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Artificial Intelligence Self Harm Application (AISHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06019663
Recruitment Status : Not yet recruiting
First Posted : August 31, 2023
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Self-harm Suicide Behavioral: The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application
Estimated Study Start Date : June 1, 2024
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm Suicide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Behavioral: The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP
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.
No Intervention: Standard Routine Care
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


Outcome Measures
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Primary Outcome Measures :
  1. Beck Scale for Suicide Ideation [ Time Frame: Change in scores from baseline to 3-month follow up (end of intervention) ]
    This is a self-report measure of current suicidal ideation. 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. 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


Secondary Outcome Measures :
  1. Beck Hopelessness Scale [ Time Frame: Change in scores from baseline to 3-month follow up (end of intervention) ]
    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).

  2. Beck Depression Inventory [ Time Frame: Change in scores from baseline to 3-month follow up (end of intervention) ]
    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.

  3. Coping resource inventory [ Time Frame: Change in scores from baseline to 3-month follow up (end of intervention) ]
    The CRI is a structured instrument to assess the coping resources to manage stress available to an individual. Higher scores indicate better coping skills

  4. The Resilience Scale [ Time Frame: Change in scores from baseline to 3-month follow up (end of intervention) ]
    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.

  5. The Problem Solving Inventory [ Time Frame: Change in scores from baseline to 3-month follow up (end of intervention) ]
    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

  6. Euro-Qol Quality of Life Scale [ Time Frame: Change in scores from baseline to 3-month follow up (end of intervention) ]
    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

  7. Client Satisfaction Questionnaire [ Time Frame: Level of satisfaction with the services received at end of intervention i.e., 3-month post-randomization ]
    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.

  8. Client Service Receipt Inventory [ Time Frame: Change in scores from baseline to 3-month follow up (end of intervention) ]
    This instrument is used to collect information on the use of health services (both formal and informal sector such as physician, faith healers/Imams)


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients presented to the participating family physicians, community health centres, emergency departments or admitted to a general hospital after an episode of self-harm at participating sites.
  • Age 16 to 25 years
  • Participants must be familiar with functioning of handheld mobile devices (mobile phones, tablets).
  • Able to read Urdu or English language.
  • Individuals able to provide written informed consent.
  • Have an android mobile phone/device

Exclusion Criteria:

  • Participants with ICD-I0 mental disorder; due to a general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability which prevents participation.
  • Participants needing inpatient psychiatric treatment as determined by their clinical teams
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06019663


Contacts
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Contact: Nasim Chaudhry 02135871845 nasim.chaudhry@pill.org.pk
Contact: Sehrish Tofique 03242939563 sehrish.tofique@pill.org.pk

Locations
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Pakistan
Benazir Bhutto Hospital
Rawalpindi, Punjab, Pakistan, 203393
Contact: Tayyeba Kiran, PhD       tayyaba.kiran@pill.org.pk   
Civil Hospital
Karachi, Sindh, Pakistan, 203393
Contact: Sehrish Tofique, PhD Fellow       sehrish.tofique@pill.org.pk   
Sponsors and Collaborators
Pakistan Institute of Living and Learning
More Information
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Publications:

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Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT06019663    
Other Study ID Numbers: PILL-AISHA-001
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: March 5, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pakistan Institute of Living and Learning:
self-harm
suicide
adolescents
young people
artificial intelligence
 problem-solving
CBT
Pakistan
LMIC
Digital
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms