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A Health Education Intervention as the Control Condition in the CTN-0037 STRIDE Multi-Site Exercise Trial: Rationale and Description.

Mental Health and Physical Activity 2014;7(1):37-41. [doi: 10.1016/j.mhpa.2013.12.001]

Chad D. Rethorst, PhD (UT Southwestern Medical Center, TX Node), Tracy L. Greer, PhD (UT Southwestern Medical Center, TX Node), Bruce D. Grannemann (UT Southwestern Medical Center, TX Node), Kolette M. Ring (UT Southwestern Medical Center, TX Node), Bess H. Marcus, PhD (University of California San Diego, FNA Node), Madhukar H. Trivedi, MD (UT Southwestern Medical Center, TX Node).

The selection of a control condition in a randomized controlled trial (RCT) is critical in determining the effect of the experimental treatment. While the use of a placebo pill can be an ideal control in pharmaceutical trials, RCTs of behavioral interventions present unique challenges in the selection and implementation of the appropriate control condition. Investigators must not only consider the control condition's ability to protect against threats to internal validity and its plausibility as a possible intervention, but must also carefully implement the control condition so it does not introduce bias from either the investigators or the participants. The purpose of this paper is to provide the rationale for the use of a health education intervention (HEI) as the control condition in National Drug Abuse Treatment Clinical Trials Network protocol CTN-0037, "Stimulant Reduction Intervention Using Dosed Exercise (STRIDE)." This paper describes the careful design of the HEI to ensure proper implementation and discusses alternative control conditions considered. (Article (Peer-Reviewed), PDF, English, 2014)

Keywords: CTN protocol development | Exercise | Research design | Stimulant abuse | Mental Health and Physical Activity (journal)

Document No: 1089, PMID: 24729793, PMCID: PMC3979565.

Submitted by CTN Dissemination Librarians, 8/18/2013.

Grannemann, Bruce D.
Greer, Tracy L. mail
Marcus, Bess H. mail
Rethorst, Chad D. mail
Ring, Kolette M.
Trivedi, Madhukar H. mail
NIDA-CTN-0037 www
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