Culturally Adapted Suicide Prevention Intervention for Older Adults

Suicidal Ideation Clinical Trial

— ECMAP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019650
• Other study ID #: ECMAP
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Pakistan Institute of Living and Learning
• Contact: Tayyeba Kiran, PhD
• Phone: 02135871845
• Email: tayyaba.kiran[@]pill.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Behavioral:
• ECMAP
The therapist will deliver 12-week training program comprised of 6 sessions at the participant's home/outpatient clinic depending upon the participants' choice within 3 months. The first two sessions will be offered weekly and then fortnightly.

Locations

Country	Name	City	State
Pakistan	Benazir Bhutto Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suicidal Ideation	Participants suicidal ideation will be assessed using the Beck scale for suicidal ideation. Higher scores on the questionnaire indicate greater severity of suicidal ideation. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe.	change in total scores from baseline to 3-month post randomization assessment
Secondary	Hopelessness	Participants feelings of hopelessness will be assessed using the Beck Hopelessness Scale. Higher scores indicate greater severity of hopelessness. Scores ranging from: 0 to 3 as are considered within the normal range, 4 to 8 identify mild hopelessness, scores from 9 to 14 identify moderate hopelessness, and scores greater than 14 identify severe hopelessness	change in total scores from baseline to 3-month post randomization assessment
Secondary	Depression	Participants severity of depression will be assessed using the Beck Depression Inventory. Higher scores indicate greater severity of depression. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.	change in total scores from baseline to 3-month post randomization assessment
Secondary	Health-related Quality of Life	Participants Health related quality of life will be assessed using the EQ-5D- 5L. Higher scores indicate better health related quality of life	change in total scores from baseline to 3-month post randomization assessment
Secondary	Coping Resource Inventory	Participants coping skills will be assessed using the Coping Resource Inventory. Higher scored indicate better coping skills.	change in total scores from baseline to 3-month post randomization assessment
Secondary	Client Satisfaction Questionaire	Participant satisfaction with services will be assessed using the Client Satisfaction Questionnaire. Higher scores indicate greater level of satisfaction with the services.	level of satisfaction at end of intervention i.e., 3-month post-randomization
Secondary	Service Usage	Service usage (including formal (GPs/ other doctor and informal sector such as faith healers/imams) will be assessed using client service receipt inventory. There are no score ranges for this scale.	change in total scores from baseline to 3-month post randomization assessment
Secondary	Episodes of Self-harm	Episodes of Self-harm will be assessed using the Suicide attempt self -injury interview. This is the semi-structured instrument to assess different aspects of episode of self-harm. This scale does not have any cut-off or score ranges.	change in total scores from baseline to 3-month post randomization assessment
Secondary	Problem Solving Skills	Participants problem Solving skills will be assessed using Problem solving Inventory. Higher scores indicate better problem solving skills. The possible total scale score of PSI ranges between 32 and 192.	change in total scores from baseline to 3-month post randomization assessment