NCT05476601 CMAP Plus Intervention for Self-harm in Individuals with Substance Use Disorder in Pakistan
| NCT ID | NCT05476601 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pakistan Institute of Living and Learning |
| Condition | Self Harm |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2025-04 |
Trial Parameters
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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.
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).