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Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06019689
Acronym
CAMI
Enrollment
80
Registered
2023-08-31
Start date
2024-05-01
Completion date
2025-06-30
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicidal Ideation

Keywords

self-harm, suicidal ideation, Mobile intervention, cultural adaptation, Pakistan, LMIC, Problem-solving, CBT

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.

Interventions

BEHAVIORALCAMI

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.

Sponsors

Pakistan Institute of Living and Learning
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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.

Intervention model description

multicenter exploratory RCT

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Suicide Ideation .Change in scores from baseline to 3 and 6-month post-randomizationThe 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

MeasureTime frameDescription
DepressionChange in scores from baseline to 3 and 6-month post-randomizationBeck Depression Inventory (BDI), which is a 21-item scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
HopelessnessChange in scores from baseline to 3 and 6-month post-randomizationBeck 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 lifeChange in scores from baseline to 3 and 6-month post-randomizationQuality 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 InventoryChange in scores from baseline to 3 and 6-month post-randomizationDetailed description of the use of health services will be collected using the Client Service Receipt Inventory (CSRI)
Client Satisfaction Questionnairelevel of satisfaction at end of intervention i.e., 3-month post-randomizationThe 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.

Countries

Pakistan

Contacts

Primary ContactNasim Chaudhry, MRC Psych, FRC Psych, MD
nasim.chaudhry@pill.org.pk02135871845
Backup ContactTayyeba Kiran, PhD
tayyaba.kiran@pill.org.pk03328262142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026