title: Evaluation and implementation of graded in vivo exposure for chronic low back pain in a German outpatient setting: a study protocol of a randomized controlled trial.
abstract: BACKGROUND
  The purpose of the present study is to introduce an adapted protocol of in vivo exposure for fear avoidant back pain patients and its implementation in the German health care system without multidisciplinary teams. Case studies demonstrated promising effects but three preceding randomized controlled trials (RCTs) could not support the former results. More empirical support is necessary to further substantiate the effectiveness of in vivo exposure.
  
  
  METHODS
  A total of 108 chronic low back pain patients are randomly assigned to one out of three conditions (A: exposure_long (15 sessions), B: exposure_short (10 sessions) or C: control condition cognitive behavioral therapy (15 sessions)). The inclusion criteria are: back pain ≥3 months and a sufficient level of fear-avoidance. An effect evaluation, a process evaluation and an economic evaluation are conducted. Primary outcomes are pain-related disability and pain intensity. Secondary outcomes are: emotional distress, fear avoidance, catastrophizing and costs. Data are collected at baseline, upon completion of the intervention, after 10 sessions, and at six months following completion of treatment. Besides the comparison of exposure in vivo and cognitive behavioral therapy (CBT), we additionally compare a short and a long version of exposure to analyze dose response effects.
  
  
  CONCLUSIONS
  This is, to our knowledge, the first RCT comparing in vivo exposure to psychological treatment as usual in terms of cognitive behavioral therapy. Results will help to find out whether a tailored treatment for fear avoidant back pain patients is more effective than a general pain management treatment.
  
  
  BACKGROUND
  The trial has been registered to ClinicalTrial.gov. The trial registration number is NCT01484418.
authors.affiliation: Department for Clinical Psychology, Psychotherapy University of Marburg, Marburg, Germany.
authors.forename: Jenny
authors.initials: J
authors.lastname: Riecke
authors.forename: Sebastian
authors.initials: S
authors.lastname: Holzapfel
authors.forename: Winfried
authors.initials: W
authors.lastname: Rief
authors.forename: Julia Anna
authors.initials: JA
authors.lastname: Glombiewski
mesh_terms: D000553:Ambulatory Care / Q000191:economics; D001362:Avoidance Learning; D058443:Catastrophization; D059350:Chronic Pain / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003365:Costs and Cost Analysis; D004185:Disability Evaluation; D004644:Emotions; D005239:Fear; D005858:Germany; D017048:Health Care Costs; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000191:economics / Q000523:psychology / Q000628:therapy*; D010147:Pain Measurement; D011237:Predictive Value of Tests; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome