Self-harmAISHANCT06019663
Artificial Intelligence Self Harm Application
A study testing The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP in people with Self-harm and Suicide, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- What is being tested?
- The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Jun 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Civil Hospital
Karachi, Sindh, 203393
Sehrish Tofique, PhD Fellow, sehrish.tofique@pill.org.pk
Benazir Bhutto Hospital
Rawalpindi, Punjab Province, 203393
Tayyeba Kiran, PhD, tayyaba.kiran@pill.org.pk
About this study
Official 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.
Read the 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.
- Being tested
- The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP
- Keywords
- self-harm, suicide, adolescents, young people, artificial intelligence, problem-solving, CBT, Pakistan, LMIC, Digital
- Medical subject headings
- Self-Injurious Behavior, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change in scores from baseline to 3-month follow up (end of intervention)
Secondary outcomes (8)
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).
Measured: Change in scores from baseline to 3-month follow up (end of intervention)
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.
Measured: Change in scores from baseline to 3-month follow up (end of intervention)
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
Measured: Change in scores from baseline to 3-month follow up (end of intervention)
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.
Measured: Change in scores from baseline to 3-month follow up (end of intervention)
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
Measured: Change in scores from baseline to 3-month follow up (end of intervention)
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
Measured: Change in scores from baseline to 3-month follow up (end of intervention)
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.
Measured: Level of satisfaction with the services received at end of intervention i.e., 3-month post-randomization
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)
Measured: Change in scores from baseline to 3-month follow up (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Jun 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Self-harmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019663
- Sponsor's protocol ID
- PILL-AISHA-001
- Acronym
- AISHA
- Status last verified
- Mar 2024
- First submitted
- 25 Aug 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37525207Husain 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.
PubMed 35568489
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application
- ClinicalTrials.gov ID
- NCT06019663
- Acronym / sponsor ID
- AISHA / PILL-AISHA-001
- Keywords
- self-harm, suicide, adolescents, young people, artificial intelligence, problem-solving, CBT, Pakistan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAPYCMAP 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. | Behavioural | Intervention |
Primary outcome
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
8 secondary outcomes
Beck Hopelessness Scale
Time frame: 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)
Coping resource inventory
Time frame: Change in scores from baseline to 3-month follow up (end of intervention)
The Resilience Scale
Time frame: 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)
Euro-Qol Quality of Life Scale
Time frame: 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
Client Service Receipt Inventory
Time frame: Change in scores from baseline to 3-month follow up (end of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 37525207Husain 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.
- Background: PubMed 35568489Husain 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP in people with Self-harm and Suicide, run by Pakistan Institute of Living and Learning at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasim Chaudhry (02135871845, nasim.chaudhry@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Scale for Suicide Ideation (time frame: Change in scores from baseline to 3-month follow up (end of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019663, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.