Resources

The following publications are recommended as resources for investigators designing and developing trials.

Designing and Reporting

• Pilot trials in health-related behavioral intervention research: Problems, solutions, and recommendations. Freedland KE. Health Psychology. 2020 Jul.
• The selection of comparators for randomized controlled trials of health-related behavioral interventions: recommendations of an NIH expert panel. Freedland KE, King AC, Ambrosius WT, Mayo-Wilson E, Mohr DC, Czajkowski SM, Thabane L, Collins LM, Rebok GW, Treweek SP, Cook TD, Edinger JD, Stoney CM, Campo RA, Young-Hyman D, Riley WT; National Institutes of Health Office of Behavioral and Social Sciences Research Expert Panel on Comparator Selection in Behavioral and Social Science Clinical Trials.  Journal of Clinical Epidemiology. 2019 Feb.
• A guide to the reporting of protocols of pilot and feasibility trials. Thabane, Lehana, and Gillian Lancaster. Pilot and Feasibility Studies. 2019 Feb.
• Control conditions for randomised trials of behavioural interventions in psychiatry: a decision framework. Gold S, Enck P, Hasselmann H, Friede T, Hegerl U, Mohr DC, Otte C. Lancet Psychiatry. 2017 Sep.
• CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. Pilot and Feasibility Studies. 2016 Oct.
• SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. BMJ. 2013 Jan.
• A tutorial on pilot studies: the what, why, and how. BMC Medical Research Methodology. Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. BMC Med Res Methodol. 2010 Jan.
• Caution regarding the use of pilot studies to guide power calculations for study proposals. Kraemer HC, Mintz J, Noda A, Tinklenberg J, Yesavage JA. Archives of General Psychiatry. 2006 May.

Intervention Development

• The NIH Science of Behavior Change Program: Transforming the science through a focus on mechanisms of change - PubMed. Nielsen L, Riddle M, King JW; NIH Science of Behavior Change Implementation Team, Aklin WM, Chen W, Clark D, Collier E, Czajkowski S, Esposito L, Ferrer R, Green P, Hunter C, Kehl K, King R, Onken L, Simmons JM, Stoeckel L, Stoney C, Tully L, Weber W.
• Behaviour Research and Therapy. 2018 Feb.Reenvisioning Clinical Science: Unifying the Discipline to Improve the Public Health. Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Clinical Psychological Science. 2014 Jan.

Fear-Based Mechanisms & Regimen Adherence After Acute Medical Events

• Partner presence in the emergency department and adherence to daily cardiovascular medications in patients evaluated for acute coronary syndrome. Cornelius T, Birk JL, Bourassa K, Umland RC, Kronish IM. Journal of Behavioral Medicine. 2020 Jan.
• Anxiety and Fear of Exercise in Cardiopulmonary Rehabilitation: PATIENT AND PRACTITIONER PERSPECTIVES. Farris SG, Abrantes AM, Bond DS, Stabile LM, Wu WC. Journal of Cardiopulmonary Rehabilitation and Prevention. 2019 Mar.
• Post-traumatic stress disorder symptoms and aversive cognitions regarding physical activity in patients evaluated for acute coronary syndrome. Monane R, Sanchez GJ, Kronish IM, Edmondson D, Diaz KM. European Journal of Preventive Cardiology. 2018 Dec.
• Posttraumatic stress disorder and nonadherence to medications prescribed for chronic medical conditions: A meta-analysis. Taggart Wasson L, Shaffer JA, Edmondson D, Bring R, Brondolo E, Falzon L, Konrad B, Kronish IM. Journal of Psychiatric Research. 2018 Jul.
• Posttraumatic stress disorder due to acute cardiac events and aversive cognitions towards cardiovascular medications. Husain SA, Edmondson D, Kautz M, Umland R, Kronish IM. Journal of Behavioral Medicine. 2017 Dec.

Choosing Journals 

• For randomized clinical trials (fees dependent on the author's institution): Trials
• For interventions with a digital component (publication fees): JMIR Research Protocols
• For publishing protocol papers and interesting trial design issues (fees dependent on publication type): Contemporary Clinical Trials
• Open-access journal that considers papers not accepted by Contemporary Clinical Trials (publication fees): Contemporary Clinical Trials Communications
• Open access journal that publishes a breadth of research, including, potentially, protocol and pilot study findings; (publication fees): PLOS One
• Open-access journal that publishes interesting study design protocols and results (publication fees): BMJ Open
• BMJ subsidiary journal that aims to publish protocol and results papers relevant to pilot studies (publication fees): Pilot and Feasibility Studies
• Lower impact journal that may publish pilot study results for behavioral interventions (publication fees): Frontiers in Psychiatry
• For articles that are  published online first, which reduces time from acceptance to publication: Clinical Trials