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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06019663
Other study ID # PILL-AISHA-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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