NCT06019650

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

August 25, 2023

Last Update Submit

May 16, 2024

Conditions

Suicidal Ideation

Keywords

suicidal ideation,self-harmolder adultelderlyECMAPPakistanLMIC

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Hopelessness

    change in total scores from baseline to 3-month post randomization assessment

  • Depression

    change in total scores from baseline to 3-month post randomization assessment

  • Health-related Quality of Life

    change in total scores from baseline to 3-month post randomization assessment

  • Coping Resource Inventory

    change in total scores from baseline to 3-month post randomization assessment

  • Client Satisfaction Questionaire

    level of satisfaction at end of intervention i.e., 3-month post-randomization

  • +3 more secondary outcomes

Study Arms (2)

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.

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

Interventions

ECMAPBEHAVIORAL

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.

E-CMAP Intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 203393, Pakistan

RECRUITING

Related 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.

    PMID: 37525207BACKGROUND

MeSH Terms

Conditions

Suicidal IdeationSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

SuicideBehavioral SymptomsBehavior

Central Study Contacts

Tayyeba Kiran, PhD

CONTACT

02135871845tayyaba.kiran@pill.org.pk

Sehrish Tofique, PhD fellow

CONTACT

02135871845sehrish.tofique@pill.org.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2023

First Posted

August 31, 2023

Study Start

November 1, 2023

Primary Completion

December 30, 2024

Study Completion

June 30, 2025

Last Updated

May 17, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)