title: Design considerations of a randomized clinical trial on a cognitive behavioural intervention using communication and information technologies for managing chronic low back pain.
abstract: BACKGROUND
  Psychological treatments have been successful in treating chronic low back pain (CLBP). However, the effect sizes are still modest and there is room for improvement. A way to progress is by enhancing treatment adherence and self-management using information and communication technologies (ICTs). Therefore, the objective of this study was to design a trial investigating the short- and long-term efficacy of cognitive behavioural treatment (CBT) for CLBP using or not ICTs. A secondary objective of this trial will be to evaluate the influence of relevant variables on treatment response. Possible barriers in the implementation of CBT with and without ICT will also be investigated.
  
  
  METHODS
  A randomised controlled trial with 180 CLBP patients recruited from specialised care will be conducted. Participants will be randomly assigned to three conditions: Control group (CG), CBT, and CBT supported by ICTs (CBT + ICT). Participants belonging to the three conditions will receive a conventional rehabilitation program (back school). The CBT group program will last six sessions. The CBT + ICT group will use the internet and SMS to practice the therapeutic strategies between sessions and in the follow-ups at their homes. Primary outcome variables will be self-reported disability and pain intensity. Assessment will be carried out by blinded assessors in five moments: pre-treatment, post-treatment and 3-, 6-, and 12-month follow-ups. The influence of catastrophizing, fear-avoidance beliefs, anxiety and depression in response to treatment in the primary outcomes will also be analysed.
  
  
  CONCLUSIONS
  This study will show data of the possible benefits of using ICTs in the improvement of CBT for treating CLBP.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT01802671.
authors.affiliation: Orthopaedic Surgery Department, Hospital Arnau de Vilanova, C/ San Clemente, 46015, Valencia, Spain. julio.domenech@uch.ceu.es
authors.forename: Julio
authors.initials: J
authors.lastname: Domenech
authors.forename: Rosa
authors.initials: R
authors.lastname: Baños
authors.forename: Lourdes
authors.initials: L
authors.lastname: Peñalver
authors.forename: Azucena
authors.initials: A
authors.lastname: Garcia-Palacios
authors.forename: Rocio
authors.initials: R
authors.lastname: Herrero
authors.forename: Aida
authors.initials: A
authors.lastname: Ezzedine
authors.forename: Monica
authors.initials: M
authors.lastname: Martinez-Diaz
authors.forename: Javier
authors.initials: J
authors.lastname: Ballester
authors.forename: Jaime
authors.initials: J
authors.lastname: Horta
authors.forename: Cristina
authors.initials: C
authors.lastname: Botella
mesh_terms: D001294:Attitude to Health; D058443:Catastrophization; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003142:Communication; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000523:psychology / Q000628:therapy*; D008297:Male; D008490:Medical Informatics / Q000379:methods* / Q000458:organization & administration; D059408:Pain Management / Q000379:methods*; D010349:Patient Compliance; D012107:Research Design; D013030:Spain