title: The PROblem Gambling RESearch Study (PROGRESS) research protocol: a pragmatic randomised controlled trial of psychological interventions for problem gambling.
abstract: BACKGROUND
  International prevalence rates for problem gambling are estimated at 2.3%. Problem gambling is a serious global public health concern due to adverse personal and social consequences. Previous research evaluating the effectiveness of psychological interventions for the treatment of problem gambling has been compromised by methodological limitations, including small sample sizes and the use of waitlist control groups. This article describes the study protocol for a pragmatic randomised controlled trial (RCT) evaluating the effectiveness of cognitive-behavioural therapy (CBT), behaviour therapy (BT), motivational interviewing (MI) against a non-directive supportive therapy (NDST) control, in treating problem gambling.
  
  
  METHODS
  This study was a mixed-methods design, with a parallel group, pragmatic RCT as the primary component, and embedded qualitative studies conducted alongside. A total of 297 participants were recruited from the community in Victoria, Australia. Individuals aged 18 years and over, could communicate in English and wished to receive treatment for a gambling problem were eligible. Participants were randomly allocated in to 1 of the 4 psychological interventions: CBT, BT, MI and NDST. Repeated measures were conducted at pretreatment and post-treatment, and 6 and 12 months post-treatment. The statistical analysis will use an intention-to-treat approach. Multilevel mixed modelling will be used to examine changes in the primary outcome measures: gambling symptom severity, using the Gambling Symptom Assessment Scale, and gambling behaviours (frequency, time and expenditure). Secondary outcomes are depression, anxiety, stress and alcohol use. Individual semistructured qualitative interviews were conducted at pretreatment and post-treatment and 12 months post-treatment for a subset of participants (n=66).
  
  
  BACKGROUND
  This study was approved by the Victorian Department of Justice, Monash University and the University of Melbourne Human Research Ethics Committees. Findings will be reported in a government report, peer-reviewed publications and conference presentations.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN01629698.
authors.affiliation: Primary Care Research Unit, School of Primary Health Care, Monash University, Notting Hill, Victoria, Australia.
authors.forename: Shane A
authors.initials: SA
authors.lastname: Thomas
authors.affiliation: Primary Care Research Unit, School of Primary Health Care, Monash University, Notting Hill, Victoria, Australia.
authors.forename: Stephanie S
authors.initials: SS
authors.lastname: Merkouris
authors.affiliation: Primary Care Research Unit, School of Primary Health Care, Monash University, Notting Hill, Victoria, Australia RDNS Institute, St Kilda, Victoria, Australia.
authors.forename: Colette J
authors.initials: CJ
authors.lastname: Browning
authors.affiliation: Primary Care Research Unit, School of Primary Health Care, Monash University, Notting Hill, Victoria, Australia.
authors.forename: Harriet
authors.initials: H
authors.lastname: Radermacher
authors.affiliation: Primary Care Research Unit, School of Primary Health Care, Monash University, Notting Hill, Victoria, Australia.
authors.forename: Susan
authors.initials: S
authors.lastname: Feldman
authors.affiliation: Primary Care Research Unit, School of Primary Health Care, Monash University, Notting Hill, Victoria, Australia.
authors.forename: Joanne
authors.initials: J
authors.lastname: Enticott
authors.affiliation: Melbourne Graduate School of Education, University of Melbourne, Carlton, Victoria, Australia Heart Research Centre, North Melbourne, Victoria, Australia.
authors.forename: Alun C
authors.initials: AC
authors.lastname: Jackson
mesh_terms: D000328:Adult; D000428:Alcohol Drinking; D001007:Anxiety / Q000628:therapy; D001008:Anxiety Disorders / Q000628:therapy; D016739:Behavior, Addictive / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003362:Cost-Benefit Analysis; D003863:Depression / Q000628:therapy; D003866:Depressive Disorder / Q000628:therapy; D005260:Female; D005715:Gambling / Q000523:psychology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D062405:Motivational Interviewing; D012107:Research Design; D012720:Severity of Illness Index
keywords: MENTAL HEALTH; PRIMARY CARE; PUBLIC HEALTH