title: Comparing the clinical-effectiveness and cost-effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive-behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain.
  
  
  METHODS
  Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial.
  
  
  BACKGROUND
  The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals.
  
  
  BACKGROUND
  ISRCTN18166896.
authors.affiliation: Department of Clinical Therapies, Faculty of Education and Health Sciences, University of Limerick, Limerick, Ireland.
authors.forename: Sara
authors.initials: S
authors.lastname: Hayes
authors.affiliation: School of Psychology, National University of Ireland, Galway, Ireland.
authors.forename: Michael
authors.initials: M
authors.lastname: Hogan
authors.affiliation: Centre for Pain Research, National University of Ireland, Galway, Ireland.
authors.forename: Haulie
authors.initials: H
authors.lastname: Dowd
authors.affiliation: Discipline of Economics, National University of Ireland, Galway, Ireland.
authors.forename: Edel
authors.initials: E
authors.lastname: Doherty
authors.affiliation: Centre for Pain Research, National University of Ireland, Galway, Ireland.
authors.forename: Siobhan
authors.initials: S
authors.lastname: O'Higgins
authors.affiliation: Discipline of Health Promotion, National University of Ireland, Galway, Ireland.
authors.forename: Saoirse
authors.initials: S
authors.lastname: Nic Gabhainn
authors.affiliation: School of Psychology, National University of Ireland, Galway, Ireland.
authors.forename: Padraig
authors.initials: P
authors.lastname: MacNeela
authors.affiliation: Discipline of General Practice, National University of Ireland, Galway, Ireland.
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Murphy
authors.affiliation: Discipline of Medical Informatics and Education, National University of Ireland, Galway, Ireland.
authors.forename: Thomas
authors.initials: T
authors.lastname: Kropmans
authors.affiliation: Discipline of Economics, National University of Ireland, Galway, Ireland.
authors.forename: Ciaran
authors.initials: C
authors.lastname: O'Neill
authors.affiliation: HRB Clinical Research Facility and School of Mathematics, Statistics and Applied Mathematics, National University of Ireland, Galway, Ireland.
authors.forename: John
authors.initials: J
authors.lastname: Newell
authors.affiliation: School of Psychology and Centre for Pain Research, National University of Ireland, Galway, Ireland.
authors.forename: Brian E
authors.initials: BE
authors.lastname: McGuire
mesh_terms: D064869:Acceptance and Commitment Therapy / Q000191:economics* / Q000379:methods*; D000328:Adult; D059350:Chronic Pain / Q000628:therapy*; D003362:Cost-Benefit Analysis; D006801:Humans; D020407:Internet; D012107:Research Design; D016037:Single-Blind Method; D016896:Treatment Outcome; D014850:Waiting Lists
keywords: Pain Management