title: Te Ira Tangata: a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in Maori who present to hospital after self harm.
abstract: BACKGROUND
  Maori, the indigenous people of New Zealand, who present to hospital after intentionally harming themselves, do so at a higher rate than non-Maori. There have been no previous treatment trials in Maori who self harm and previous reviews of interventions in other populations have been inconclusive as existing trials have been under powered and done on unrepresentative populations. These reviews have however indicated that problem solving therapy and sending regular postcards after the self harm attempt may be an effective treatment. There is also a small literature on sense of belonging in self harm and the importance of culture. This protocol describes a pragmatic trial of a package of measures which include problem solving therapy, postcards, patient support, cultural assessment, improved access to primary care and a risk management strategy in Maori who present to hospital after self harm using a novel design.
  
  
  METHODS
  We propose to use a double consent Zelen design where participants are randomised prior to giving consent to enrol a representative cohort of patients. The main outcome will be the number of Maori scoring below nine on the Beck Hopelessness Scale. Secondary outcomes will be hospital repetition at one year; self reported self harm; anxiety; depression; quality of life; social function; and hospital use at three months and one year.
  
  
  CONCLUSIONS
  A strength of the study is that it is a pragmatic trial which aims to recruit Maori using a Maori clinical team and protocol. It does not exclude people if English is not their first language. A potential limitation is the analysis of the results which is complex and may underestimate any effect if a large number of people refuse their consent in the group randomised to problem solving therapy as they will effectively cross over to the treatment as usual group. This study is the first randomised control trial to explicitly use cultural assessment and management.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000952246.
authors.affiliation: Department of Psychological Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Private bag 92019, Auckland, New Zealand. s.hatcher@auckland.ac.nz
authors.forename: Simon
authors.initials: S
authors.lastname: Hatcher
authors.forename: Nicole
authors.initials: N
authors.lastname: Coupe
authors.forename: Mason
authors.initials: M
authors.lastname: Durie
authors.forename: Hinemoa
authors.initials: H
authors.lastname: Elder
authors.forename: Rees
authors.initials: R
authors.lastname: Tapsell
authors.forename: Karen
authors.initials: K
authors.lastname: Wikiriwhi
authors.forename: Varsha
authors.initials: V
authors.lastname: Parag
mesh_terms: D001007:Anxiety / Q000208:ethnology / Q000523:psychology; D015709:Correspondence as Topic; D003466:Cultural Characteristics; D003863:Depression / Q000208:ethnology / Q000523:psychology; D058006:General Practice; D006297:Health Services Accessibility; D006760:Hospitalization; D006801:Humans; D009520:New Zealand / Q000208:ethnology; D010359:Patient Readmission; D011340:Problem Solving; D011569:Psychiatric Status Rating Scales; D011614:Psychotherapy, Brief; D011788:Quality of Life; D012107:Research Design; D040242:Risk Reduction Behavior; D016728:Self-Injurious Behavior / Q000175:diagnosis / Q000208:ethnology / Q000523:psychology / Q000628:therapy*; D012919:Social Behavior; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome