The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Culturally Adapted Suicide Prevention Intervention for Older Adults (ECMAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06019650
Recruitment Status : Recruiting
First Posted : August 31, 2023
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
determine the efficacy of culturally adapted manual assisted brief psychological intervention for older adults (E-CMAP) with suicidal ideation

Condition or disease Intervention/treatment Phase
Suicidal Ideation Behavioral: ECMAP Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 1, 2023
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: E-CMAP Intervention
CMAP 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.
 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.
No Intervention: Standard Routine Care
Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Suicidal Ideation [ Time Frame: change in total scores from baseline to 3-month post randomization assessment ]
    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.


Secondary Outcome Measures :
  1. Hopelessness [ Time Frame: change in total scores from baseline to 3-month post randomization assessment ]
    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

  2. Depression [ Time Frame: change in total scores from baseline to 3-month post randomization assessment ]
    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.

  3. Health-related Quality of Life [ Time Frame: change in total scores from baseline to 3-month post randomization assessment ]
    Participants Health related quality of life will be assessed using the EQ-5D- 5L. Higher scores indicate better health related quality of life

  4. Coping Resource Inventory [ Time Frame: change in total scores from baseline to 3-month post randomization assessment ]
    Participants coping skills will be assessed using the Coping Resource Inventory. Higher scored indicate better coping skills.

  5. Client Satisfaction Questionaire [ Time Frame: level of satisfaction at end of intervention i.e., 3-month post-randomization ]
    Participant satisfaction with services will be assessed using the Client Satisfaction Questionnaire. Higher scores indicate greater level of satisfaction with the services.

  6. Service Usage [ Time Frame: change in total scores from baseline to 3-month post randomization assessment ]
    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.

  7. Episodes of Self-harm [ Time Frame: change in total scores from baseline to 3-month post randomization assessment ]
    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.

  8. Problem Solving Skills [ Time Frame: change in total scores from baseline to 3-month post randomization assessment ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06019650


Contacts
Layout table for location contacts
Contact: Tayyeba Kiran, PhD 02135871845 tayyaba.kiran@pill.org.pk
Contact: Sehrish Tofique, PhD fellow 02135871845 sehrish.tofique@pill.org.pk

Locations
Layout table for location information
Pakistan
Benazir Bhutto Hospital Recruiting
Rawalpindi, Punjab, Pakistan, 203393
Contact: Tayyeba Kiran, PhD       tayyaba.kiran@pill.org.pk   
Sponsors and Collaborators
Pakistan Institute of Living and Learning
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT06019650    
Other Study ID Numbers: ECMAP
First Posted: August 31, 2023    Key Record Dates
Last Update Posted: May 20, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pakistan Institute of Living and Learning:
suicidal ideation,
self-harm
older adult
elderly
 ECMAP
Pakistan
LMIC
Additional relevant MeSH terms:
Layout table for MeSH terms
Suicidal Ideation
Suicide
Self-Injurious Behavior
Behavioral Symptoms