Artificial Intelligence Self Harm Application

Suicide Clinical Trial

— AISHA  

Official title:

Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06019663
• Other study ID #: PILL-AISHA-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Pakistan Institute of Living and Learning
• Contact: Nasim Chaudhry
• Phone: 02135871845
• Email: nasim.chaudhry[@]pill.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 312
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Self-harm
• Self-Injurious Behavior
• Suicide

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.

Locations

Country	Name	City	State
Pakistan	Civil Hospital	Karachi	Sindh
Pakistan	Benazir Bhutto Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Scale for Suicide Ideation	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	Change in scores from baseline to 3-month follow up (end of intervention)
Secondary	Beck Hopelessness Scale	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).	Change in scores from baseline to 3-month follow up (end of intervention)
Secondary	Beck Depression Inventory	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.	Change in scores from baseline to 3-month follow up (end of intervention)
Secondary	Coping resource inventory	The CRI is a structured instrument to assess the coping resources to manage stress available to an individual. Higher scores indicate better coping skills	Change in scores from baseline to 3-month follow up (end of intervention)
Secondary	The Resilience Scale	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.	Change in scores from baseline to 3-month follow up (end of intervention)
Secondary	The Problem Solving Inventory	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	Change in scores from baseline to 3-month follow up (end of intervention)
Secondary	Euro-Qol Quality of Life Scale	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	Change in scores from baseline to 3-month follow up (end of intervention)
Secondary	Client Satisfaction Questionnaire	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.	Level of satisfaction with the services received at end of intervention i.e., 3-month post-randomization
Secondary	Client Service Receipt Inventory	This instrument is used to collect information on the use of health services (both formal and informal sector such as physician, faith healers/Imams)	Change in scores from baseline to 3-month follow up (end of intervention)