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Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application (AISHA)

Primary Purpose

Self-harm, Suicide

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Self-harm focused on measuring self-harm, suicide, adolescents, young people, artificial intelligence, problem-solving, CBT, Pakistan, LMIC, Digital

Eligibility Criteria

16 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Benazir Bhutto Hospital
  • Civil Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard Routine Care

Arm Description

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

Outcomes

Primary Outcome Measures

Beck Scale for Suicide Ideation
This is a self-report measure of current suicidal ideation. The 19-item instrument indicates the severity of suicidal ideation in the previous week. 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= 0.41(de Beurs, Fokkema, & O'Connor, 2016). 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

Secondary Outcome Measures

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). The test-retest scores of the scale are found to be good (r=0.81) (Ayub, 2009). The Urdu version of the BHS has been used in Pakistan and reported to have a reliability coefficient (Kuder-Richardson Index) of 0.93 (M. O. Husain et al., 2019).
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. The BDI has concurrent validity, correlating highly with the Hamilton Rating Scale for Depression (r=0.72 - 0.73) (A. T. Beck, Steer, R.A., Carbin, M.G., 1988). The test-retest reliability is also high (r= 0.60) (Jo, Park, Jo, Ryu, & Han, 2007). The Cronbach's Alpha coefficients of the Urdu translated BDI are good (0.75-0.92) (Khan, Marwat, Noor, & Fatima, 2015). We have used the Urdu translated version of this instrument in our previous work, the Cronbach's alpha was 0.97 (M. O. Husain et al., 2019).
Coping resource inventory
The CRI is a structured instrument to assess the coping resources to manage stress available to an individual. We have used Urdu translated version in our previous exploratory trial (N. Husain et al., 2014). Higher scores indicate better coping skills
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.
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
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
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.
Client Service Receipt Inventory (Beecham & Knapp, 2001):
This instrument is used to collect information on the use of health services (both formal and informal sector such as physician, faith healers/Imams)

Full Information

First Posted
August 25, 2023
Last Updated
August 25, 2023
Sponsor
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT06019663
Brief Title
Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application
Acronym
AISHA
Official Title
Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-harm, Suicide
Keywords
self-harm, suicide, adolescents, young people, artificial intelligence, problem-solving, CBT, Pakistan, LMIC, Digital

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
312 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Standard Routine Care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
The Artificial Intelligence intervention for Self-Harm prevention Application (AISHA) is a mobile intervention based on Y-CMAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Beck Scale for Suicide Ideation
Description
This is a self-report measure of current suicidal ideation. The 19-item instrument indicates the severity of suicidal ideation in the previous week. 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= 0.41(de Beurs, Fokkema, & O'Connor, 2016). 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
Time Frame
Change in scores from baseline to 3-month follow up (end of intervention)
Secondary Outcome Measure Information:
Title
Beck Hopelessness Scale
Description
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). The test-retest scores of the scale are found to be good (r=0.81) (Ayub, 2009). The Urdu version of the BHS has been used in Pakistan and reported to have a reliability coefficient (Kuder-Richardson Index) of 0.93 (M. O. Husain et al., 2019).
Time Frame
Change in scores from baseline to 3-month follow up (end of intervention)
Title
Beck Depression Inventory
Description
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. The BDI has concurrent validity, correlating highly with the Hamilton Rating Scale for Depression (r=0.72 - 0.73) (A. T. Beck, Steer, R.A., Carbin, M.G., 1988). The test-retest reliability is also high (r= 0.60) (Jo, Park, Jo, Ryu, & Han, 2007). The Cronbach's Alpha coefficients of the Urdu translated BDI are good (0.75-0.92) (Khan, Marwat, Noor, & Fatima, 2015). We have used the Urdu translated version of this instrument in our previous work, the Cronbach's alpha was 0.97 (M. O. Husain et al., 2019).
Time Frame
Change in scores from baseline to 3-month follow up (end of intervention)
Title
Coping resource inventory
Description
The CRI is a structured instrument to assess the coping resources to manage stress available to an individual. We have used Urdu translated version in our previous exploratory trial (N. Husain et al., 2014). Higher scores indicate better coping skills
Time Frame
Change in scores from baseline to 3-month follow up (end of intervention)
Title
The Resilience Scale
Description
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.
Time Frame
Change in scores from baseline to 3-month follow up (end of intervention)
Title
The Problem Solving Inventory
Description
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
Time Frame
Change in scores from baseline to 3-month follow up (end of intervention)
Title
Euro-Qol Quality of Life Scale
Description
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
Time Frame
Change in scores from baseline to 3-month follow up (end of intervention)
Title
Client Satisfaction Questionnaire
Description
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.
Time Frame
Level of satisfaction with the services received at end of intervention i.e., 3-month post-randomization
Title
Client Service Receipt Inventory (Beecham & Knapp, 2001):
Description
This instrument is used to collect information on the use of health services (both formal and informal sector such as physician, faith healers/Imams)
Time Frame
Change in scores from baseline to 3-month follow up (end of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasim Chaudhry
Phone
02135871845
Email
nasim.chaudhry@pill.org.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Sehrish Tofique
Phone
03242939563
Email
sehrish.tofique@pill.org.pk
Facility Information:
Facility Name
Benazir Bhutto Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
203393
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tayyeba Kiran, PhD
Email
tayyaba.kiran@pill.org.pk
Facility Name
Civil Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
203393
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sehrish Tofique, PhD Fellow
Email
sehrish.tofique@pill.org.pk

12. IPD Sharing Statement

Citations:
PubMed Identifier
37525207
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.
Results Reference
background
PubMed Identifier
35568489
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.
Results Reference
background

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Exploratory Randomised Controlled Trial of an Artificial Intelligence Self Harm Application

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