Clinical trial NCT06019650: Culturally Adapted Suicide Prevention Intervention for Older Adults
Official title: Elderly Culturally Adapted Manual Assisted Brief Psychological Therapy (E-CMAP) for Older Adults With Suicidal Ideation: An Exploratory Randomized Controlled Trial From Pakistan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Keywords: suicidal ideation,
self-harm
older adult
elderly
ECMAP
Pakistan
LMIC
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 192
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: determine the efficacy of culturally adapted manual assisted brief psychological intervention for older adults (E-CMAP) with suicidal ideation

Detailed description: Suicide is a serious public health concern. Each year more than 800,000 people worldwide die due to suicide. Most of these (79%) are in the low and middle-income countries (LMIC), with an increased risk of suicide in ageing.

Primary Objective: To assess the effectiveness of E-CMAP compared to Treatment as Usual (TAU) as measured by reduction in suicidal ideation third month post-randomization with Beck Scale for Suicidal ideation (BSI) (Beck \& Steer, 1991) Secondary outcomes: the two groups will be compared on hopelessness, depression, quality of life, coping skills, participant satisfaction, health/social care usage, and episodes of self-harm. All variables known to be related to suicide risk.

The study will be carried out in two stages. First stage will be cultural adaptation and refinement of the intervention and second stage will be feasibility Randomised Control Trial (RCT).

Stage 1: In the first stage, the adaptation of the intervention for suicidal ideation in older adults will be carried out by a group of experts including a master trainer, a bilingual health expert, mental health professional potential user (i.e., older adults with suicidal ideation), and a senior therapist through discussion groups.

Stage 2: Feasibility randomized controlled trial (RCT) After adaptation, the intervention will be tested in a multicenter RCT to determine the efficacy of culturally adapted manual assisted brief psychological intervention for older adults/elderly (E-CMAP) with suicidal ideation.

Eligibility criteria: Inclusion Criteria:

In the context of this study, suicidal ideation is defined as; "Passive thoughts about wanting to be dead or active thoughts about killing oneself, these thoughts may include plan but not accompanied by preparatory behavior" (Griffin et al., 2020)

* 50 years and above
* Has recent history of experiencing suicidal ideation
* Participants living within the catchment area of the participating practices and hospitals.
* Capacity to give informed consent.

Exclusion Criteria:

* Unable to provide consent due to severe mental or physical illness.
* Unlikely to be available for outcome assessments (temporary residence)

Primary outcomes:
measure: Suicidal Ideation
timeFrame: change in total scores from baseline to 3-month post randomization assessment
Secondary outcomes:
measure: Hopelessness
timeFrame: change in total scores from baseline to 3-month post randomization assessment
measure: Depression
timeFrame: change in total scores from baseline to 3-month post randomization assessment
measure: Health-related Quality of Life
timeFrame: change in total scores from baseline to 3-month post randomization assessment
measure: Coping Resource Inventory
timeFrame: change in total scores from baseline to 3-month post randomization assessment
measure: Client Satisfaction Questionaire
timeFrame: level of satisfaction at end of intervention i.e., 3-month post-randomization
measure: Service Usage
timeFrame: change in total scores from baseline to 3-month post randomization assessment
measure: Episodes of Self-harm
timeFrame: change in total scores from baseline to 3-month post randomization assessment
measure: Problem Solving Skills
timeFrame: change in total scores from baseline to 3-month post randomization assessment
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Benazir Bhutto Hospital
state: Punjab
Study officials:
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.