Exploratory randomized controlled trial evaluating the impact of a waiting list control design

BMC Medical Research Methodology

Jim McCambridge¹  Kypros Kypri²  John A Cunningham³ 

[1] Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK;Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia;Centre for Addiction and Mental Health, Toronto, Canada

关键词: Brief intervention;    Alcohol;    Alternate explanation;    Waiting list control design;    Research methods;    Randomized controlled trials;   

Others  :  866545
DOI  :  10.1186/1471-2288-13-150

 received in 2013-08-21, accepted in 2013-11-29,  发布年份 2013

【 摘 要 】

Background

Employing waiting list control designs in psychological and behavioral intervention research may artificially inflate intervention effect estimates. This exploratory randomized controlled trial tested this proposition in a study employing a brief intervention for problem drinkers, one domain of research in which waiting list control designs are used.

Methods

All participants (N = 185) were provided with brief personalized feedback intervention materials after being randomly allocated either to be told that they were in the intervention condition and that this was the intervention or to be told that they were in the waiting list control condition and that they would receive access to the intervention in four weeks with this information provided in the meantime.

Results

A total of 157 participants (85%) were followed-up after 4 weeks. Between-group differences were found in one of four outcomes (proportion within safe drinking guidelines). An interaction was identified between experimental manipulation and stage of change at study entry such that participant change was arrested among those more ready to change and told they were on the waiting list.

Conclusions

Trials with waiting list control conditions may overestimate treatment effects, though the extent of any such bias appears likely to vary between study populations. Arguably they should only be used where this threat to valid inference has been carefully assessed.

【 授权许可】

   
2013 Cunningham et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Hart T, Fann JR, Novack TA: The dilemma of the control condition in experience-based cognitive and behavioural treatment research. Neuropsychol Rehabil 2008, 18(1):1-21.
• [2]Barkauskas VH, Lusk SL, Eakin BL: Selecting control interventions for clinical outcome studies. West J Nurs Res 2005, 27(3):346-363.
• [3]Whitehead WE: Control groups appropriate for behavioral interventions. Gastroenterology 2004, 126(1 Suppl 1):S159-S163.
• [4]Gaudiano BA, Herbert JD: Methodological issues in clinical trials of antidepressant medications: perspectives from psychotherapy outcome research. Psychother Psychosom 2005, 74(1):17-25.
• [5]Basham RB: Scientific and practical advantages of comparative design in psychotherapy outcome research. J Consult Clin Psych 1986, 54(1):88-94.
• [6]Hart T, Bagiella E: Design and implementation of clinical trials in rehabilitation research. Arch Phys Med Rehabil 2012, 93(8 Suppl):S117-S126.
• [7]Mohr DC, Spring B, Freedland KE, Beckner V, Arean P, Hollon SD, Ockene J, Kaplan R: The selection and design of control conditions for randomized controlled trials of psychological interventions. Psychother Psychosom 2009, 78(5):275-284.
• [8]Freedland KE, Mohr DC, Davidson KW, Schwartz JE: Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions. Psychosom Med 2011, 73(4):323-335.
• [9]Miller WR, Rollnick S: Motivational Interviewing: Preparing People to Change Addictive Behavior. 2nd edition. New York, NY: Guilford Press; 2002.
• [10]Moyer A, Finney JW: Outcomes for untreated individuals involved in randomized trials of alcohol treatment. J Subst Abuse Treat 2002, 23:247-252.
• [11]de Bruin M, Viechtbauer W, Schaalma HP, Kok G, Abraham C, Hospers HJ: Standard care impact on effects of highly active antiretroviral therapy adherence interventions: A meta-analysis of randomized controlled trials. Arch Intern Med 2010, 170(3):240-250.
• [12]Jenkins RJ, McAlaney J, McCambridge J: Change over time in alcohol consumption in control groups in brief intervention studies: systematic review and meta-regression study. Drug Alcohol Depen 2009, 100(1–2):107-114.
• [13]McCambridge J, de Bruin M, Witton J: The effects of demand characteristics on research participant behaviours in non-laboratory settings: a systematic review. PLoS One 2012, 7(6):e39116.
• [14]Borkovec TD, Grayson JB, Cooper KM: Treatment of general tension: subjective and physiological effects of progressive relaxation. J Consult Clin Psych 1978, 46(3):518-528.
• [15]Harris KB, Miller WR: Behavioral self-control training for problem drinkers: components of efficacy. Psych Addict Behav 1990, 4:82-90.
• [16]Walach H, Bosch H, Lewith G, Naumann J, Schwarzer B, Falk S, Kohls N, Haraldsson E, Wiesendanger H, Nordmann A, et al.: Effectiveness of distant healing for patients with chronic fatigue syndrome: a randomised controlled partially blinded trial (EUHEALS). Psychother Psychosom 2008, 77(3):158-166.
• [17]McCambridge J, Butor-Bhavsar K, Witton J, Elbourne D: Can research assessments themselves cause bias in behaviour change trials? A systematic review of evidence from solomon 4-group studies. PLoS One 2011, 6(10):e25223.
• [18]Hester RK, Squires DD, Delaney HD: The Drinker’s Check-up: 12-month outcomes of a controlled clinical trial of a stand-alone software program for problem drinkers. J Subst Abuse Treat 2005, 28(2):159-169.
• [19]Postel MG, de Haan HA, ter Huurne ED, Becker ES, de Jong CA: Effectiveness of a web-based intervention for problem drinkers and reasons for dropout: randomized controlled trial. J Med Internet Res 2010, 12(4):e68.
• [20]Cunningham JA: Resolving alcohol-related problems with and without treatment: the effects of different problem criteria. J Stud Alcohol 1999, 60(4):463-466.
• [21]McCambridge J, Kypri K: Can simply answering research questions change behaviour? Systematic review and meta analyses of brief alcohol intervention trials. PLoS One 2011, 6(10):e23748.
• [22]Kypri K, McCambridge J, Wilson A, Attia J, Sheeran P, Bowe S, Vater T: Effects of Study Design and Allocation on participant behaviour - ESDA: study protocol for a randomized controlled trial. Trials 2011, 12(1):42. BioMed Central Full Text
• [23]Cunningham JA, Wild TC, Cordingley J, van Mierlo T, Humphreys K: A randomized controlled trial of an internet-based intervention for alcohol abusers. Addiction 2009, 104(12):2023-2032.
• [24]Doumas DM, Hannah E: Preventing high-risk drinking in youth in the workplace: a web-based normative feedback program. J Subst Abuse Treat 2008, 34(3):263-271.
• [25]Doumas DM, Haustveit T: Reducing heavy drinking in intercollegiate athletes: evaluation of a web-based personalized feedback program. Sport Psychol 2008, 22:213-229.
• [26]Doumas DM, McKinley LL, Book P: Evaluation of two Web-based alcohol interventions for mandated college students. J Subst Abuse Treat 2009, 36(1):65-74.
• [27]Cunningham JA: Comparison of two internet-based interventions for problem drinkers: randomized controlled trial. J Med Internet Res 2012, 14(4):e107.
• [28]Dawson DA, Grant BF, Stinson FS, Zhou Y: Effectiveness of the derived Alcohol Use Disorders Identification Test (AUDIT-C) in screening for alcohol use disorders and risk drinking in the US general population. Alcohol Clin Exp Res 2005, 29(5):844-854.
• [29]Babor TF, De La Fuente MF, Saunders JB, Grant M: AUDIT - The Alcohol use Disorders Identification Test: Guidelines for use in Primary Health Care. Geneva, Switzerland: World Health Organization; 1989.
• [30]Saunders JB, Aasland OG, Babor TF, De La Fuente JR, Grant M: Development of the Alcohol Use Disorders Identification Test (AUDIT): WHO collaborative project on early detection of persons with harmful alcohol consumption— II. Addiction 1993, 88:791-804.
• [31]Butt P, Beirness D, Cesa F, Gliksman L, Paradis C, Stockwell T: Alcohol and Health in Canada: A Summary of Evidence and Guidelines for Low-Risk Drinking. Ottawa: Canadian Centre on Substance Abuse; 2011.
• [32]Rollnick S, Heather N, Gold R, Hall W: Development of a short ‘readiness to change’ questionnaire for use in brief, opportunistic interventions among excessive drinkers. Br J Addict 1992, 87:743-754.
• [33]Heather N, Hönekopp J: A revised edition of the Readiness to Change Questionnaire. Newcastle: Northumbria University; 2008.
• [34]Suedfeld P: The subtractive expectancy placebo procedure: a measure of non-specific factors in behavioural interventions. Behav Res Ther 1984, 22(2):159-164.
• [35]Bertholet N, Cheng DM, Palfai TP, Samet JH, Saitz R: Does readiness to change predict subsequent alcohol consumption in medical inpatients with unhealthy alcohol use? Addict behav 2009, 34(8):636-640.
• [36]McCambridge J, Kypri K, Elbourne D: In randomisation we trust? Possible problems in experimenting with people in behavioural intervention trials. J Clin Epidemiol . in press
• [37]Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P: Framework for design and evaluation of complex interventions to improve health. BMJ 2000, 321(7262):694-696.
• [38]Cook TD, Campbell DT: Quasi-Experimentation: Design and Analysis Issues for field Settings. Chicago: Rand McNally; 1979.