Substance-Related Disorders Clinical Trial
— CMAP PlusOfficial 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. 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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Pakistan Institute of Living and Learning |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | From baseline to 12th week (at the end of intervention) | |
Primary | 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). | From baseline to 12th week (at the end of intervention) | |
Secondary | 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. | From baseline to 12th week (at the end of intervention) | |
Secondary | 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. | From baseline to 12th week (at the end of intervention) | |
Secondary | 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. | From baseline to 12th week (at the end of intervention) | |
Secondary | 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. | From baseline to 12th week (at the end of intervention) | |
Secondary | 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. | From baseline to 12th week (at the end of intervention) | |
Secondary | 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) | From baseline to 12th week (at the end of intervention) | |
Secondary | 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. | From baseline to 12th week (at the end of intervention) |
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