Suicidal IdeationNCT05453864
CMAP Plus Trauma-focused Cognitive Behavior Therapy for Suicidal Ideation Among Burn Survivors
A study testing CMAP Plus TFCBT in people with Suicidal Ideation and Trauma, Psychological, run by Pakistan Institute of Living and Learning.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicidal Ideation, Trauma, Psychological
- What is being tested?
- CMAP Plus TFCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2024to 30 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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
No sites are listed yet.
Nasim Chaudhry contact
About this study
Official title: Culturally Adapted Manually Assisted Brief Problem-Solving Interventions Plus Trauma-focused Cognitive Behavior Therapy (CMAP Plus TF-CBT) for Suicidal Ideation Among Burn Survivors
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.
Read the detailed description
The study will be conducted in two stages. Stage 1 is to adapt the existing CMAP intervention for burn survivors and integrate it with existing culturally adapted TFCBT intervention. Stage 2 is to test the feasibility and acceptability of study intervention in a Randomised Controlled Trial (RCT).
In the first stage, the adaptation of the intervention will be carried out by a group of experts including bilingual health experts such as psychiatrists and psychologists, the potential users (i.e., burn survivors with Suicidal ideation), and experienced CBT therapists. The expert group will involve in an iterative process of discussion for the adaptation of the intervention including the development of the integrated intervention manual.
Stage 2 will be a rater blind, two-arm, multi-site, feasibility randomized controlled trial (RCT) of CMAP Plus TF CBT for burn survivors with suicidal ideation randomized either to 1) CMAP Plus TF CBT added to Treatment As Usual (TAU) or 2) TAU alone.
A total of N=80 burn survivors with suicidal ideation will be recruited from hospitals (Burn Injuries Units) in Karachi, Lahore, Rawalpindi, Quetta, Peshawar, Multan, and Hyderabad, Pakistan. Each participant in the intervention arm will receive 8 individual sessions of CMAP Plus TFCBT over 12 weeks. Assessment measures will be administered before and after the intervention in the 12th week. All assessments will be rater blind. After post-assessments, a purposefully selected subset (stratified by age \& gender) of participants will be invited for qualitative interviews (upto 15) to explore their experiences and satisfaction with the intervention.
- Conditions
- Suicidal Ideation, Trauma, Psychological
- Being tested
- CMAP Plus TFCBT
- Medical subject headings
- Suicidal Ideation, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMAP Plus TFCBTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to 12th week (end of intervention)
Secondary outcomes (10)
Beck Scale for Suicide Ideation
This is a 19-item instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviors, and specificity of a patient's thoughts to kill him/herself during the past week.
Measured: From baseline to 12th week (end of intervention)
The Brief Posttraumatic Growth Inventory
This is a 21-item measure of growth that uses a 6-point Likert-type response scale. It helps to assess individual's growth by using retrospective self-reported items.
Measured: From baseline to 12th week (end of intervention)
Suicide Attempt and Self-Harm
This consists of four questions measuring the previous suicide attempt and the presence of self-harm. The scale was taken from the original Self-Harm Questionnaire
Measured: From baseline to 12th week (end of intervention)
Beck Depression Inventory
This is 21-items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression.
Measured: From baseline to 12th week (end of intervention)
Beck Hopelessness Scale
This instrument is designed to measure three aspects of hopelessness, feelings about the future, loss of motivation and expectations.
Measured: From baseline to 12th week (end of intervention)
The Generalised Anxiety Disorder
This is a 0-3 point rating scale with seven-items to assess common anxiety symptoms of generalised anxiety, panic, social anxiety, and PTSD.
Measured: From baseline to 12th week (end of intervention)
Euro-Qol-5 Dimensions scale
It's a standardised instrument to measure participants' health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/ discomfort, and anxiety/ depression)
Measured: From baseline to 12th week (end of intervention)
Problem Solving Inventory
This is one of the most widely used self-report inventories in problem solving.
Measured: From baseline to 12th week (end of intervention)
The coping with burns questionnaire
This scale is to measure coping after discharge from burns unit. Most items in this scale are burn-related and alluded to specific difficulties that burn patients might experience.
Measured: From baseline to 12th week (end of intervention)
Burn Specific Health Scale-Brief
The Burn Specific Health Scale (BSHS) assess burn specific health status of participants.
Measured: From baseline to 12th week (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Jun 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 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
- NCT05453864
- Sponsor's protocol ID
- SAHAR M- CMAP Plus TFCBT-004
- Status last verified
- May 2024
- First submitted
- 7 Jul 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Culturally Adapted Manually Assisted Brief Problem-Solving Interventions Plus Trauma-focused Cognitive Behavior Therapy (CMAP Plus TF-CBT) for Suicidal Ideation Among Burn Survivors
- ClinicalTrials.gov ID
- NCT05453864
- Acronym / sponsor ID
- SAHAR M- CMAP Plus TFCBT-004
- Conditions
- Suicidal Ideation, Trauma, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 12 Jul 2022 (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.
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.
Detailed description
The study will be conducted in two stages. Stage 1 is to adapt the existing CMAP intervention for burn survivors and integrate it with existing culturally adapted TFCBT intervention. Stage 2 is to test the feasibility and acceptability of study intervention in a Randomised Controlled Trial (RCT).
In the first stage, the adaptation of the intervention will be carried out by a group of experts including bilingual health experts such as psychiatrists and psychologists, the potential users (i.e., burn survivors with Suicidal ideation), and experienced CBT therapists. The expert group will involve in an iterative process of discussion for the adaptation of the intervention including the development of the integrated intervention manual.
Stage 2 will be a rater blind, two-arm, multi-site, feasibility randomized controlled trial (RCT) of CMAP Plus TF CBT for burn survivors with suicidal ideation randomized either to 1) CMAP Plus TF CBT added to Treatment As Usual (TAU) or 2) TAU alone.
A total of N=80 burn survivors with suicidal ideation will be recruited from hospitals (Burn Injuries Units) in Karachi, Lahore, Rawalpindi, Quetta, Peshawar, Multan, and Hyderabad, Pakistan. Each participant in the intervention arm will receive 8 individual sessions of CMAP Plus TFCBT over 12 weeks. Assessment measures will be administered before and after the intervention in the 12th week. All assessments will be rater blind. After post-assessments, a purposefully selected subset (stratified by age \& gender) of participants will be invited for qualitative interviews (upto 15) to explore their experiences and satisfaction with the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMAP Plus TFCBT | Experimental | Behavioral: CMAP Plus TFCBTThis 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). |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| CMAP Plus TFCBTThis 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. | Behavioural | CMAP Plus TFCBT |
Primary outcome
Feasibility Indicator
Time frame: From baseline to 12th week (end of intervention)
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.
Acceptability Indicator
Time frame: From baseline to 12th week (end of intervention)
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.
10 secondary outcomes
Beck Scale for Suicide Ideation
Time frame: From baseline to 12th week (end of intervention)
The Brief Posttraumatic Growth Inventory
Time frame: From baseline to 12th week (end of intervention)
Suicide Attempt and Self-Harm
Time frame: From baseline to 12th week (end of intervention)
Beck Depression Inventory
Time frame: From baseline to 12th week (end of intervention)
Beck Hopelessness Scale
Time frame: From baseline to 12th week (end of intervention)
The Generalised Anxiety Disorder
Time frame: From baseline to 12th week (end of intervention)
Euro-Qol-5 Dimensions scale
Time frame: From baseline to 12th week (end of intervention)
Problem Solving Inventory
Time frame: From baseline to 12th week (end of intervention)
The coping with burns questionnaire
Time frame: From baseline to 12th week (end of intervention)
Burn Specific Health Scale-Brief
Time frame: From baseline to 12th week (end of intervention)
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.
- Individual participant dataSharing planned: No
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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.
Nasim Chaudhry contact
Questions about this trial
What is this clinical trial studying?
A study testing CMAP Plus TFCBT in people with Suicidal Ideation and Trauma, Psychological, run by Pakistan Institute of Living and Learning.
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 4 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.
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 MUQADDAS ASIF (042-35842310, muqaddas.asif@pill.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Indicator (time frame: From baseline to 12th week (end of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.