Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention

Suicidal Ideation Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06019689
• Other study ID #: PILL-CAMI
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Pakistan Institute of Living and Learning
• Contact: Nasim Chaudhry, MRC Psych, FRC Psych, MD
• Phone: 02135871845
• Email: nasim.chaudhry[@]pill.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Hyderabad Site	Hyderabad	Sindh
Pakistan	Karachi Site	Karachi	Sindh
Pakistan	Lahore Site	Lahore	Punjab
Pakistan	Multan Site	Multan	Punjab
Pakistan	Peshawar Site	Peshawar	KPK
Pakistan	Quetta Site	Quetta	Balochistan
Pakistan	Rawalpindi Site	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in scores from baseline to 3 and 6-month post-randomization
Secondary	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.	Change in scores from baseline to 3 and 6-month post-randomization
Secondary	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.	Change in scores from baseline to 3 and 6-month post-randomization
Secondary	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.	Change in scores from baseline to 3 and 6-month post-randomization
Secondary	Client Service Receipt Inventory	Detailed description of the use of health services will be collected using the Client Service Receipt Inventory (CSRI)	Change in scores from baseline to 3 and 6-month post-randomization
Secondary	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.	level of satisfaction at end of intervention i.e., 3-month post-randomization