Suicide Clinical Trial
— AISHAOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Civil Hospital | Karachi | Sindh |
Pakistan | Benazir Bhutto Hospital | Rawalpindi | Punjab |
Lead Sponsor | Collaborator |
---|---|
Pakistan Institute of Living and Learning |
Pakistan,
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
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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