PEPS Data Linkage Study

• Research type

  Research Study

• Full title

  Psychoeducation with problem solving (PEPS) therapy for adults with personality disorder: A data linkage study to clarify safety and service use among trial participants

• IRAS ID

  172593

• Contact name

  Mary McMurran

• Contact email

  mary.mcmurran@nottingham.ac.uk

• Sponsor organisation

  University of Nottingham

• Duration of Study in the UK

  0 years, 3 months, 2 days

• Research summary

  A randomised controlled trial of psycho-education and problem solving (PEPS) therapy for adults with personality disorder was completed in October 2014. Recruitment to the trial had been stopped prematurely because more adverse events were reported in the group receiving PEPS therapy. At the end of the trial the results showed that PEPS therapy was not effective. In addition analysis showed a tendency for PEPS participants to experience more adverse events although the results were inconclusive because of potential bias in identifying adverse events, in that there was greater follow-up in the treatment arm, and a possible difference in reporting procedures between arms.
  The purpose of this study is to clarify safety and service use among participants in the PEPS trial. The study will evaluate the safety of PEPS therapy compared with treatment as usual with respect to hospital admissions, emergency department attendances and deaths occurring in trial participants during the trial treatment and follow-up period. Data will be sought from the Health and Social Care Information Centre (HSCIC). Access to this centrally held data is important to ensure maximum objectivity and reliability. Eligible participants are those who provided consent to take part in the PEPS Study and were randomised. Participants who withdrew consent to participate in the PEPS trial will not be included in the current study. This study will provide knowledge for clinicians to help them avoid applying treatments in ways that may cause harm.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  15/EM/0471

• Date of REC Opinion

  3 Nov 2015

• REC opinion

  Favourable Opinion