Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention

NCT ID: NCT06019689

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-06-30

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.

Conditions

Suicidal Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

CAMI

Intervention Type: BEHAVIORAL

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.

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nasim Chaudhry, MRC Psych, FRC Psych

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Locations

Quetta Site

Quetta, Balochistan, Pakistan

Peshawar Site

Peshawar, KPK, Pakistan

Lahore Site

Lahore, Punjab Province, Pakistan

Multan Site

Multan, Punjab Province, Pakistan

Rawalpindi Site

Rawalpindi, Punjab Province, Pakistan

Hyderabad Site

Hyderābād, Sindh, Pakistan

Karachi Site

Karachi, Sindh, Pakistan

Countries

Pakistan

Central Contacts

Nasim Chaudhry, MRC Psych, FRC Psych, MD

Role: CONTACT

nasim.chaudhry@pill.org.pk

02135871845

Tayyeba Kiran, PhD

Role: CONTACT

tayyaba.kiran@pill.org.pk

03328262142

Facility Contacts

umair

Role: primary

Ayesha Khaliq, MS

Role: primary

Zehra Nigah, Mphil

Role: primary

Samia Shahid, BS

Role: primary

Faster Gill

Role: primary

Sehrish Tofique

Role: primary

03242939563

References

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.

Reference Type: BACKGROUND

PMID: 37525207 (View on PubMed)

Other Identifiers

PILL-CAMI

Identifier Type: -

Identifier Source: org_study_id