Suicidal IdeationECMAPNCT06019650
Culturally Adapted Suicide Prevention Intervention for Older Adults
A study testing ECMAP in people with Suicidal Ideation, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
determine the efficacy of culturally adapted manual assisted brief psychological intervention for older adults (E-CMAP) with suicidal ideation Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- ECMAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to provide consent due to severe mental or physical illness.
- Unlikely to be available for outcome assessments (temporary residence)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Benazir Bhutto Hospital
Rawalpindi, Punjab Province, 203393
Tayyeba Kiran, PhD, tayyaba.kiran@pill.org.pk
About this study
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
determine the efficacy of culturally adapted manual assisted brief psychological intervention for older adults (E-CMAP) with suicidal ideation
Read the 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.
- Conditions
- Suicidal Ideation
- Being tested
- ECMAP
- Keywords
- suicidal ideation,, self-harm, older adult, elderly, ECMAP, Pakistan, LMIC
- Medical subject headings
- Suicidal Ideation, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECMAPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| E-CMAP Intervention | Experimental | 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. Receives: Behavioral: ECMAP |
| Standard Routine Care | No intervention | Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change in total scores from baseline to 3-month post randomization assessment
Secondary outcomes (8)
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
Measured: change in total scores from baseline to 3-month post randomization assessment
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.
Measured: change in total scores from baseline to 3-month post randomization assessment
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
Measured: change in total scores from baseline to 3-month post randomization assessment
Coping Resource Inventory
Participants coping skills will be assessed using the Coping Resource Inventory. Higher scored indicate better coping skills.
Measured: change in total scores from baseline to 3-month post randomization assessment
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.
Measured: level of satisfaction at end of intervention i.e., 3-month post-randomization
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.
Measured: change in total scores from baseline to 3-month post randomization assessment
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.
Measured: change in total scores from baseline to 3-month post randomization assessment
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.
Measured: change in total scores from baseline to 3-month post randomization assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Nov 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019650
- Sponsor's protocol ID
- ECMAP
- Acronym
- ECMAP
- Status last verified
- May 2024
- First submitted
- 25 Aug 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37525207
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06019650
- Acronym / sponsor ID
- ECMAP / ECMAP
- Conditions
- Suicidal Ideation
- Keywords
- suicidal ideation,, self-harm, older adult, elderly, ECMAP, Pakistan, LMIC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-CMAP Intervention | Experimental | Behavioral: ECMAPCMAP 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. |
| Standard Routine Care | No intervention | –Local medical, psychiatric and primary care services provide standard routine care according to their clinical judgment and available resources |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Unable to provide consent due to severe mental or physical illness.
- Unlikely to be available for outcome assessments (temporary residence)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECMAPThe 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. | Behavioural | E-CMAP Intervention |
Primary outcome
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.
8 secondary outcomes
Hopelessness
Time frame: change in total scores from baseline to 3-month post randomization assessment
Depression
Time frame: change in total scores from baseline to 3-month post randomization assessment
Health-related Quality of Life
Time frame: change in total scores from baseline to 3-month post randomization assessment
Coping Resource Inventory
Time frame: change in total scores from baseline to 3-month post randomization assessment
Client Satisfaction Questionaire
Time frame: level of satisfaction at end of intervention i.e., 3-month post-randomization
Service Usage
Time frame: change in total scores from baseline to 3-month post randomization assessment
Episodes of Self-harm
Time frame: change in total scores from baseline to 3-month post randomization assessment
Problem Solving Skills
Time frame: change in total scores from baseline to 3-month post randomization assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- Background: PubMed 37525207Husain 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.
- Individual participant dataSharing planned: No
Related trials for Suicidal Ideation
Enrolling by invitation
Pilot Study of a Modified Safety Planning Intervention for Elementary School-Aged Children - Main Study
Suicidal Ideation, Suicidal Behaviors
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
Alcohol Use Disorder (AUD), Suicidal Ideation
Not yet recruiting
A Pre-post Study of a Lethal Means Safety Planning Intervention for Youth at Elevated Suicide Risk in the Emergency Department
Suicidal Ideas, Suicidal Ideation
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECMAP in people with Suicidal Ideation, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tayyeba Kiran, PhD (02135871845, tayyaba.kiran@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal Ideation (time frame: change in total scores from baseline to 3-month post randomization assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.