Clinical trial NCT05476601: CMAP Plus Intervention for Self-harm in Individuals with Substance Use Disorder in Pakistan
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
Overall status: RECRUITING
Phase: NA
Conditions: Self Harm
Substance-Related Disorders
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2022-07-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Feasibility Indicator
timeFrame: From baseline to 12th week (at the end of intervention)
measure: Acceptability indicator
timeFrame: From baseline to 12th week (at the end of intervention)
Secondary outcomes:
measure: The deliberate self-harm inventory
timeFrame: From baseline to 12th week (at the end of intervention)
measure: Beck scale for suicide ideation
timeFrame: From baseline to 12th week (at the end of intervention)
measure: Beck Hopelessness Scale
timeFrame: From baseline to 12th week (at the end of intervention)
measure: Severity of dependence scale
timeFrame: From baseline to 12th week (at the end of intervention)
measure: Depression Anxiety Stress Scale
timeFrame: From baseline to 12th week (at the end of intervention)
measure: Euro-Qol-5 Dimensions scale
timeFrame: From baseline to 12th week (at the end of intervention)
measure: Client Service Receipt Inventory
timeFrame: From baseline to 12th week (at the end of intervention)
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Recovery Oasis
Study officials:
affiliation: University of Manchester
name: Nusrat Husain
role: PRINCIPAL_INVESTIGATOR
affiliation: Pakistan Institute of Living and Learning
name: Nasim Chaudhry
role: PRINCIPAL_INVESTIGATOR
References: