Clinical trial NCT06019663: Artificial Intelligence Self Harm Application
Official title: Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Self-harm
Suicide
Keywords: self-harm
suicide
adolescents
young people
artificial intelligence
problem-solving
CBT
Pakistan
LMIC
Digital
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 312
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility 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

Primary outcomes:
measure: Beck Scale for Suicide Ideation
timeFrame: Change in scores from baseline to 3-month follow up (end of intervention)
Secondary outcomes:
measure: Beck Hopelessness Scale
timeFrame: Change in scores from baseline to 3-month follow up (end of intervention)
measure: Beck Depression Inventory
timeFrame: Change in scores from baseline to 3-month follow up (end of intervention)
measure: Coping resource inventory
timeFrame: Change in scores from baseline to 3-month follow up (end of intervention)
measure: The Resilience Scale
timeFrame: Change in scores from baseline to 3-month follow up (end of intervention)
measure: The Problem Solving Inventory
timeFrame: Change in scores from baseline to 3-month follow up (end of intervention)
measure: Euro-Qol Quality of Life Scale
timeFrame: Change in scores from baseline to 3-month follow up (end of intervention)
measure: Client Satisfaction Questionnaire
timeFrame: Level of satisfaction with the services received at end of intervention i.e., 3-month post-randomization
measure: Client Service Receipt Inventory
timeFrame: Change in scores from baseline to 3-month follow up (end of intervention)
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Benazir Bhutto Hospital
state: Punjab
city: Karachi
country: Pakistan
facility: Civil Hospital
state: Sindh
Study officials:
References:
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: 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.