An assessment of the effectiveness of Psychodynamic Interpersonal Therapy in reducing the repetition of self-harm in adults presenting to an emergency department with acute self-harm (history of 3 or fewer episodes in the last 12 months)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2021
INTERVENTION: The SafePIT RCT is a 1:1 randomised controlled trial of standard care plus referral to intervention vs standard care alone. A total of 770 participants will be recruited across 12 sites (Mental Health Trusts) following attendance at a hospital ED. To ensure that our intervention is compatible with NHS practice we will recruit through mechanisms which mirror NHS pathways. Patients who potentially meet the eligibility criteria will be verbally informed of the study (by the clinical care team) and given a copy of the Participant Information Sheet, and will be asked for their permission for researcher contact. If they agree to this contact, they will be asked to provide their contact details which will be sent to the local researcher via secure email (or the local researcher will collect). They will not be asked to consent to any study procedures or study involvement at this stage. Consent to researcher contact may be given either in writing or verbally by the participant. Verbal consent to contact will be recorded on the designated ‘consent to contact’ form by the clinical care team. If the potential participant leaves hospital prior to the psychosocial assessment having taken place, and local procedure is for the clinician to contact them by telephone to arrange the assessment, they may introduce the study to the potential participant and take verbal consent to researcher contact during such a clinically indicated telephone contact. The participant information sheet with a covering invitation letter will then be sent to them via post or email. Following consent to researcher contact (C2C) and clinical screening the local researcher will contact the potential participant to further discuss t CONDITION: Self harm ; Mental and Behavioural Disorders PRIMARY OUTCOME: Time (in months) from randomisation to first repetition of self‐harm leading to hospital attendance, obtained from HES data supplemented by clinical record check. INCLUSION CRITERIA: 1. Aged 18 years or over 2. Registered with a GP in the catchment area of the mental health trust for the duration of the therapy 3. Presenting at ED as a consequence of self‐harm, defined as: intentional acts that directly harm a person's own body. This includes methods like cutting, burning, scratching, banging or hitting parts of the body, or interfering with wound healing and it also includes self‐poisoning, such as taking overdoses of drugs. 4. Self‐harmed 1‐2 times in the last 12 months (any amount in their lifetime) OR self‐harmed exactly 3 times in the last 12 months but never before this year. 5. Mental capacity to provide fully informed written consent SECONDARY OUTCOME: ; 1. Rate of repetition of self‐harm leading to hospital attendance at 6 and 12 months, obtained from HES data supplemented by clinical record check.; 2. Time (in months) from randomisation to repetition of self‐harm leading to hospital attendance (all events), obtained from HES data supplemented by clinical record check.; 3. Rate of repetition of self‐reported self‐harm at 6 and 12 months, obtained via monthly text message and 6 and 12‐month questionnaires.; 4. Psychological distress as measured by (CORE‐OM) at 6 and 12 months.; 5. The proportion of people with clinically significant improvement (and deterioration) on CORE‐OM at 6 and 12 months.; 6. Anxiety as measured by the Generalised Anxiety Disorder‐7 (GAD‐7) at 6 and 12 months.; 7. Hopelessness as measured by the Beck Hopelessness Scale (BHS) at 6 and 12 months.; 8. Interpersonal function measured by the Inventory of Interpersonal Problems (IIP‐32) at 6 and 12 months.; 9. Quality of life as measured by the ReQoL‐10 at 6 and 12 months (with comparison to EQ‐5D‐5L and CORE‐6D measures).; 10. Health care use, measured by a structured health‐resource–use questionnaire and HES data, over 12 months post‐randomisation.; 11. QALYs based on ReQOL at 6 and 12 months.; ; Internal Pilot Outcome Measure:; 1. Recruitment and intervention delivery at 12 months.; ; Qualitative Evaluation Outcome Measures:; 1. Thematic analysis of interviews of participants and/or their supporters regarding experience of receiving the therapy.; 2. Thematic analysis of interviews of the therapists’ experience of participating in the trial.; 3. Logic model of interviews of the service managers and therapists of how the intervention was delivered and the implications for sustaining the intervention in future.;
Epistemonikos ID: 8d19411f84e891839b7adc79c612b81c12bc8440
First added on: Aug 25, 2024