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

Sponsor

Pakistan Institute of Living and Learning (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06019689

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

11.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Suicidal Ideation	Behavioral: CAMI	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

multicenter exploratory RCTmulticenter exploratory RCT

Masking:

Single (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.

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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).	Behavioral: CAMI 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.
No Intervention: Standard Routine Care 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)

Arm

Intervention/Treatment

Experimental: Intervention

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).

Behavioral: CAMI

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.

No Intervention: Standard Routine Care

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)

Outcome Measures

Primary Outcome Measures

Suicide Ideation . [Change in scores from baseline to 3 and 6-month post-randomization]
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 [Change in scores from baseline to 3 and 6-month post-randomization]
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 [Change in scores from baseline to 3 and 6-month post-randomization]
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 [Change in scores from baseline to 3 and 6-month post-randomization]
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 [Change in scores from baseline to 3 and 6-month post-randomization]
Detailed description of the use of health services will be collected using the Client Service Receipt Inventory (CSRI)
Client Satisfaction Questionnaire [level of satisfaction at end of intervention i.e., 3-month post-randomization]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quetta Site	Quetta	Balochistan	Pakistan
2	Peshawar Site	Peshawar	KPK	Pakistan
3	Lahore Site	Lahore	Punjab	Pakistan
4	Multan Site	Multan	Punjab	Pakistan
5	Rawalpindi Site	Rawalpindi	Punjab	Pakistan
6	Hyderabad Site	Hyderabad	Sindh	Pakistan
7	Karachi Site	Karachi	Sindh	Pakistan	75350