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Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention (CAMI)

Primary Purpose

Suicidal Ideation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
CAMI
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring self-harm, suicidal ideation, Mobile intervention, cultural adaptation, Pakistan, LMIC, Problem-solving, CBT

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals (aged 18-64) screened and identified as having suicidal ideation Able to give written informed consent Living within the catchment areas of participating hospitals Have a smart phone and able to operate it Able to read and speak Urdu Not requiring in-patient psychiatric treatment. Exclusion Criteria: Presence of a diagnosed physical or intellectual disability as it can prevent individuals from engaging with the intervention. This will be assessed by the research team at screening stage. Any disabilities will be identified by a relevant clinician (e.g. Psychiatrist). Temporary resident unlikely to be available for follow-up (b) participants with a diagnosis of DSM-IV mental disorder due to general medical condition or substance misuse, dementia, delirium, alcohol and drug dependence, schizophrenia, or bipolar disorder.

Sites / Locations

  • Quetta Site
  • Peshawar Site
  • Lahore Site
  • Multan Site
  • Rawalpindi Site
  • Hyderabad Site
  • Karachi Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard Routine Care

Arm Description

Digitally delivered CMAP intervention through App. CMAP is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of Cognitive behavioral therapy (CBT).

Local medical, psychiatric and primary care services providing standard routine care to participant patients. Participants receiving an initial assessment along with TAU as ascertained by their treating doctor at the hospital or their primary care physician (general practitioner (GP)

Outcomes

Primary Outcome Measures

Suicide Ideation .
The BSI is a 19-item self-report instrument for detecting and measuring the current intensity of the patient's attitudes, behaviors and specificity of a patient's thoughts to die by suicide during the past week. Higher scores indicate greater severity of suicidal ideation

Secondary Outcome Measures

Depression
Beck Depression Inventory (BDI), which is a 21-item scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
Hopelessness
Beck Hopelessness Scale (BHS) (Beck, A and Steer, R, 1988) is a self-report instrument designed to measure three aspects of hopelessness: feelings about the future, loss of motivation and expectations during the past week. Higher scores indicate greater severity of hopelessness.
Health-related quality of life
Quality of life-EuroQoL (EQ-5D) (Brooks, R. and Group, E., 1996): This is a standardised instrument to measure health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Higher scores indicate better quality of life.
Client Service Receipt Inventory
Detailed description of the use of health services will be collected using the Client Service Receipt Inventory (CSRI)
Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire (Attkisson, Zwick, & planning, 1982) is an 8 item measure of client satisfaction with services. Higher scores indicate greater satisfaction with the services received.

Full Information

First Posted
August 25, 2023
Last Updated
August 30, 2023
Sponsor
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT06019689
Brief Title
Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention
Acronym
CAMI
Official Title
Exploratory Study of a Culturally Adapted Manual-assisted Problem-solving Mobile Based Intervention (CAMI) for Suicidal Ideation: A Multicentre, Two Arm, Randomized Controlled Trial From Pakistan
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 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
Determine the feasibility, acceptability and efficacy of an adapted digitally delivered CMAP (CMAP-SI) intervention (CAMI) compared to treatment as usual (TAU) for patients presenting with suicidal ideation.
Detailed Description
The reported suicide rates in South Asia are high compared to the global average. These figures are likely to be an underestimate since suicide data from many LMICs such as Pakistan is lacking and what is available is not reliable (Jordans et al., 2014). According to an estimate, 5,000 to 7,000 suicides take place each year in Pakistan (Hafeez, 2016) and at least 10 to 20 suicide attempts happen for every suicide. Mobile health is a novel and emerging field in psychiatric and psychological care and treatment of mental health difficulties, it involves the use of telecommunications to provide health care, support and intervention from a distance. The proposed study will be carried out in two phases; Stage 1) adaptation of an already existing culturally adapted manual assisted problem solving intervention (CMAP) for patients with suicidal ideation presenting to primary care in Pakistan and further adaptation into a digital intervention. Stage 2) feasibility Randomised Control trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
self-harm, suicidal ideation, Mobile intervention, cultural adaptation, Pakistan, LMIC, Problem-solving, CBT

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
multicenter exploratory RCT
Masking
Outcomes Assessor
Masking Description
Researcher conducting assessments will be masked to participant group allocation. This will be achieved by briefing participants and research staff in advance around maintaining masking.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Digitally delivered CMAP intervention through App. CMAP is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of Cognitive behavioral therapy (CBT).
Arm Title
Standard Routine Care
Arm Type
No Intervention
Arm Description
Local medical, psychiatric and primary care services providing standard routine care to participant patients. Participants receiving an initial assessment along with TAU as ascertained by their treating doctor at the hospital or their primary care physician (general practitioner (GP)
Intervention Type
Behavioral
Intervention Name(s)
CAMI
Intervention Description
Culturally Adapted manual-assisted problem solving training based Mobile Intervention (CAMI) for Suicidal Ideation. CMAP is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of Cognitive behavioral therapy (CBT). This intervention is an evaluation of suicidal ideation, crisis skills, problem-solving and CBT techniques to manage emotions, negative thinking, interpersonal relationships and relapse prevention strategies.
Primary Outcome Measure Information:
Title
Suicide Ideation .
Description
The BSI is a 19-item self-report instrument for detecting and measuring the current intensity of the patient's attitudes, behaviors and specificity of a patient's thoughts to die by suicide during the past week. Higher scores indicate greater severity of suicidal ideation
Time Frame
Change in scores from baseline to 3 and 6-month post-randomization
Secondary Outcome Measure Information:
Title
Depression
Description
Beck Depression Inventory (BDI), which is a 21-item scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
Time Frame
Change in scores from baseline to 3 and 6-month post-randomization
Title
Hopelessness
Description
Beck Hopelessness Scale (BHS) (Beck, A and Steer, R, 1988) is a self-report instrument designed to measure three aspects of hopelessness: feelings about the future, loss of motivation and expectations during the past week. Higher scores indicate greater severity of hopelessness.
Time Frame
Change in scores from baseline to 3 and 6-month post-randomization
Title
Health-related quality of life
Description
Quality of life-EuroQoL (EQ-5D) (Brooks, R. and Group, E., 1996): This is a standardised instrument to measure health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Higher scores indicate better quality of life.
Time Frame
Change in scores from baseline to 3 and 6-month post-randomization
Title
Client Service Receipt Inventory
Description
Detailed description of the use of health services will be collected using the Client Service Receipt Inventory (CSRI)
Time Frame
Change in scores from baseline to 3 and 6-month post-randomization
Title
Client Satisfaction Questionnaire
Description
The Client Satisfaction Questionnaire (Attkisson, Zwick, & planning, 1982) is an 8 item measure of client satisfaction with services. Higher scores indicate greater satisfaction with the services received.
Time Frame
level of satisfaction at end of intervention i.e., 3-month post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals (aged 18-64) screened and identified as having suicidal ideation Able to give written informed consent Living within the catchment areas of participating hospitals Have a smart phone and able to operate it Able to read and speak Urdu Not requiring in-patient psychiatric treatment. Exclusion Criteria: Presence of a diagnosed physical or intellectual disability as it can prevent individuals from engaging with the intervention. This will be assessed by the research team at screening stage. Any disabilities will be identified by a relevant clinician (e.g. Psychiatrist). Temporary resident unlikely to be available for follow-up (b) participants with a diagnosis of DSM-IV mental disorder due to general medical condition or substance misuse, dementia, delirium, alcohol and drug dependence, schizophrenia, or bipolar disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nasim Chaudhry, MRC Psych, FRC Psych, MD
Phone
02135871845
Email
nasim.chaudhry@pill.org.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Tayyeba Kiran, PhD
Phone
03328262142
Email
tayyaba.kiran@pill.org.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasim Chaudhry, MRC Psych, FRC Psych
Organizational Affiliation
Pakistan Institute of Living and Learning
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quetta Site
City
Quetta
State/Province
Balochistan
Country
Pakistan
Facility Name
Peshawar Site
City
Peshawar
State/Province
KPK
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
umair
Facility Name
Lahore Site
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayesha Khaliq, MS
Facility Name
Multan Site
City
Multan
State/Province
Punjab
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zehra Nigah, Mphil
Facility Name
Rawalpindi Site
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samia Shahid, BS
Facility Name
Hyderabad Site
City
Hyderabad
State/Province
Sindh
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faster Gill
Facility Name
Karachi Site
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75350
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sehrish Tofique
Phone
03242939563

12. IPD Sharing Statement

Plan to Share IPD
No
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

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Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention

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