Artificial Intelligence Self Harm Application

NCT06019663 | Not Yet Recruiting DMC

• 1 other identifier: PILL-AISHA-001
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 2

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.

Conditions

Self-harm; Suicide

Keywords

self-harm; suicide; adolescents; young people; artificial intelligence; problem-solving; CBT; Pakistan; LMIC; Digital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Beck Hopelessness Scale

  Change in scores from baseline to 3-month follow up (end of intervention)

• Beck Depression Inventory

  Change in scores from baseline to 3-month follow up (end of intervention)

• Coping resource inventory

  Change in scores from baseline to 3-month follow up (end of intervention)

• The Resilience Scale

  Change in scores from baseline to 3-month follow up (end of intervention)

• The Problem Solving Inventory

  Change in scores from baseline to 3-month follow up (end of intervention)

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP

Standard Routine Care

NO INTERVENTION

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

Interventions

The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (2)

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 203393, Pakistan

Location

Civil Hospital

Karachi, Sindh, 203393, Pakistan

Location

Related 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.

  PMID: 37525207 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Self-Injurious Behavior; Suicide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Nasim Chaudhry

CONTACT

02135871845; nasim.chaudhry@pill.org.pk

Sehrish Tofique

CONTACT

03242939563; sehrish.tofique@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: June 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Locations

PA (2)