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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
The CMAP Plus intervention will be delivered individually, weekly over a period of 12 weeks.
Pakistan Recovery Oasis
Lahore, Pakistan
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).
Time frame: 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).
Time frame: From baseline to 12th week (at the end of intervention)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: From baseline to 12th week (at the end of intervention)
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