title: Can attention control conditions have detrimental effects on behavioral medicine randomized trials?
abstract: OBJECTIVE
  Attention control (AC) conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance about which behavioral interventions and outcomes merit AC is available in the literature. The primary aim of the present study is to demonstrate a scenario in which use of AC in a behavioral randomized trial was unnecessary and possibly detrimental.
  
  
  METHODS
  Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered counseling intervention reduced low-density lipoprotein cholesterol levels in 355 participants with peripheral arterial disease, compared with AC and usual care (UC) conditions. The patient-centered counseling intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched telephone-delivered health education, and the UC condition consisted of an educational pamphlet.
  
  
  RESULTS
  At 12-month follow-up, the mean low-density lipoprotein cholesterol changes were -11.1 and -6.8 mg/dL in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased the use or dose intensity of medication was significantly lower in AC than in UC: 17.5% versus 30.5% (p=.03). No significant difference in other outcomes was observed between AC and UC.
  
  
  CONCLUSIONS
  AC has significantly worse medication outcomes, and there is no indication of a therapeutic effect on other end points. Implications for the use of AC in behavioral randomized trials are discussed.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00217919.
authors.affiliation: Division of Preventive and Behavioral Medicine, Department of Medicine, University of Massachusetts Medical School, 55 Lake Avenue North, Worcester, MA 01760, USA. Sherry.pagoto@umassmed.edu
authors.forename: Sherry L
authors.initials: SL
authors.lastname: Pagoto
authors.forename: Mary M
authors.initials: MM
authors.lastname: McDermott
authors.forename: George
authors.initials: G
authors.lastname: Reed
authors.forename: Philip
authors.initials: P
authors.lastname: Greenland
authors.forename: Kathy M
authors.initials: KM
authors.lastname: Mazor
authors.forename: Judith K
authors.initials: JK
authors.lastname: Ockene
authors.forename: Matt
authors.initials: M
authors.lastname: Whited
authors.forename: Kristin
authors.initials: K
authors.lastname: Schneider
authors.forename: Brad
authors.initials: B
authors.lastname: Appelhans
authors.forename: Kathy
authors.initials: K
authors.lastname: Leung
authors.forename: Philip
authors.initials: P
authors.lastname: Merriam
authors.forename: Ira
authors.initials: I
authors.lastname: Ockene
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D059031:Anticipation, Psychological; D001288:Attention; D001524:Behavioral Medicine; D008078:Cholesterol, LDL / Q000378:metabolism; D035061:Control Groups; D003376:Counseling; D004041:Dietary Fats / Q000008:administration & dosage; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D055118:Medication Adherence / Q000523:psychology; D010353:Patient Education as Topic / Q000379:methods; D058729:Peripheral Arterial Disease / Q000378:metabolism / Q000523:psychology / Q000628:therapy*; D011369:Professional-Patient Relations; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D020377:Self Efficacy; D013689:Telephone; D016896:Treatment Outcome
chemical_list: D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D004041:Dietary Fats