Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention (CAMI)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal Ideation
• Intervention / Treatment: Behavioral: CAMI

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nasim Chaudhry, MRC Psych, FRC Psych, MD; Phone Number: 02135871845; Email: nasim.chaudhry@pill.org.pk
• Study Contact Backup: Name: Tayyeba Kiran, PhD; Phone Number: 03328262142; Email: tayyaba.kiran@pill.org.pk

Study Locations

• Pakistan
  • Balochistan
    • Quetta, Balochistan, Pakistan
      • Quetta Site
  • KPK
    • Peshawar, KPK, Pakistan
      • Peshawar Site
      • Contact: umair
  • Punjab
    • Lahore, Punjab, Pakistan
      • Lahore site
      • Contact: Ayesha Khaliq, MS
    • Multan, Punjab, Pakistan
      • Multan Site
      • Contact: Zehra Nigah, Mphil
    • Rawalpindi, Punjab, Pakistan
      • Rawalpindi Site
      • Contact: Samia Shahid, BS
  • Sindh
    • Hyderabad, Sindh, Pakistan
      • Hyderabad Site
      • Contact: Faster Gill
    • Karachi, Sindh, Pakistan, 75350
      • Karachi Site
      • Contact: Sehrish Tofique; Phone Number: 03242939563

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
No Intervention: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Pakistan Institute of Living and Learning
• Investigators: Principal Investigator: Nasim Chaudhry, MRC Psych, FRC Psych, Pakistan Institute of Living and Learning

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 30, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: CBT; LMIC; suicidal ideation; Pakistan; cultural adaptation; self-harm; Mobile intervention; Problem-solving
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation
• Other Study ID Numbers: PILL-CAMI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No