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

NCT05476601 | Recruiting DMC

• 1 other identifier: SAHAR M-CMAP Plus-003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Self Harm; Substance-Related Disorders

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (7)

• The deliberate self-harm inventory

  From baseline to 12th week (at the end of intervention)

• Beck scale for suicide ideation

  From baseline to 12th week (at the end of intervention)

• Beck Hopelessness Scale

  From baseline to 12th week (at the end of intervention)

• Severity of dependence scale

  From baseline to 12th week (at the end of intervention)

• Depression Anxiety Stress Scale

  From baseline to 12th week (at the end of intervention)

Study Arms (2)

CMAP Plus

EXPERIMENTAL

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.

Behavioral: CMAP Plus

TAU alone

NO 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.

Interventions

CMAP Plus BEHAVIORAL

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

CMAP Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pakistan Institute of Living and Learning: lead

Study Sites (1)

Pakistan Recovery Oasis

Lahore, Pakistan

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Nusrat Husain

  University of Manchester

  PRINCIPAL INVESTIGATOR

• Nasim Chaudhry

  Pakistan Institute of Living and Learning

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUQADDAS ASIF

CONTACT

03364057787; muqaddasasif@pill.org.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: December 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)