide risk.
  
        The study will be carried out in two stages. First stage will be cultural adaptation and
        refinement of the intervention and second stage will be feasibility Randomised Control Trial
        (RCT).
  
        Stage 1: In the first stage, the adaptation of the intervention for suicidal ideation in
        older adults will be carried out by a group of experts including a master trainer, a
        bilingual health expert, mental health professional potential user (i.e., older adults with
        suicidal ideation), and a senior therapist through discussion groups.
  
        Stage 2: Feasibility randomized controlled trial (RCT) After adaptation, the intervention
        will be tested in a multicenter RCT to determine the efficacy of culturally adapted manual
        assisted brief psychological intervention for older adults/elderly (E-CMAP) with suicidal
        ideation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Suicidal Ideation
  time frame: change in total scores from baseline to 3-month post randomization assessment
  description: Participants suicidal ideation will be assessed using the Beck scale for suicidal ideation. Higher scores on the questionnaire indicate greater severeity of suicidal ideation (BSI) (Beck & Steer, 1991)
  measure: Hopelessness
  time frame: change in total scores from baseline to 3-month post randomization assessment
  description: Participants feelings of hopelessness will be assessed using the Beck Hopelessness Scale (BHS) (Beck & Steer, 1988). Higher scores indicate greater severity of hopelessness.
  measure: Depression
  time frame: change in total scores from baseline to 3-month post randomization assessment
  description: Participants severity of depression will be assessed using the Beck Depression Inventory (BDI) (Beck, Ward, & Mendelson, 1961). Higher scores indicate greater severity of depression.
  measure: Health-related Quality of Life
  time frame: change in total scores from baseline to 3-month post randomization assessment
  description: Participants Health related quality of life will be assessed using the EQ-5D- 5L (Herdman et al., 2011). Higher scores indicate better health related quality of life
  measure: Coping Resource Inventory
  time frame: change in total scores from baseline to 3-month post randomization assessment
  description: Participants coping skills will be assessed using the Coping Resource Inventory (CRI) (Martin & Hammer, 1988). Higher scored indicate better coping skills.
  measure: Client Satisfaction Questionaire
  time frame: level of satisfaction at end of intervention i.e., 3-month post-randomization
  description: Participant satisfaction with services will be assessed using the Client Satisfaction Questionnaire (CSQ) (Attkisson & Zwick, 1982). Higher scores indicate greater level of satisfaction with the services.
  measure: Service Usage
  time frame: change in total scores from baseline to 3-month post randomization assessment
  description: Service usage (including formal (GPs/ other doctor and informal sector such as faith healers/imams) will be assessed using client service receipt inventory (CSRI) (Beecham & Knapp, 2001)
  measure: Episodes of Self-harm
  time frame: change in total scores from baseline to 3-month post randomization assessment
  description: Episodes of Self-harm will be assessed using the Suicide attempt self -injury interview (SASII) (Linehan, Comtois, Brown, Heard, & Wagner, 2006). This is the semi-structured instrument to assess diffeent aspects of episode of self-harm
  measure: Problem Solving Skills
  time frame: change in total scores from baseline to 3-month post randomization assessment
  description: Participants problem Solving skills will be assessed using Problem solving Inventory (PSI) (Heppner & Petersen, 1982). Higher scores indicate better problem solving skills.
  arm group label: Intervention
  arm group type: Experimental
  description: C-MAP is a culturally adapted brief problem-focused therapy, based on the principles of CBT which has been adapted with permission from a self-help guide called "Life after self-harm"(Schmidt & Davidson, 2004). This intervention includes evaluation of the self-harm attempt, crisis skills, problem-solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies.
  arm group label: Standard Routine Care
  arm group type: No Intervention
  description: Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources
  intervention type: Behavioral
  intervention name: ECMAP
  description: The therapist will deliver 12-week training program comprised of 6 sessions at the participant's home/outpatient clinic depending upon the participants' choice within 3 months. The first two sessions will be offered weekly and then fortnightly.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Tayyeba Kiran, PhD
  phone: 02135871845
  email: tayyaba.kiran@pill.org.pk
  last name: Sehrish Tofique, PhD fellow
  phone: 02135871845
  email: sehrish.tofique@pill.org.pk
  facility: 
  contact: 
  country: Pakistan
  citation: Husain N, Kiran T, Chaudhry IB, Williams C, Emsley R, Arshad U, Ansari MA, Bassett P, Bee P, Bhatia MR, Chew-Graham C, Husain MO, Irfan M, Khaliq A, Minhas FA, Naeem F, Naqvi H, Nizami AT, Noureen A, Panagioti M, Rasool G, Saeed S, Bukhari SQ, Tofique S, Zadeh ZF, Zafar SN, Chaudhry N. A culturally adapted manual-assisted problem-solving intervention (CMAP) for adults with a history of self-harm: a multi-centre randomised controlled trial. BMC Med. 2023 Jul 31;21(1):282. doi: 10.1186/s12916-023-02983-8.
  PMID: 37525207
  responsible party type: Sponsor
  mesh term: Suicidal Ideation
  sharing ipd: No