Study procedure
self-harm
RECRUITMENT
All procedures contributing to this work comply with the Helsinki Declaration of 1975, as revised in 2008. The study was approved by the Research Ethics Committee of the Karachi Medical and Dental College (027/15) and the University of Manchester (2019–2610-10693). The study's clinical trial registration number is NCT02742922 — registered with ClinicalTrials.gov.All patients presenting to the participating sites following an episode of self-harm were approached for recruitment. Detailed information about the research along with a Participant Information Leaflet was given to the potential participants. Potential participants were assessed by trained researchers against study eligibility criteria. Handwritten signatures (or thumbprints) were used to obtain informed consent from eligible participants. A trained researcher scheduled time with consented participants and baseline assessments were completed face to face either at a research office or the participant’s home. Following baseline assessments, a unique identification number (ID) was assigned to each participant and a list of IDs with details on age, gender, method of self-harm and study site was prepared by the trial manager and sent for randomisation. All the participants were made aware of their respective treatment arm within 1 week of randomisation. Participants in the intervention arm were contacted by the therapist to arrange the first session. All intervention sessions were delivered face to face either at a research office or the participant’s home, at a time convenient for both the therapist and participant. Follow-up assessments with participants from both study arms were carried out at 3-, 6-, 9-, and 12-month post-randomisation. All follow-up assessments were carried out face to face either at a research office or the participant’s home.