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ClinicalTrials.gov ID

NCT06019689

Lead Sponsor

Pakistan Institute of Living and LearningOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

80Estimated

Last Update Posted

Mar 5, 2024Actual

Start Date

May 1, 2024Estimated

Primary Completion Date

Dec 30, 2024Estimated

Completion Date

Jun 30, 2025Estimated

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

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.

• Suicidal Ideation

• CAMI

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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.

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Pakistan Institute of Living and LearningOTHER

03242939563