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/NCT06019663</url>
    </required_header>
    <id_info>
      <org_study_id>PILL-AISHA-001</org_study_id>
      <nct_id>NCT06019663</nct_id>
    </id_info>
    <brief_title>Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application</brief_title>
    <acronym>AISHA</acronym>
    <official_title>Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application</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>
        This is a mixed-methods study. The quantitative component will comprise of a multicentre&#xD;
        rater-blind, randomized controlled trial to evaluate the feasibility and acceptability of&#xD;
        AISHA in addition to treatment as usual (TAU) compared to TAU alone in Pakistan.&#xD;
  &#xD;
        In-depth interviews and focus groups with other stakeholders will take place to consider the&#xD;
        wider implementation of AISHA in mental health services in Pakistan.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mental health resources in LMICs, including Pakistan, do not match the burden of mental&#xD;
        illness, resulting in a massive mental health treatment gap. Interventions delivered on&#xD;
        mobile platforms (M-Health) have the potential to overcome these barriers. Evidence supports&#xD;
        the acceptability and efficacy of interventions delivered on digital platforms for a variety&#xD;
        of mental disorders. Mobile-based interventions have been developed to target self-harm,&#xD;
        however, there is paucity of research supporting their efficacy in LMIC.&#xD;
  &#xD;
        To our knowledge there are currently no clinical trials examining the feasibility,&#xD;
        acceptability and preliminary efficacy of a culturally adapted CBT informed problem solving&#xD;
        intervention delivered on a digital platform for self-harm prevention.We have developed an&#xD;
        Artificial Intelligence Self-Harm prevention Application (AISHA) to deliver an evidence-based&#xD;
        problem solving intervention (CMAP) for people presenting with self-harm.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 30, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 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>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Beck Scale for Suicide Ideation</measure>
      <time_frame>Change in scores from baseline to 3-month follow up (end of intervention)</time_frame>
      <description>This is a self-report measure of current suicidal ideation. The 19-item instrument indicates the severity of suicidal ideation in the previous week. Higher scores (≥6) on the scale indicate greater risk. When measured against other instruments of suicidal ideation, the convergent validity of the BSI has been demonstrated, r= 0.41(de Beurs, Fokkema, &amp; O'Connor, 2016). We have used the Urdu translated version of this instrument in prior work from Pakistan and found the Cronbach's alpha to be 0.89 (M. O. Husain et al., 2019). Higher scores indicate greater severity of suicidal ideation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Beck Hopelessness Scale</measure>
      <time_frame>Change in scores from baseline to 3-month follow up (end of intervention)</time_frame>
      <description>This is a 20-item self-report instrument designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations. Higher scores indicate increasing severity of hopelessness; normal (0-3), mild hopelessness (4-8), moderate hopelessness (9-14), severe hopelessness (&gt;14). The test-retest scores of the scale are found to be good (r=0.81) (Ayub, 2009). The Urdu version of the BHS has been used in Pakistan and reported to have a reliability coefficient (Kuder-Richardson Index) of 0.93 (M. O. Husain et al., 2019).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Beck Depression Inventory</measure>
      <time_frame>Change in scores from baseline to 3-month follow up (end of intervention)</time_frame>
      <description>This is a 21-item scale of depressive symptoms. Higher scores on the scale indicate greater severity of depression. Mild depression is indicated by scores of 14 -19; Moderate depression scores of 20 - 28 and Severe depression scores of 29-63. The BDI has concurrent validity, correlating highly with the Hamilton Rating Scale for Depression (r=0.72 - 0.73) (A. T. Beck, Steer, R.A., Carbin, M.G., 1988). The test-retest reliability is also high (r= 0.60) (Jo, Park, Jo, Ryu, &amp; Han, 2007). The Cronbach's Alpha coefficients of the Urdu translated BDI are good (0.75-0.92) (Khan, Marwat, Noor, &amp; Fatima, 2015). We have used the Urdu translated version of this instrument in our previous work, the Cronbach's alpha was 0.97 (M. O. Husain et al., 2019).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coping resource inventory</measure>
      <time_frame>Change in scores from baseline to 3-month follow up (end of intervention)</time_frame>
      <description>The CRI is a structured instrument to assess the coping resources to manage stress available to an individual. We have used Urdu translated version in our previous exploratory trial (N. Husain et al., 2014). Higher scores indicate better coping skills</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Resilience Scale</measure>
      <time_frame>Change in scores from baseline to 3-month follow up (end of intervention)</time_frame>
      <description>The RS is a 25-item self-report scale that aims to assess an individual's level of resilience. This is a 7 point Likert Scale and provides a total score of resilience, ranging from 25 to 175, with higher scores indicative of higher levels of resilience.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Problem Solving Inventory</measure>
      <time_frame>Change in scores from baseline to 3-month follow up (end of intervention)</time_frame>
      <description>The PSI is a 35-item instrument that measures the individual's perceptions regarding one's problem-solving style and problem-solving abilities in the everyday life. It consists of three subscales. Higher scores indicate higher level of problem solving abilities</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Euro-Qol Quality of Life Scale</measure>
      <time_frame>Change in scores from baseline to 3-month follow up (end of intervention)</time_frame>
      <description>This is an instrument which is used to measure quality of life or health profiles of participants. Higher scores indicate higher health related quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Client Satisfaction Questionnaire</measure>
      <time_frame>Level of satisfaction with the services received at end of intervention i.e., 3-month post-randomization</time_frame>
      <description>This is an eight item self-report questionnaire used to assess participant's satisfaction with the services using a 4-point likert scale. Higher scores indicate greater satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Client Service Receipt Inventory (Beecham &amp; Knapp, 2001):</measure>
      <time_frame>Change in scores from baseline to 3-month follow up (end of intervention)</time_frame>
      <description>This instrument is used to collect information on the use of health services (both formal and informal sector such as physician, faith healers/Imams)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">312</enrollment>
    <condition>Self-harm</condition>
    <condition>Suicide</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Routine Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard care for self-ham in Pakistan does not usually involve psychiatric or psychotherapy follow-up. Clinical teams in psychiatric departments or family medicine practices provide standard routine care according to their clinical judgment and available resources. We will obtain details of any treatment received by each participant</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP</intervention_name>
      <description>YCMAP is a &quot;Youth culturally adapted manual assisted psychological intervention&quot; based on CBT principles. The therapy focuses on current problems that contributed to the self-harm episode. Therapists and adolescent clients choose from a list of techniques those which are most relevant to the client's problems. Therapy is therefore adapted to fit with the client's problems and primarily utilises problem solving, CBT, and dialectical therapy strategies to bring about change.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients presented to the participating family physicians, community health&#xD;
               centres, emergency departments or admitted to a general hospital after an episode of&#xD;
               self-harm at participating sites.&#xD;
  &#xD;
            -  Age 16 to 25 years&#xD;
  &#xD;
            -  Participants must be familiar with functioning of handheld mobile devices (mobile&#xD;
               phones, tablets).&#xD;
  &#xD;
            -  Able to read Urdu or English language.&#xD;
  &#xD;
            -  Individuals able to provide written informed consent.&#xD;
  &#xD;
            -  Have an android mobile phone/device&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants with ICD-I0 mental disorder; due to a general medical condition or&#xD;
               substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia,&#xD;
               bipolar disorder, learning disability which prevents participation.&#xD;
  &#xD;
            -  Participants needing inpatient psychiatric treatment as determined by their clinical&#xD;
               teams&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nasim Chaudhry</last_name>
      <phone>02135871845</phone>
      <email>nasim.chaudhry@pill.org.pk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sehrish Tofique</last_name>
      <phone>03242939563</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>
      <facility>
        <name>Civil Hospital</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <zip>203393</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <contact>
        <last_name>Sehrish Tofique, PhD Fellow</last_name>
        <email>sehrish.tofique@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>
    <reference>
      <citation>Husain N, Tofique S, Chaudhry IB, Kiran T, Taylor P, Williams C, Memon R, Aggarwal S, Alvi MH, Ananiadou S, Ansari MA, Aseem S, Beck A, Alam S, Colucci E, Davidson K, Edwards S, Emsley R, Green J, Gumber A, Hawton K, Jafri F, Khaliq A, Mason T, Mcreath A, Minhas A, Naeem F, Naqvi HA, Noureen A, Panagioti M, Patel A, Poppleton A, Shiri T, Simic M, Sultan S, Nizami AT, Zadeh Z, Zafar SN, Chaudhry N. Youth Culturally adapted Manual Assisted Problem Solving Training (YCMAP) in Pakistani adolescent with a history of self-harm: protocol for multicentre clinical and cost-effectiveness randomised controlled trial. BMJ Open. 2022 May 13;12(5):e056301. doi: 10.1136/bmjopen-2021-056301.</citation>
      <PMID>35568489</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>self-harm</keyword>
    <keyword>suicide</keyword>
    <keyword>adolescents</keyword>
    <keyword>young people</keyword>
    <keyword>artificial intelligence</keyword>
    <keyword>problem-solving</keyword>
    <keyword>CBT</keyword>
    <keyword>Pakistan</keyword>
    <keyword>LMIC</keyword>
    <keyword>Digital</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Suicide</mesh_term>
      <mesh_term>Self-Injurious Behavior</mesh_term>
    </condition_browse>
    <!-- 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/NCT06019663
  org study id: PILL-AISHA-001
  nct id: NCT06019663
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a mixed-methods study. The quantitative component will comprise of a multicentre
        rater-blind, randomized controlled trial to evaluate the feasibility and acceptability of
        AISHA in addition to treatment as usual (TAU) compared to TAU alone in Pakistan.
  
        In-depth interviews and focus groups with other stakeholders will take place to consider the
        wider implementation of AISHA in mental health services in Pakistan.
  Mental health resources in LMICs, including Pakistan, do not match the burden of mental
        illness, resulting in a massive mental health treatment gap. Interventions delivered on
        mobile platforms (M-Health) have the potential to overcome these barriers. Evidence supports
        the acceptability and efficacy of interventions delivered on digital platforms for a variety
        of mental disorders. Mobile-based interventions have been developed to target self-harm,
        however, there is paucity of research supporting their efficacy in LMIC.
  
        To our knowledge there are currently no clinical trials examining the feasibility,
        acceptability and preliminary efficacy of a culturally adapted CBT informed problem solving
        intervention delivered on a digital platform for self-harm prevention.We have developed an
        Artificial Intelligence Self-Harm prevention Application (AISHA) to deliver an evidence-based
        problem solving intervention (CMAP) for people presenting with self-harm.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: Beck Scale for Suicide Ideation
  time frame: Change in scores from baseline to 3-month follow up (end of intervention)
  description: This is a self-report measure of current suicidal ideation. The 19-item instrument indicates the severity of suicidal ideation in the previous week. Higher scores (≥6) on the scale indicate greater risk. When measured against other instruments of suicidal ideation, the convergent validity of the BSI has been demonstrated, r= 0.41(de Beurs, Fokkema, & O'Connor, 2016). We have used the Urdu translated version of this instrument in prior work from Pakistan and found the Cronbach's alpha to be 0.89 (M. O. Husain et al., 2019). Higher scores indicate greater severity of suicidal ideation
  measure: Beck Hopelessness Scale
  time frame: Change in scores from baseline to 3-month follow up (end of intervention)
  description: This is a 20-item self-report instrument designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations. Higher scores indicate increasing severity of hopelessness; normal (0-3), mild hopelessness (4-8), moderate hopelessness (9-14), severe hopelessness (>14). The test-retest scores of the scale are found to be good (r=0.81) (Ayub, 2009). The Urdu version of the BHS has been used in Pakistan and reported to have a reliability coefficient (Kuder-Richardson Index) of 0.93 (M. O. Husain et al., 2019).
  measure: Beck Depression Inventory
  time frame: Change in scores from baseline to 3-month follow up (end of intervention)
  description: This is a 21-item scale of depressive symptoms. Higher scores on the scale indicate greater severity of depression. Mild depression is indicated by scores of 14 -19; Moderate depression scores of 20 - 28 and Severe depression scores of 29-63. The BDI has concurrent validity, correlating highly with the Hamilton Rating Scale for Depression (r=0.72 - 0.73) (A. T. Beck, Steer, R.A., Carbin, M.G., 1988). The test-retest reliability is also high (r= 0.60) (Jo, Park, Jo, Ryu, & Han, 2007). The Cronbach's Alpha coefficients of the Urdu translated BDI are good (0.75-0.92) (Khan, Marwat, Noor, & Fatima, 2015). We have used the Urdu translated version of this instrument in our previous work, the Cronbach's alpha was 0.97 (M. O. Husain et al., 2019).
  measure: Coping resource inventory
  time frame: Change in scores from baseline to 3-month follow up (end of intervention)
  description: The CRI is a structured instrument to assess the coping resources to manage stress available to an individual. We have used Urdu translated version in our previous exploratory trial (N. Husain et al., 2014). Higher scores indicate better coping skills
  measure: The Resilience Scale
  time frame: Change in scores from baseline to 3-month follow up (end of intervention)
  description: The RS is a 25-item self-report scale that aims to assess an individual's level of resilience. This is a 7 point Likert Scale and provides a total score of resilience, ranging from 25 to 175, with higher scores indicative of higher levels of resilience.
  measure: The Problem Solving Inventory
  time frame: Change in scores from baseline to 3-month follow up (end of intervention)
  description: The PSI is a 35-item instrument that measures the individual's perceptions regarding one's problem-solving style and problem-solving abilities in the everyday life. It consists of three subscales. Higher scores indicate higher level of problem solving abilities
  measure: Euro-Qol Quality of Life Scale
  time frame: Change in scores from baseline to 3-month follow up (end of intervention)
  description: This is an instrument which is used to measure quality of life or health profiles of participants. Higher scores indicate higher health related quality of life
  measure: Client Satisfaction Questionnaire
  time frame: Level of satisfaction with the services received at end of intervention i.e., 3-month post-randomization
  description: This is an eight item self-report questionnaire used to assess participant's satisfaction with the services using a 4-point likert scale. Higher scores indicate greater satisfaction.
  measure: Client Service Receipt Inventory (Beecham & Knapp, 2001):
  time frame: Change in scores from baseline to 3-month follow up (end of intervention)
  description: This instrument is used to collect information on the use of health services (both formal and informal sector such as physician, faith healers/Imams)
  arm group label: Intervention
  arm group type: Experimental
  arm group label: Standard Routine Care
  arm group type: No Intervention
  description: Standard care for self-ham in Pakistan does not usually involve psychiatric or psychotherapy follow-up. Clinical teams in psychiatric departments or family medicine practices provide standard routine care according to their clinical judgment and available resources. We will obtain details of any treatment received by each participant
  intervention type: Behavioral
  intervention name: The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP
  description: YCMAP is a "Youth culturally adapted manual assisted psychological intervention" based on CBT principles. The therapy focuses on current problems that contributed to the self-harm episode. Therapists and adolescent clients choose from a list of techniques those which are most relevant to the client's problems. Therapy is therefore adapted to fit with the client's problems and primarily utilises problem solving, CBT, and dialectical therapy strategies to bring about change.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: Nasim Chaudhry
  phone: 02135871845
  email: nasim.chaudhry@pill.org.pk
  last name: Sehrish Tofique
  phone: 03242939563
  email: sehrish.tofique@pill.org.pk
  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
  citation: Husain N, Tofique S, Chaudhry IB, Kiran T, Taylor P, Williams C, Memon R, Aggarwal S, Alvi MH, Ananiadou S, Ansari MA, Aseem S, Beck A, Alam S, Colucci E, Davidson K, Edwards S, Emsley R, Green J, Gumber A, Hawton K, Jafri F, Khaliq A, Mason T, Mcreath A, Minhas A, Naeem F, Naqvi HA, Noureen A, Panagioti M, Patel A, Poppleton A, Shiri T, Simic M, Sultan S, Nizami AT, Zadeh Z, Zafar SN, Chaudhry N. Youth Culturally adapted Manual Assisted Problem Solving Training (YCMAP) in Pakistani adolescent with a history of self-harm: protocol for multicentre clinical and cost-effectiveness randomised controlled trial. BMJ Open. 2022 May 13;12(5):e056301. doi: 10.1136/bmjopen-2021-056301.
  PMID: 35568489
  responsible party type: Sponsor
  mesh term: Suicide
  mesh term: Self-Injurious Behavior