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Culturally Adapted Suicide Prevention Intervention for Older Adults (ECMAP)

Primary Purpose

Suicidal Ideation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
ECMAP
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicidal Ideation focused on measuring suicidal ideation,, self-harm, older adult, elderly, ECMAP, Pakistan, LMIC

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Benazir Bhutto Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Standard Routine Care

Arm Description

C-MAP is a culturally adapted brief problem-focused therapy, based on the principles of CBT which has been adapted with permission from a self-help guide called "Life after self-harm"(Schmidt & Davidson, 2004). This intervention includes evaluation of the self-harm attempt, crisis skills, problem-solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies.

Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources

Outcomes

Primary Outcome Measures

Suicidal Ideation
Participants suicidal ideation will be assessed using the Beck scale for suicidal ideation. Higher scores on the questionnaire indicate greater severeity of suicidal ideation (BSI) (Beck & Steer, 1991)

Secondary Outcome Measures

Hopelessness
Participants feelings of hopelessness will be assessed using the Beck Hopelessness Scale (BHS) (Beck & Steer, 1988). Higher scores indicate greater severity of hopelessness.
Depression
Participants severity of depression will be assessed using the Beck Depression Inventory (BDI) (Beck, Ward, & Mendelson, 1961). Higher scores indicate greater severity of depression.
Health-related Quality of Life
Participants Health related quality of life will be assessed using the EQ-5D- 5L (Herdman et al., 2011). Higher scores indicate better health related quality of life
Coping Resource Inventory
Participants coping skills will be assessed using the Coping Resource Inventory (CRI) (Martin & Hammer, 1988). Higher scored indicate better coping skills.
Client Satisfaction Questionaire
Participant satisfaction with services will be assessed using the Client Satisfaction Questionnaire (CSQ) (Attkisson & Zwick, 1982). Higher scores indicate greater level of satisfaction with the services.
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 (CSRI) (Beecham & Knapp, 2001)
Episodes of Self-harm
Episodes of Self-harm will be assessed using the Suicide attempt self -injury interview (SASII) (Linehan, Comtois, Brown, Heard, & Wagner, 2006). This is the semi-structured instrument to assess diffeent aspects of episode of self-harm
Problem Solving Skills
Participants problem Solving skills will be assessed using Problem solving Inventory (PSI) (Heppner & Petersen, 1982). Higher scores indicate better problem solving skills.

Full Information

First Posted
August 25, 2023
Last Updated
August 25, 2023
Sponsor
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT06019650
Brief Title
Culturally Adapted Suicide Prevention Intervention for Older Adults
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal Ideation
Keywords
suicidal ideation,, self-harm, older adult, elderly, ECMAP, Pakistan, LMIC

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
C-MAP is a culturally adapted brief problem-focused therapy, based on the principles of CBT which has been adapted with permission from a self-help guide called "Life after self-harm"(Schmidt & Davidson, 2004). This intervention includes evaluation of the self-harm attempt, crisis skills, problem-solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies.
Arm Title
Standard Routine Care
Arm Type
No Intervention
Arm Description
Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources
Intervention Type
Behavioral
Intervention Name(s)
ECMAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Suicidal Ideation
Description
Participants suicidal ideation will be assessed using the Beck scale for suicidal ideation. Higher scores on the questionnaire indicate greater severeity of suicidal ideation (BSI) (Beck & Steer, 1991)
Time Frame
change in total scores from baseline to 3-month post randomization assessment
Secondary Outcome Measure Information:
Title
Hopelessness
Description
Participants feelings of hopelessness will be assessed using the Beck Hopelessness Scale (BHS) (Beck & Steer, 1988). Higher scores indicate greater severity of hopelessness.
Time Frame
change in total scores from baseline to 3-month post randomization assessment
Title
Depression
Description
Participants severity of depression will be assessed using the Beck Depression Inventory (BDI) (Beck, Ward, & Mendelson, 1961). Higher scores indicate greater severity of depression.
Time Frame
change in total scores from baseline to 3-month post randomization assessment
Title
Health-related Quality of Life
Description
Participants Health related quality of life will be assessed using the EQ-5D- 5L (Herdman et al., 2011). Higher scores indicate better health related quality of life
Time Frame
change in total scores from baseline to 3-month post randomization assessment
Title
Coping Resource Inventory
Description
Participants coping skills will be assessed using the Coping Resource Inventory (CRI) (Martin & Hammer, 1988). Higher scored indicate better coping skills.
Time Frame
change in total scores from baseline to 3-month post randomization assessment
Title
Client Satisfaction Questionaire
Description
Participant satisfaction with services will be assessed using the Client Satisfaction Questionnaire (CSQ) (Attkisson & Zwick, 1982). Higher scores indicate greater level of satisfaction with the services.
Time Frame
level of satisfaction at end of intervention i.e., 3-month post-randomization
Title
Service Usage
Description
Service usage (including formal (GPs/ other doctor and informal sector such as faith healers/imams) will be assessed using client service receipt inventory (CSRI) (Beecham & Knapp, 2001)
Time Frame
change in total scores from baseline to 3-month post randomization assessment
Title
Episodes of Self-harm
Description
Episodes of Self-harm will be assessed using the Suicide attempt self -injury interview (SASII) (Linehan, Comtois, Brown, Heard, & Wagner, 2006). This is the semi-structured instrument to assess diffeent aspects of episode of self-harm
Time Frame
change in total scores from baseline to 3-month post randomization assessment
Title
Problem Solving Skills
Description
Participants problem Solving skills will be assessed using Problem solving Inventory (PSI) (Heppner & Petersen, 1982). Higher scores indicate better problem solving skills.
Time Frame
change in total scores from baseline to 3-month post randomization assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tayyeba Kiran, PhD
Phone
02135871845
Email
tayyaba.kiran@pill.org.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Sehrish Tofique, PhD fellow
Phone
02135871845
Email
sehrish.tofique@pill.org.pk
Facility Information:
Facility Name
Benazir Bhutto Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
203393
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tayyeba Kiran, PhD
Email
tayyaba.kiran@pill.org.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
37525207
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.
Results Reference
background

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Culturally Adapted Suicide Prevention Intervention for Older Adults

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