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CMAP Plus Intervention for Self-harm in Individuals With Substance Use Disorder in Pakistan (CMAP Plus)

Primary Purpose

Self Harm, Substance-Related Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CMAP Plus
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self Harm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CMAP Plus

    TAU alone

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).
    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).

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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)
    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.

    Full Information

    First Posted
    July 25, 2022
    Last Updated
    August 5, 2023
    Sponsor
    Pakistan Institute of Living and Learning
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05476601
    Brief Title
    CMAP Plus Intervention for Self-harm in Individuals With Substance Use Disorder in Pakistan
    Acronym
    CMAP Plus
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pakistan Institute of Living and Learning

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Self Harm, Substance-Related Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CMAP Plus
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    TAU alone
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CMAP Plus
    Intervention Description
    The CMAP Plus intervention will be delivered individually, weekly over a period of 12 weeks.
    Primary Outcome Measure Information:
    Title
    Feasibility Indicator
    Description
    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).
    Time Frame
    From baseline to 12th week (at the end of intervention)
    Title
    Acceptability indicator
    Description
    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).
    Time Frame
    From baseline to 12th week (at the end of intervention)
    Secondary Outcome Measure Information:
    Title
    The deliberate self-harm inventory
    Description
    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.
    Time Frame
    From baseline to 12th week (at the end of intervention)
    Title
    Beck scale for suicide ideation
    Description
    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.
    Time Frame
    From baseline to 12th week (at the end of intervention)
    Title
    Beck Hopelessness Scale
    Description
    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.
    Time Frame
    From baseline to 12th week (at the end of intervention)
    Title
    Severity of dependence scale
    Description
    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.
    Time Frame
    From baseline to 12th week (at the end of intervention)
    Title
    Depression Anxiety Stress Scale
    Description
    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.
    Time Frame
    From baseline to 12th week (at the end of intervention)
    Title
    Euro-Qol-5 Dimensions scale
    Description
    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)
    Time Frame
    From baseline to 12th week (at the end of intervention)
    Title
    Client Service Receipt Inventory
    Description
    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.
    Time Frame
    From baseline to 12th week (at the end of intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MUQADDAS ASIF
    Phone
    03364057787
    Email
    muqaddasasif@pill.org.pk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nusrat Husain
    Organizational Affiliation
    University of Manchester
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Nasim Chaudhry
    Organizational Affiliation
    Pakistan Institute of Living and Learning
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    CMAP Plus Intervention for Self-harm in Individuals With Substance Use Disorder in Pakistan

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