Clinical trial NCT06019689: Culturally Adapted Manual-assisted Problem Solving Training Based Mobile Intervention
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Keywords: self-harm
suicidal ideation
Mobile intervention
cultural adaptation
Pakistan
LMIC
Problem-solving
CBT
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter exploratory RCT
Primary purpose: PREVENTION

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.

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 outcomes:
measure: Suicide Ideation .
timeFrame: Change in scores from baseline to 3 and 6-month post-randomization
Secondary outcomes:
measure: Depression
timeFrame: Change in scores from baseline to 3 and 6-month post-randomization
measure: Hopelessness
timeFrame: Change in scores from baseline to 3 and 6-month post-randomization
measure: Health-related quality of life
timeFrame: Change in scores from baseline to 3 and 6-month post-randomization
measure: Client Service Receipt Inventory
timeFrame: Change in scores from baseline to 3 and 6-month post-randomization
measure: Client Satisfaction Questionnaire
timeFrame: level of satisfaction at end of intervention i.e., 3-month post-randomization
Other outcomes:
Locations:
city: Quetta
country: Pakistan
facility: Quetta Site
state: Balochistan
city: Peshawar
country: Pakistan
facility: Peshawar Site
state: KPK
city: Lahore
country: Pakistan
facility: Lahore Site
state: Punjab
city: Multan
country: Pakistan
facility: Multan Site
state: Punjab
city: Rawalpindi
country: Pakistan
facility: Rawalpindi Site
state: Punjab
city: Hyderabad
country: Pakistan
facility: Hyderabad Site
state: Sindh
city: Karachi
country: Pakistan
facility: Karachi Site
state: Sindh
Study officials:
affiliation: Pakistan Institute of Living and Learning
name: Nasim Chaudhry, MRC Psych, FRC Psych
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.