CMAP Plus Trauma-focused Cognitive Behavior Therapy for Suicidal Ideation Among Burn Survivors

NCT05453864 | Not Yet Recruiting DMC

• 1 other identifier: SAHAR M- CMAP Plus TFCBT-004
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to determine whether CMAP Plus TFBCT is feasible and acceptable for burn survivors with suicidal ideations. To identify any barriers to the recruitment of participants. To determine initial data for the primary outcome measure to perform a sample size calculation for a larger trial.

Conditions

Suicidal Ideation; Trauma, Psychological

Outcome Measures

Primary Outcomes (2)

• Feasibility Indicator

  The feasibility will be determined by collating data on recruitment and retention rates. The success criterion of feasibility will be to recruit \> 50% of eligible participants and retain 70% of participants.

  From baseline to 12th week (end of intervention)

• Acceptability Indicator

  Intervention acceptability will be assessed using data on attendance. The criterion for acceptability is a mean attendance rate of \>70% of sessions. This will also be determined by participant's views on acceptability of intervention content, mode of delivery etc. thorough qualitative interviews.

  From baseline to 12th week (end of intervention)

Secondary Outcomes (10)

• Beck Scale for Suicide Ideation

  From baseline to 12th week (end of intervention)

• The Brief Posttraumatic Growth Inventory

  From baseline to 12th week (end of intervention)

• Suicide Attempt and Self-Harm

  From baseline to 12th week (end of intervention)

• Beck Depression Inventory

  From baseline to 12th week (end of intervention)

• Beck Hopelessness Scale

  From baseline to 12th week (end of intervention)

Study Arms (2)

CMAP Plus TFCBT

EXPERIMENTAL

This intervention is a manual-assisted intervention, which will include two existing culturally adapted psychological interventions 1) Culturally Adapted Manual Assisted Psychological (CMAP), 2) Self-help manual for trauma - BASID Ki Kahani. Both interventions are based on the principles of Cognitive behavioural therapy (CBT).

Behavioral: CMAP Plus TFCBT

Treatment As Usual (TAU)

NO INTERVENTION

This will be already receiving local medical, psychiatric and primary care services providing standard routine care to the participants.

Interventions

CMAP Plus TFCBT BEHAVIORAL

This will include 8 individual sessions of CMAP Plus TFCBT delivered by a trained therapist over a period of 12 weeks. Each session will last between 45 to 60 minutes.

CMAP Plus TFCBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 and above
• Had burn injury and identified for having suicidal ideation measures with Beck scale for suicidal Ideation (BSI)
• Able to give informed consent
• Living within the catchment areas of participating hospitals

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)

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

MeSH Terms

Conditions

Suicidal Ideation; Psychological Trauma

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

MUQADDAS ASIF

CONTACT

042-35842310; muqaddas.asif@pill.org.pk

Nasim Chaudhry

CONTACT

Study Design

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

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 12, 2022
• Study Start: June 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share