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Can Attention Control Conditions Have Detrimental Effects on Behavioral Medicine Randomized Trials
Meyers Primary Care Institute Publications and Presentations
  • Sherry L. Pagoto, University of Massachusetts Medical School
  • Mary McGrae McDermott, Northwestern University
  • George W. Reed, University of Massachusetts Medical School
  • Philip Greenland, Northwestern University
  • Kathleen M. Mazor, University of Massachusetts Medical School
  • Judith K. Ockene, University of Massachusetts Medical School
  • Matthew C. Whited, University of Massachusetts Medical School
  • Kristin L. Schneider, University of Massachusetts Medical School
  • Bradley M. Appelhans, Northwestern University
  • Katherine Leung, University of Massachusetts Medical School
  • Philip A. Merriam, University of Massachusetts Medical School
  • Ira S. Ockene, University of Massachusetts Medical School
UMMS Affiliation
Meyers Primary Care Institute; Department of Medicine, Division of Cardiovascular Medicine; Division of Preventive and Behavioral Medicine
Date
11-28-2012
Document Type
Article
Medical Subject Headings
Randomized Controlled Trials as Topic; Behavioral Medicine
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.

Trial Registration:clinicaltrials.gov Identifier: NCT00217919.

Comments

Citation: Psychosom Med. 2012 Nov 28. Link to article on publisher's site

Related Resources
Link to Article in PubMed
PubMed ID
23197844
Citation Information
Sherry L. Pagoto, Mary McGrae McDermott, George W. Reed, Philip Greenland, et al.. "Can Attention Control Conditions Have Detrimental Effects on Behavioral Medicine Randomized Trials" (2012) ISSN: 0033-3174 (Linking)
Available at: http://works.bepress.com/sherry_pagoto/68/