Self HarmC-MAPNCT02742922
Multicenter Study to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP)
A study testing Culturally adapted therapy (C-MAP) in people with Self Harm, run by Pakistan Institute of Living and Learning at 7 sites in Pakistan.
Trial summary
To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Harm
- What is being tested?
- Culturally adapted therapy (C-MAP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 901 participants
- Where
- 7 sitesPakistan
- Study dates
- 27 Apr 2016to 30 Oct 2019
- 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
- Patients over the age of 18 years will be considered eligible for the study.
- Participants will have to be living within the catchment area of the participating practices and hospitals.
- Not needing inpatient psychiatric treatment.
Who cannot join
- Temporary resident unlikely to be available for follow up.
- Participants with ICD-I0 mental disorder; due to a general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability.
- Unable to engage, participate or respond to the research questionnaires.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Pakistan7 sites
Civil Hospital
Karachi, Sindh, 72400
Abbasi Hospital
Karachi, Sindh
Jinah Hospital
Lahore, Punjab Province
Services Hospital
Lahore, Punjab Province
Khyber Teaching Hospital
Peshawar, KPK
Bolan Medical Complex
Quetta, Balochistan
Rawalpindi General Hospital
Rawalpindi, Punjab Province
About this study
Official title: Multicenter RCT to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP) in Patients With a History of Self-harm
To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm
Read the detailed description
Suicide is a serious global public health issue, ranked amongst the leading causes of death in many countries. Most of these (75%) are in the low and middle income countries (LAMIC) and globally suicide is the second leading cause of death in young people 15-29 years of age. There is no official data on suicide from Pakistan, a conservative South Asian Islamic country with historically low suicide rates. Both suicide and attempted suicide are illegal acts, as well as socially and religiously condemned, however, there is accumulating evidence that suicide rates have been gradually increasing in Pakistan over the last few years.
The culturally adapted psychological intervention C-MAP utilizes problem solving components within a brief intervention that can be widely utilized in clinical practice. Our previous pilot trial in Karachi shows the efficacy of CBT based intervention(C-MAP) in people who had recently self harmed.The findings from this work have highlighted the applicability of such an intervention to health services in Pakistan for patients who present after a self-harm episode
- Conditions
- Self Harm
- Being tested
- Culturally adapted therapy (C-MAP)
- Keywords
- self harm, culturally adapted therapy, problem solving therapy, low and middle income countries
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally adapted therapy (C-MAP)Behavioural
Also called psycho social intervention
C-MAP is a brief problem focused therapy, comprising of six sessions delivered within three months. C-MAP is a manual assisted intervention based on the principles of CBT .In this intervention there is an evaluation of the self-harm attempt, crisis skills, problem solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies.
| Study group | Role | What they receive |
|---|---|---|
| Culturally adapted therapy (C-MAP) | Experimental | Culturally adapted manual assisted (C-MAP) brief problem solving therapy Receives: Behavioral: Culturally adapted therapy (C-MAP) |
| Treatment as usual | No intervention | This arm will receive no intervention only TAٓU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Attempt Self Injury Interview SASII
Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII)
Measured: up to 12th months
Secondary outcomes (6)
Beck Scale for Suicidal ideation (BSI).
This is a 19-item instrument for detecting and measuring the current intensity of the patients' specific attitudes, behaviours, and specificity of a patient's thoughts to kill him/herself during the past week.
Measured: Baseline, 3, 6, 9 and 12th months
Beck Hopelessness Scale
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression
Measured: Baseline,3rd,6th,9th and 12th months
Beck Depression Inventory (BDI)
This is a 21 items scale measuring symptoms of depression. Higher scores on the scale indicate greater severity of depression
Measured: Baseline,3rd,6th,9th and 12th months
EuroQol-5 Dimensions (EQ5-D)
A standardised instrument to measure health status and associated population utility weights. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/ discomfort and anxiety/ depression).
Measured: Baseline,3rd,6th,9th and 12th months
Coping Resource Inventory (CRI).
To assess the coping resources to manage stress available to an individual.
Measured: Baseline,3rd,6th,9th and 12th months
Client Satisfaction Questionnaire (CSQ).
The participants will rate their satisfaction with treatment by using the CSQ.
Measured: Baseline,3rd,6th,9th and 12th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study start27 Apr 2016
- Primary completion30 Jul 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Self HarmStudies 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
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Dow University of Health Sciences, Karachi Medical and Dental College, Services Hospital, Lahore, Peshawar Medical College
- Responsible party
- Principal investigator, Dr. Nusrat Husain, University of Manchester
- Investigators
- Nusrat Husian, MD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742922
- Sponsor's protocol ID
- PILL-CMAP-001
- Acronym
- C-MAP
- Status last verified
- May 2023
- First submitted
- 19 Feb 2016
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 37525207Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter RCT to Evaluate the Clinical and Cost-effectiveness of a Culturally Adapted Therapy (C-MAP) in Patients With a History of Self-harm
- ClinicalTrials.gov ID
- NCT02742922
- Acronym / sponsor ID
- C-MAP / PILL-CMAP-001
- Conditions
- Self Harm
- Keywords
- self harm, culturally adapted therapy, problem solving therapy, low and middle income countries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- University of Manchester, Dow University of Health Sciences, Karachi Medical and Dental College, Services Hospital, Lahore, Peshawar Medical College
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 19 Apr 2016 (estimated)
- 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.
To evaluate the clinical and cost-effectiveness of a culturally adapted therapy (C-MAP) in patients with a history of self-harm
Detailed description
Suicide is a serious global public health issue, ranked amongst the leading causes of death in many countries. Most of these (75%) are in the low and middle income countries (LAMIC) and globally suicide is the second leading cause of death in young people 15-29 years of age. There is no official data on suicide from Pakistan, a conservative South Asian Islamic country with historically low suicide rates. Both suicide and attempted suicide are illegal acts, as well as socially and religiously condemned, however, there is accumulating evidence that suicide rates have been gradually increasing in Pakistan over the last few years.
The culturally adapted psychological intervention C-MAP utilizes problem solving components within a brief intervention that can be widely utilized in clinical practice. Our previous pilot trial in Karachi shows the efficacy of CBT based intervention(C-MAP) in people who had recently self harmed.The findings from this work have highlighted the applicability of such an intervention to health services in Pakistan for patients who present after a self-harm episode
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted therapy (C-MAP) | Experimental | Behavioral: Culturally adapted therapy (C-MAP)Culturally adapted manual assisted (C-MAP) brief problem solving therapy |
| Treatment as usual | No intervention | –This arm will receive no intervention only TAٓU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over the age of 18 years will be considered eligible for the study.
- Participants will have to be living within the catchment area of the participating practices and hospitals.
- Not needing inpatient psychiatric treatment.
Key exclusion criteria (3 listed)
- Temporary resident unlikely to be available for follow up.
- Participants with ICD-I0 mental disorder; due to a general medical condition or substance misuse, dementia, delirium, alcohol or drug dependence, schizophrenia, bipolar disorder, learning disability.
- Unable to engage, participate or respond to the research questionnaires.
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 |
|---|---|---|
| Culturally adapted therapy (C-MAP)Also: psycho social interventionC-MAP is a brief problem focused therapy, comprising of six sessions delivered within three months. C-MAP is a manual assisted intervention based on the principles of CBT .In this intervention there is an evaluation of the self-harm attempt, crisis skills, problem solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies. | Behavioural | Culturally adapted therapy (C-MAP) |
Primary outcome
Suicide Attempt Self Injury Interview SASII
Time frame: up to 12th months
Repetition rate of self-harm measured by adapted Suicide Attempt Self-Injury Interview (SASII)
6 secondary outcomes
Beck Scale for Suicidal ideation (BSI).
Time frame: Baseline, 3, 6, 9 and 12th months
Beck Hopelessness Scale
Time frame: Baseline,3rd,6th,9th and 12th months
Beck Depression Inventory (BDI)
Time frame: Baseline,3rd,6th,9th and 12th months
EuroQol-5 Dimensions (EQ5-D)
Time frame: Baseline,3rd,6th,9th and 12th months
Coping Resource Inventory (CRI).
Time frame: Baseline,3rd,6th,9th and 12th months
Client Satisfaction Questionnaire (CSQ).
Time frame: Baseline,3rd,6th,9th and 12th months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Derived from this study: 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.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Pakistan Institute of Learning and LivingLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Nusrat Husian, MD principal investigator
University of Manchester
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted therapy (C-MAP) in people with Self Harm, run by Pakistan Institute of Living and Learning at 7 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide Attempt Self Injury Interview SASII (time frame: up to 12th months). 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 NCT02742922, which also lists 2 linked publications.
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 19 May 2023.