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/NCT06019689</url>
    </required_header>
    <id_info>
      <org_study_id>PILL-CAMI</org_study_id>
      <nct_id>NCT06019689</nct_id>
    </id_info>
    <brief_title>Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention</brief_title>
    <acronym>CAMI</acronym>
    <official_title>Exploratory Study of a Culturally Adapted Manual-assisted Problem-solving Mobile Based Intervention (CAMI) for Suicidal Ideation: A Multicentre, Two Arm, 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 feasibility, acceptability and efficacy of an adapted digitally delivered CMAP&#xD;
        (CMAP-SI) intervention (CAMI) compared to treatment as usual (TAU) for patients presenting&#xD;
        with suicidal ideation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The reported suicide rates in South Asia are high compared to the global average. These&#xD;
        figures are likely to be an underestimate since suicide data from many LMICs such as Pakistan&#xD;
        is lacking and what is available is not reliable (Jordans et al., 2014). According to an&#xD;
        estimate, 5,000 to 7,000 suicides take place each year in Pakistan (Hafeez, 2016) and at&#xD;
        least 10 to 20 suicide attempts happen for every suicide.&#xD;
  &#xD;
        Mobile health is a novel and emerging field in psychiatric and psychological care and&#xD;
        treatment of mental health difficulties, it involves the use of telecommunications to provide&#xD;
        health care, support and intervention from a distance.&#xD;
  &#xD;
        The proposed study will be carried out in two phases; Stage 1) adaptation of an already&#xD;
        existing culturally adapted manual assisted problem solving intervention (CMAP) for patients&#xD;
        with suicidal ideation presenting to primary care in Pakistan and further adaptation into a&#xD;
        digital intervention.&#xD;
  &#xD;
        Stage 2) feasibility Randomised Control trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 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>
      <intervention_model_description>multicenter exploratory RCT</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Researcher conducting assessments will be masked to participant group allocation. This will be achieved by briefing participants and research staff in advance around maintaining masking.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Suicide Ideation .</measure>
      <time_frame>Change in scores from baseline to 3 and 6-month post-randomization</time_frame>
      <description>The BSI is a 19-item self-report instrument for detecting and measuring the current intensity of the patient's attitudes, behaviors and specificity of a patient's thoughts to die by suicide during the past week. Higher scores indicate greater severity of suicidal ideation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>Change in scores from baseline to 3 and 6-month post-randomization</time_frame>
      <description>Beck Depression Inventory (BDI), which is a 21-item scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hopelessness</measure>
      <time_frame>Change in scores from baseline to 3 and 6-month post-randomization</time_frame>
      <description>Beck Hopelessness Scale (BHS) (Beck, A and Steer, R, 1988) is a self-report instrument designed to measure three aspects of hopelessness: feelings about the future, loss of motivation and expectations during the past week. Higher scores indicate greater severity of hopelessness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>Change in scores from baseline to 3 and 6-month post-randomization</time_frame>
      <description>Quality of life-EuroQoL (EQ-5D) (Brooks, R. and Group, E., 1996): This is a standardised instrument to measure health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Higher scores indicate better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Client Service Receipt Inventory</measure>
      <time_frame>Change in scores from baseline to 3 and 6-month post-randomization</time_frame>
      <description>Detailed description of the use of health services will be collected using the Client Service Receipt Inventory (CSRI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Client Satisfaction Questionnaire</measure>
      <time_frame>level of satisfaction at end of intervention i.e., 3-month post-randomization</time_frame>
      <description>The Client Satisfaction Questionnaire (Attkisson, Zwick, &amp; planning, 1982) is an 8 item measure of client satisfaction with services. Higher scores indicate greater satisfaction with the services received.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Suicidal Ideation</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Digitally delivered CMAP intervention through App. CMAP is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of Cognitive behavioral therapy (CBT).</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 providing standard routine care to participant patients. Participants receiving an initial assessment along with TAU as ascertained by their treating doctor at the hospital or their primary care physician (general practitioner (GP)</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>CAMI</intervention_name>
      <description>Culturally Adapted manual-assisted problem solving training based Mobile Intervention (CAMI) for Suicidal Ideation. CMAP is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of Cognitive behavioral therapy (CBT). This intervention is an evaluation of suicidal ideation, crisis skills, problem-solving and CBT techniques to manage emotions, negative thinking, interpersonal relationships and relapse prevention strategies.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Individuals (aged 18-64) screened and identified as having suicidal ideation&#xD;
  &#xD;
            -  Able to give written informed consent&#xD;
  &#xD;
            -  Living within the catchment areas of participating hospitals&#xD;
  &#xD;
            -  Have a smart phone and able to operate it&#xD;
  &#xD;
            -  Able to read and speak Urdu&#xD;
  &#xD;
            -  Not requiring in-patient psychiatric treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Presence of a diagnosed physical or intellectual disability as it can prevent&#xD;
               individuals from engaging with the intervention. This will be assessed by the research&#xD;
               team at screening stage. Any disabilities will be identified by a relevant clinician&#xD;
               (e.g. Psychiatrist).&#xD;
  &#xD;
            -  Temporary resident unlikely to be available for follow-up (b) participants with a&#xD;
               diagnosis of DSM-IV mental disorder due to general medical condition or substance&#xD;
               misuse, dementia, delirium, alcohol and drug dependence, schizophrenia, or bipolar&#xD;
               disorder.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nasim Chaudhry, MRC Psych, FRC Psych</last_name>
      <role>Principal Investigator</role>
      <affiliation>Pakistan Institute of Living and Learning</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nasim Chaudhry, MRC Psych, FRC Psych, MD</last_name>
      <phone>02135871845</phone>
      <email>nasim.chaudhry@pill.org.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tayyeba Kiran, PhD</last_name>
      <phone>03328262142</phone>
      <email>tayyaba.kiran@pill.org.pk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Quetta Site</name>
        <address>
          <city>Quetta</city>
          <state>Balochistan</state>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Peshawar Site</name>
        <address>
          <city>Peshawar</city>
          <state>KPK</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>umair</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Lahore Site</name>
        <address>
          <city>Lahore</city>
          <state>Punjab</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Ayesha Khaliq, MS</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Multan Site</name>
        <address>
          <city>Multan</city>
          <state>Punjab</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Zehra Nigah, Mphil</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Rawalpindi Site</name>
        <address>
          <city>Rawalpindi</city>
          <state>Punjab</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Samia Shahid, BS</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hyderabad Site</name>
        <address>
          <city>Hyderabad</city>
          <state>Sindh</state>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Faster Gill</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Karachi Site</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <zip>75350</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Sehrish Tofique</last_name>
        <phone>03242939563</phone>
      </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 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 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>self-harm</keyword>
    <keyword>suicidal ideation</keyword>
    <keyword>Mobile intervention</keyword>
    <keyword>cultural adaptation</keyword>
    <keyword>Pakistan</keyword>
    <keyword>LMIC</keyword>
    <keyword>Problem-solving</keyword>
    <keyword>CBT</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/NCT06019689
  org study id: PILL-CAMI
  nct id: NCT06019689
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Determine the feasibility, acceptability and efficacy of an adapted digitally delivered CMAP
        (CMAP-SI) intervention (CAMI) compared to treatment as usual (TAU) for patients presenting
        with suicidal ideation.
  The reported suicide rates in South Asia are high compared to the global average. These
        figures are likely to be an underestimate since suicide data from many LMICs such as Pakistan
        is lacking and what is available is not reliable (Jordans et al., 2014). According to an
        estimate, 5,000 to 7,000 suicides take place each year in Pakistan (Hafeez, 2016) and at
        least 10 to 20 suicide attempts happen for every suicide.
  
        Mobile health is a novel and emerging field in psychiatric and psychological care and
        treatment of mental health difficulties, it involves the use of telecommunications to provide
        health care, support and intervention from a distance.
  
        The proposed study will be carried out in two phases; Stage 1) adaptation of an already
        existing culturally adapted manual assisted problem solving intervention (CMAP) for patients
        with suicidal ideation presenting to primary care in Pakistan and further adaptation into a
        digital intervention.
  
        Stage 2) feasibility Randomised Control trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: multicenter exploratory RCT
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: Researcher conducting assessments will be masked to participant group allocation. This will be achieved by briefing participants and research staff in advance around maintaining masking.
  measure: Suicide Ideation .
  time frame: Change in scores from baseline to 3 and 6-month post-randomization
  description: The BSI is a 19-item self-report instrument for detecting and measuring the current intensity of the patient's attitudes, behaviors and specificity of a patient's thoughts to die by suicide during the past week. Higher scores indicate greater severity of suicidal ideation
  measure: Depression
  time frame: Change in scores from baseline to 3 and 6-month post-randomization
  description: Beck Depression Inventory (BDI), which is a 21-item scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
  measure: Hopelessness
  time frame: Change in scores from baseline to 3 and 6-month post-randomization
  description: Beck Hopelessness Scale (BHS) (Beck, A and Steer, R, 1988) is a self-report instrument designed to measure three aspects of hopelessness: feelings about the future, loss of motivation and expectations during the past week. Higher scores indicate greater severity of hopelessness.
  measure: Health-related quality of life
  time frame: Change in scores from baseline to 3 and 6-month post-randomization
  description: Quality of life-EuroQoL (EQ-5D) (Brooks, R. and Group, E., 1996): This is a standardised instrument to measure health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Higher scores indicate better quality of life.
  measure: Client Service Receipt Inventory
  time frame: Change in scores from baseline to 3 and 6-month post-randomization
  description: Detailed description of the use of health services will be collected using the Client Service Receipt Inventory (CSRI)
  measure: Client Satisfaction Questionnaire
  time frame: level of satisfaction at end of intervention i.e., 3-month post-randomization
  description: The Client Satisfaction Questionnaire (Attkisson, Zwick, & planning, 1982) is an 8 item measure of client satisfaction with services. Higher scores indicate greater satisfaction with the services received.
  arm group label: Intervention
  arm group type: Experimental
  description: Digitally delivered CMAP intervention through App. CMAP is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of Cognitive behavioral therapy (CBT).
  arm group label: Standard Routine Care
  arm group type: No Intervention
  description: Local medical, psychiatric and primary care services providing standard routine care to participant patients. Participants receiving an initial assessment along with TAU as ascertained by their treating doctor at the hospital or their primary care physician (general practitioner (GP)
  intervention type: Behavioral
  intervention name: CAMI
  description: Culturally Adapted manual-assisted problem solving training based Mobile Intervention (CAMI) for Suicidal Ideation. CMAP is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of Cognitive behavioral therapy (CBT). This intervention is an evaluation of suicidal ideation, crisis skills, problem-solving and CBT techniques to manage emotions, negative thinking, interpersonal relationships and relapse prevention strategies.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nasim Chaudhry, MRC Psych, FRC Psych
  role: Principal Investigator
  affiliation: Pakistan Institute of Living and Learning
  last name: Nasim Chaudhry, MRC Psych, FRC Psych, MD
  phone: 02135871845
  email: nasim.chaudhry@pill.org.pk
  last name: Tayyeba Kiran, PhD
  phone: 03328262142
  email: tayyaba.kiran@pill.org.pk
  facility: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  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