title: Cognitive Interventions and Nutritional Supplements (The CINS Trial): A Randomized Controlled, Multicenter Trial Comparing a Brief Intervention With Additional Cognitive Behavioral Therapy, Seal Oil, and Soy Oil for Sick-Listed Low Back Pain Patients.
abstract: A randomized controlled trial.
  
  
  
  The aim of this study was to evaluate whether a tailored and manualized cognitive behavior therapy (CBT) or nutritional supplements of seal oil and soy oil had any additional benefits over a brief cognitive intervention (BI) on return to work (RTW).
  
  
  
  Brief intervention programs are clinically beneficial and cost-effective for patients with low back pain (LBP). CBT is recommended for LBP, but evidence on RTW is lacking. Seal oil has previously been shown to have a possible effect on muscle pain, but no randomized controlled trials have so far been carried out in LBP patients.
  
  
  
  Four hundred thirteen adults aged 18 to 60 years were included. Participants were sick-listed 2 to 10 months due to LBP. Main outcome was objectively ascertained work participation at 12-month follow-up. Participants were randomly assigned to BI (n = 100), BI and CBT (n = 103), BI and seal oil (n = 105), or BI and soy oil (n = 105). BI is a two-session cognitive, clinical examination program followed by two booster sessions, while the CBT program is a tailored, individual, seven-session manual-based treatment.
  
  
  
  At 12-month follow-up, 60% of the participants in the BI group, 50% in the BI and CBT group, 51% in the BI and seal oil group, and 53% in the BI and soy oil group showed reduced sick leave from baseline, and had either partly or fully RTW. The differences between the groups were not statistically significant (χ = 2.54, P = 0.47). There were no significant differences between the treatment groups at any of the other follow-up assessments either, except for a significantly lower sick leave rate in the BI group than the other groups during the first 3 months of follow-up (χ = 9.50, P = 0.02).
  
  
  
  CBT and seal oil had no additional benefits over a brief cognitive intervention on sick leave. The brief cognitive intervention alone was superior in facilitating a fast RTW.
  
  
  
  2.
authors.affiliation: Uni Research Health, Bergen, Norway.|Oslo University Hospital, Oslo, Norway.|Department of Psychology, Faculty of Social Sciences, University of Oslo, Oslo.
authors.forename: Silje E
authors.initials: SE
authors.lastname: Reme
authors.affiliation: Uni Research Health, Bergen, Norway.|Department of Health Promotion, University College of Southeast Norway, Oslo, Norway.
authors.forename: Torill H
authors.initials: TH
authors.lastname: Tveito
authors.affiliation: Department of Health Promotion and Development, University of Bergen, Bergen, Norway.
authors.forename: Anette
authors.initials: A
authors.lastname: Harris
authors.affiliation: Department of of Clinical Dentistry, University of Bergen, Bergen, Norway.
authors.forename: Stein Atle
authors.initials: SA
authors.lastname: Lie
authors.affiliation: Department of Economics, University of Bergen, Bergen, Norway.
authors.forename: Astrid
authors.initials: A
authors.lastname: Grasdal
authors.affiliation: Department of Health Promotion and Development, University of Bergen, Bergen, Norway.|Department of Research and Development, Clinic Physical Medicine and Rehabilitation, Vestfold Hospital Trust, T⊘nsberg, Norway.
authors.forename: Aage
authors.initials: A
authors.lastname: Indahl
authors.affiliation: Oslo University Hospital, Oslo, Norway.
authors.forename: Jens Ivar
authors.initials: JI
authors.lastname: Brox
authors.affiliation: Department of Psychiatry, Haukeland University Hospital, Bergen, Norway.
authors.forename: Tone
authors.initials: T
authors.lastname: Tangen
authors.affiliation: Department of Physical Medicine and Rehabilitation, Innlandet Hospital Trust, Ottestad, Norway.
authors.forename: Eli Molde
authors.initials: EM
authors.lastname: Hagen
authors.affiliation: Department of Physical Medicine and Rehabilitation, St Olav University Hospital, Trondheim, Norway.|The Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Sigmund
authors.initials: S
authors.lastname: Gismervik
authors.affiliation: Unicare, Friskvernklinikken, Asker, Norway.
authors.forename: Arit
authors.initials: A
authors.lastname: Ødegård
authors.affiliation: National Institute of Nutrition and Seafood Research (NIFES), Bergen, Norway.
authors.forename: Livar
authors.initials: L
authors.lastname: Fr Yland
authors.affiliation: The Department of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, Norway.|National Competence Centre for Complex Disorders, St Olav's Hospital, Trondheim, Norway.
authors.forename: Egil A
authors.initials: EA
authors.lastname: Fors
authors.affiliation: Department of Psychological Medicine, King's College London, London, UK.
authors.forename: Trudie
authors.initials: T
authors.lastname: Chalder
authors.affiliation: Uni Research Health, Bergen, Norway.|Department of Sport and Physical Activity, Bergen University College, Bergen, Norway.
authors.forename: Hege R
authors.initials: HR
authors.lastname: Eriksen
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D019587:Dietary Supplements; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D018582:Sick Leave; D016896:Treatment Outcome; D055815:Young Adult