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

NCT ID: NCT05476601

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2025-06-30

Brief Summary

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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

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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

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Self Harm Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CMAP Plus

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.

Group Type EXPERIMENTAL

CMAP Plus

Intervention Type BEHAVIORAL

The CMAP Plus intervention will be delivered individually, weekly over a period of 12 weeks.

TAU alone

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CMAP Plus

The CMAP Plus intervention will be delivered individually, weekly over a period of 12 weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pakistan Institute of Living and Learning

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nusrat Husain

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Nasim Chaudhry

Role: PRINCIPAL_INVESTIGATOR

Pakistan Institute of Living and Learning

Locations

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Pakistan Recovery Oasis

Lahore, , Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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MUQADDAS ASIF

Role: CONTACT

Phone: 03364057787

Email: [email protected]

Facility Contacts

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Junaid

Role: primary

Other Identifiers

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SAHAR M-CMAP Plus-003

Identifier Type: -

Identifier Source: org_study_id