title: Problem Management Plus (PM+) for common mental disorders in a humanitarian setting in Pakistan; study protocol for a randomised controlled trial (RCT).
abstract: BACKGROUND
  In humanitarian settings common mental disorders (depression, anxiety disorders, posttraumatic stress disorder) are highly prevalent. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a 5-session, individual psychological intervention program, delivered by paraprofessionals that addresses common mental disorders in people in communities affected by adversity. The objectives of this study are to test effectiveness and cost-effectiveness of the locally adapted PM+ compared to Treatment as usual (TAU) in Peshawar District, Pakistan.
  
  
  METHODS
  A randomised controlled trial will be conducted in 346 primary care attendees in 3 health care centres in Peshawar District, Pakistan. After informed consent, primary care attendees with high levels of psychological distress according to the General Health Questionnaire-12 (GHQ-12) and functional impairment (WHO Disability Assessment Schedule 2.0 (WHODAS)) will be assigned to PM+ (n = 173) or TAU (n = 173). At baseline, 1 week and 3 months following PM+, independent assessors will assess psychological distress with the Hospital Anxiety and Depression Scale (HADS), and functional disability with the WHODAS. Secondary outcomes are posttraumatic stress disorder (PTSD) symptoms, and client-perceived priority problems. Further, cost-effectiveness will be assessed using the Service Receipt Inventory (SRI).
  
  
  CONCLUSIONS
  If proven effective, PM+ will be rolled out to other areas for further adaptation and testing in diverse humanitarian settings.
  
  
  BACKGROUND
  ACTRN12614001235695. Registered 26 November 2014. Australian New Zealand Clinical Trials Registry.
authors.affiliation: Department of Clinical Psychology, VU University Amsterdam and EMGO Institute for Health and Care Research, Amsterdam, The Netherlands. e.m.sijbrandij@vu.nl.
authors.forename: Marit
authors.initials: M
authors.lastname: Sijbrandij
authors.affiliation: Post Graduate Medical Institute, Lady Reading Hospital, Peshawar, Pakistan. sfarooqlrh@yahoo.com.
authors.forename: Saeed
authors.initials: S
authors.lastname: Farooq
authors.affiliation: School of Psychology, University of New South Wales, Sydney, Australia. r.bryant@unsw.edu.au.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Bryant
authors.affiliation: School of Psychology, University of New South Wales, Sydney, Australia. k.dawson@unsw.edu.au.
authors.forename: Katie
authors.initials: K
authors.lastname: Dawson
authors.affiliation: University of Liverpool and Human Development Research Foundation, Islamabad, Pakistan. s.u.hamdani@liverpool.ac.uk.
authors.forename: Syed Usman
authors.initials: SU
authors.lastname: Hamdani
authors.affiliation: University of Liverpool and Human Development Research Foundation, Islamabad, Pakistan. anna.chiumento@liverpool.ac.uk.
authors.forename: Anna
authors.initials: A
authors.lastname: Chiumento
authors.affiliation: WHO Collaborating Centre for Mental Health Research, Training and Substance Abuse and Institute of Psychiatry, Rawalpindi Medical College, University of Health Sciences, Rawalpindi, Pakistan. minhas.fa@gmail.com.
authors.forename: Fareed
authors.initials: F
authors.lastname: Minhas
authors.affiliation: WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt. saeedk@who.int.
authors.forename: Khalid
authors.initials: K
authors.lastname: Saeed
authors.affiliation: University of Liverpool and Human Development Research Foundation, Islamabad, Pakistan. atif.rahman@liverpool.ac.uk.
authors.forename: Atif
authors.initials: A
authors.lastname: Rahman
authors.affiliation: Department of Mental Health and Substance Abuse, World Health Organization (WHO), Geneva, Switzerland. vanommerenm@who.int.
authors.forename: Mark
authors.initials: M
authors.lastname: van Ommeren
mesh_terms: D000293:Adolescent; D000328:Adult; D000533:Altruism; D001008:Anxiety Disorders / Q000191:economics / Q000209:etiology; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000191:economics; D003866:Depressive Disorder / Q000191:economics / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D010154:Pakistan; D011320:Primary Health Care / Q000191:economics; D011613:Psychotherapy / Q000191:economics / Q000379:methods*; D013313:Stress Disorders, Post-Traumatic / Q000191:economics / Q000209:etiology; D013315:Stress, Psychological / Q000191:economics / Q000628:therapy*