Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention

NCT06019689 | Not Yet Recruiting DMC

• 1 other identifier: PILL-CAMI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

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.

Conditions

Suicidal Ideation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Depression

  Change in scores from baseline to 3 and 6-month post-randomization

• Hopelessness

  Change in scores from baseline to 3 and 6-month post-randomization

• Health-related quality of life

  Change in scores from baseline to 3 and 6-month post-randomization

• Client Service Receipt Inventory

  Change in scores from baseline to 3 and 6-month post-randomization

• Client Satisfaction Questionnaire

  level of satisfaction at end of intervention i.e., 3-month post-randomization

Study Arms (2)

Intervention

EXPERIMENTAL

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

Standard Routine Care

NO INTERVENTION

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)

Interventions

CAMI 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.

Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (7)

Quetta Site

Quetta, Balochistan, Pakistan

Location

Peshawar Site

Peshawar, KPK, Pakistan

Location

Lahore Site

Lahore, Punjab Province, Pakistan

Location

Multan Site

Multan, Punjab Province, Pakistan

Location

Rawalpindi Site

Rawalpindi, Punjab Province, Pakistan

Location

Hyderabad Site

Hyderābād, Sindh, Pakistan

Location

Karachi Site

Karachi, Sindh, 75350, Pakistan

Location

Related 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.

  PMID: 37525207 BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Suicide; Behavioral Symptoms; Behavior

Study Officials

• Nasim Chaudhry, MRC Psych, FRC Psych

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nasim Chaudhry, MRC Psych, FRC Psych, MD

CONTACT

02135871845; nasim.chaudhry@pill.org.pk

Tayyeba Kiran, PhD

CONTACT

03328262142; tayyaba.kiran@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicenter exploratory RCT

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: May 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (7)