Artificial Intelligence Self Harm Application (AISHA)

March 2, 2024 updated by: Pakistan Institute of Living and Learning

Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change in scores from baseline to 3-month follow up (end of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change in scores from baseline to 3-month follow up (end of intervention)
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
Change in scores from baseline to 3-month follow up (end of intervention)
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
Change in scores from baseline to 3-month follow up (end of intervention)
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.
Level of satisfaction with the services received at end of intervention i.e., 3-month post-randomization
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).
Change in scores from baseline to 3-month follow up (end of intervention)
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.
Change in scores from baseline to 3-month follow up (end of intervention)
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
Change in scores from baseline to 3-month follow up (end of intervention)
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)
Change in scores from baseline to 3-month follow up (end of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Institute of Living and Learning

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

August 25, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 2, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PILL-AISHA-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Suicide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe