Self HarmCMAP PlusNCT05476601
CMAP Plus Intervention for Self-harm in Individuals With Substance Use Disorder in Pakistan
A study testing CMAP Plus in people with Self Harm and Substance-Related Disorders, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
Objectives: To determine the feasibility and acceptability of the culturally adapted CMAP Plus CBT based Motivational Interviewing (MICBT) called CMAP Plus for self-harm in individuals with substance use disorder (SUD) in a feasibility randomised controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Harm, Substance-Related Disorders
- What is being tested?
- CMAP Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 12 May 2026
- 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.
- Individuals diagnosed with SUD on DSM-5 criteria of mental disorders.
- Having episodes of self-harm in last three months defined as a deliberate act to harm one's own body including but not limited to self-cutting, self-biting, self-poisoning, self-scratching, self-burning, self-hitting, pulling hair etc. assessed by deliberate self-harm inventory.
- Capable to give informed consent.
- Those who have completed detoxification process.
Who cannot join
- Participants with DSM-5 criteria of mental disorder other than SUD; due to a general medical condition or dementia, delirium, schizophrenia, bipolar disorder, personality disorders, learning disability or any other condition to the extent that engagement in the intervention would not be possible, e.g. communication difficulties.
- Unlikely to be available for outcome assessments (temporary residence).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culturally Adapted Manually Assisted Problem-Solving Intervention (CMAP) Plus CBT Based Motivational Interviewing for Self-Harm in Individuals With Substance Use Disorder in Pakistan: A Feasibility RCT
Objectives:
To determine the feasibility and acceptability of the culturally adapted CMAP Plus CBT based Motivational Interviewing (MICBT) called CMAP Plus for self-harm in individuals with substance use disorder (SUD) in a feasibility randomised controlled trial.
Read more
To explore participants' experiences with CMAP Plus intervention.
Study design and setting:
The study will be a mixed-method feasibility randomised controlled trial of CMAP Plus as an intervention for Self-Harm in individuals with SUD in Pakistan. The study will be conducted in six major cities in Pakistan: Rawalpindi, Karachi, Peshawar, Hyderabad, Multan and Lahore.
Sample size:
A total of N=80 participants will be recruited from hospital settings and addiction rehabilitation centers in participating study sites.
Read the detailed description
The study aims to determine the feasibility and acceptability of culturally Adapted Manually Assisted problem-solving intervention (CMAP) Plus MICBT for self-harm in individuals with SUD. The intervention will include specific strategies to identify and address obstacles in changing self-harm and drug-taking behaviour and offer ways to manage these difficulties from a cognitive-behavioural formulation. The intervention will also include CBT based mindfulness practice that involves learning to purposefully pay attention to ones inner and external experiences with an impartial non judging attitude. It can enable people to change the way they think and feel about their experiences, especially stressful experiences. The study will recruit a total of 80 participants from participating study sites, and prospective participants will be screened against eligibility criteria. Eligible consented participants will then be enrolled in the study. An independent statistician will randomise participants to one of the two study arms: 1) CMAP Plus (Intervention) along with Treatment As Usual (TAU); or 2) TAU alone. Each participant in the intervention arm will receive 12 individual, weekly sessions. Each session will take approximately 50-60 minutes. The sessions will be delivered at a place convenient to the participants. Trained therapists will deliver the intervention. The TAU will be comprised of standard care they will be receiving from participating centres at recruitment sites. Assessment measures will be administered before and after the intervention at 12th week. All assessments will be rater blind. After post-assessments at 12th week, a purposefully selected subset (stratified by age, gender, ethnicity, sexuality, religion, clinical and recovery scores) of participants will be invited for qualitative interviews to explore their experiences and satisfaction with the intervention. Participants will be interviewed within 1 week of their post-intervention by a trained qualitative researcher exploring their experience with CMAP Plus, the barriers and facilitators to engagement, and perceived benefits or negative experiences with the intervention. A sample of up to 15 interviews would be enough to achieve category saturation. On average, interviews will last for 60 minutes. The interview will be face-to-face or through telephone as an alternative to a face-to-face meeting to reduce the number of in-person meetings given the current context of COVID-19.
- Conditions
- Self Harm, Substance-Related Disorders
- Being tested
- CMAP Plus
- Medical subject headings
- Self-Injurious Behavior, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMAP PlusBehavioural
The CMAP Plus intervention will be delivered individually, weekly over a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CMAP Plus | Experimental | CMAP Plus is comprised of an existing culturally adapted manually assisted problem-solving intervention (CMAP) integrated with CBT based Motivational Interviewing (MICBT) called (CMAP Plus). The TAU of intervention group participants will be continued along with study intervention. Receives: Behavioral: CMAP Plus |
| TAU alone | No intervention | This will be comprised of standard care they will be receiving from participating centres at recruitment sites. The standard care for individuals with SUD in Pakistan usually includes a 2-3-week detoxification programme, followed by 2 months of weekly 1:1 session along with some family sessions, followed by a period of support groups programmes. |
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 collecting data on recruitment rates. The success criterion of feasibility will be to recruit > 50% of eligible participants. We will also record attrition (number of dropouts) and retention rate (the proportion of participants who complete the intervention period).
Measured: From baseline to 12th week (at the end of intervention)
Acceptability indicator
The acceptability of intervention will be assessed using data on attendance. The criterion for acceptability is a mean attendance rate of >70% of sessions (at least 9 sessions).
Measured: From baseline to 12th week (at the end of intervention)
Secondary outcomes (7)
The deliberate self-harm inventory
The deliberate self-harm inventory is a 17-item, behaviorally based, a self- report questionnaire developed by the author to assess deliberate self-harm. This measure assesses various aspects of deliberate self-harm, including frequency, severity, duration, and type of self-harming behavior.
Measured: From baseline to 12th week (at the end of intervention)
Beck scale for suicide ideation
A 19-item instrument for detecting and measuring the current intensity of patient-specific attitude, behavior, and specificity of patient thoughts to kill him/ herself during the past week.
Measured: From baseline to 12th week (at the end of intervention)
Beck Hopelessness Scale
Beck hopelessness scale is to measure three aspects of hopelessness, feelings about the future, loss of motivation, and expectations to assess participants' feelings of hopelessness.
Measured: From baseline to 12th week (at the end of intervention)
Severity of dependence scale
Severity of dependence scale contains five items, all of which are explicitly concerned with psychological components of dependence. These items are specifically concerned with impaired control over drug-taking and with preoccupation and anxieties about drug use. It can be used to measure the degree of dependence experienced by users of different types of drugs.
Measured: From baseline to 12th week (at the end of intervention)
Depression Anxiety Stress Scale
Depression Anxiety Stress Scale is a set of three self-report scales designed to measure the negative emotional states of depression, anxiety, and stress and consists of 7 items per subscale.
Measured: From baseline to 12th week (at the 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 (at the end of intervention)
Client Service Receipt Inventory
Client Service Receipt Inventory will be used to get detailed description of the use of health services (including the informal sector faith healers/Imams) at 12th week follow up assessment.
Measured: From baseline to 12th week (at the 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 posted27 Jul 2022
- Study start1 Dec 2023
- Primary completion30 Jan 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nusrat Husain, Principal investigator, University of ManchesterNasim Chaudhry, Principal investigator, Pakistan Institute of Living and Learning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476601
- Sponsor's protocol ID
- SAHAR M-CMAP Plus-003
- Acronym
- CMAP Plus
- Status last verified
- May 2026
- First submitted
- 25 Jul 2022
- Last updated
- 27 May 2026
- 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 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Manually Assisted Problem-Solving Intervention (CMAP) Plus CBT Based Motivational Interviewing for Self-Harm in Individuals With Substance Use Disorder in Pakistan: A Feasibility RCT
- ClinicalTrials.gov ID
- NCT05476601
- Acronym / sponsor ID
- CMAP Plus / SAHAR M-CMAP Plus-003
- Conditions
- Self Harm, Substance-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 27 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.
Objectives:
To determine the feasibility and acceptability of the culturally adapted CMAP Plus CBT based Motivational Interviewing (MICBT) called CMAP Plus for self-harm in individuals with substance use disorder (SUD) in a feasibility randomised controlled trial.
To explore participants' experiences with CMAP Plus intervention.
Study design and setting:
The study will be a mixed-method feasibility randomised controlled trial of CMAP Plus as an intervention for Self-Harm in individuals with SUD in Pakistan. The study will be conducted in six major cities in Pakistan: Rawalpindi, Karachi, Peshawar, Hyderabad, Multan and Lahore.
Sample size:
A total of N=80 participants will be recruited from hospital settings and addiction rehabilitation centers in participating study sites.
Detailed description
The study aims to determine the feasibility and acceptability of culturally Adapted Manually Assisted problem-solving intervention (CMAP) Plus MICBT for self-harm in individuals with SUD. The intervention will include specific strategies to identify and address obstacles in changing self-harm and drug-taking behaviour and offer ways to manage these difficulties from a cognitive-behavioural formulation. The intervention will also include CBT based mindfulness practice that involves learning to purposefully pay attention to ones inner and external experiences with an impartial non judging attitude. It can enable people to change the way they think and feel about their experiences, especially stressful experiences. The study will recruit a total of 80 participants from participating study sites, and prospective participants will be screened against eligibility criteria. Eligible consented participants will then be enrolled in the study. An independent statistician will randomise participants to one of the two study arms: 1) CMAP Plus (Intervention) along with Treatment As Usual (TAU); or 2) TAU alone. Each participant in the intervention arm will receive 12 individual, weekly sessions. Each session will take approximately 50-60 minutes. The sessions will be delivered at a place convenient to the participants. Trained therapists will deliver the intervention. The TAU will be comprised of standard care they will be receiving from participating centres at recruitment sites. Assessment measures will be administered before and after the intervention at 12th week. All assessments will be rater blind. After post-assessments at 12th week, a purposefully selected subset (stratified by age, gender, ethnicity, sexuality, religion, clinical and recovery scores) of participants will be invited for qualitative interviews to explore their experiences and satisfaction with the intervention. Participants will be interviewed within 1 week of their post-intervention by a trained qualitative researcher exploring their experience with CMAP Plus, the barriers and facilitators to engagement, and perceived benefits or negative experiences with the intervention. A sample of up to 15 interviews would be enough to achieve category saturation. On average, interviews will last for 60 minutes. The interview will be face-to-face or through telephone as an alternative to a face-to-face meeting to reduce the number of in-person meetings given the current context of COVID-19.
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 | Experimental | Behavioral: CMAP PlusCMAP Plus is comprised of an existing culturally adapted manually assisted problem-solving intervention (CMAP) integrated with CBT based Motivational Interviewing (MICBT) called (CMAP Plus). The TAU of intervention group participants will be continued along with study intervention. |
| TAU alone | No intervention | –This will be comprised of standard care they will be receiving from participating centres at recruitment sites. The standard care for individuals with SUD in Pakistan usually includes a 2-3-week detoxification programme, followed by 2 months of weekly 1:1 session along with some family sessions, followed by a period of support groups programmes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 and above.
- Individuals diagnosed with SUD on DSM-5 criteria of mental disorders.
- Having episodes of self-harm in last three months defined as a deliberate act to harm one's own body including but not limited to self-cutting, self-biting, self-poisoning, self-scratching, self-burning, self-hitting, pulling hair etc. assessed by deliberate self-harm inventory.
- Capable to give informed consent.
- Those who have completed detoxification process.
Key exclusion criteria (2 listed)
- Participants with DSM-5 criteria of mental disorder other than SUD; due to a general medical condition or dementia, delirium, schizophrenia, bipolar disorder, personality disorders, learning disability or any other condition to the extent that engagement in the intervention would not be possible, e.g. communication difficulties.
- 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 PlusThe CMAP Plus intervention will be delivered individually, weekly over a period of 12 weeks. | Behavioural | CMAP Plus |
Primary outcome
Feasibility Indicator
Time frame: From baseline to 12th week (at the end of intervention)
The feasibility will be determined by collecting data on recruitment rates. The success criterion of feasibility will be to recruit > 50% of eligible participants. We will also record attrition (number of dropouts) and retention rate (the proportion of participants who complete the intervention period).
Acceptability indicator
Time frame: From baseline to 12th week (at the end of intervention)
The acceptability of intervention will be assessed using data on attendance. The criterion for acceptability is a mean attendance rate of >70% of sessions (at least 9 sessions).
7 secondary outcomes
The deliberate self-harm inventory
Time frame: From baseline to 12th week (at the end of intervention)
Beck scale for suicide ideation
Time frame: From baseline to 12th week (at the end of intervention)
Beck Hopelessness Scale
Time frame: From baseline to 12th week (at the end of intervention)
Severity of dependence scale
Time frame: From baseline to 12th week (at the end of intervention)
Depression Anxiety Stress Scale
Time frame: From baseline to 12th week (at the end of intervention)
Euro-Qol-5 Dimensions scale
Time frame: From baseline to 12th week (at the end of intervention)
Client Service Receipt Inventory
Time frame: From baseline to 12th week (at the end of intervention)
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 27 May 2026.
- Individual participant dataSharing planned: No
Related trials for Self Harm
RecruitingObservational study
Friends/Family of Individuals at Risk of Suicide Training Program
Caregiver, Caregiver Mental Health
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
RecruitingObservational study
Evaluation of National Highly Specialized Care for Children and Adolescents With Severe Self-Harm or Eating Disorders
Self-harm Behavior, Eating Disorders
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 Husain principal investigator
University of Manchester
Nasim Chaudhry principal investigator
Pakistan Institute of Living and Learning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMAP Plus in people with Self Harm and Substance-Related Disorders, 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: finished, as of the sponsor's last update on 27 May 2026. 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?
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?
Feasibility Indicator (time frame: From baseline to 12th week (at the 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 27 May 2026.