Motivational interviewing in intensive treatment of Type 2 diabetes detected by screening in general practice.

Motivational interviewing in intensive treatment of Type 2 diabetes detected by screening in general practice. Overall effect of a course in Motivational interviewing PhD thesis Sune Leisgaard Mørck Rubak Department and Research Unit of General Practice Faculty of Health Sciences University of Aarhus Denmark 2005

PhD thesis Motivational interviewing in intensive treatment of Type 2 diabetes in general practice. Overall effect of a course in Motivational interviewing Sune Rubak 1 st edition, 2005 Print: Fællestrykkeriet for Sundhedsvidenskab, University of Aarhus ISBN This PhD thesis has been accepted for the defence of the medical PhD by the Faculty of Health Science, University of Aarhus and was defended on February 22th, 2005. Supervisors: Professor, MD, GP, PhD Bo Christensen, Director of Department of General Practice, University of Aarhus, Denmark Associate Professor, MD, PhD Annelli Sandbæk, Department of General Practice, University of Aarhus, Denmark Professor, MD, GP, DMSc Torsten Lauritzen, Department of General Practice, University of Aarhus, Denmark Opponents: Professor, Consultant, MD, DMSc Povl Munk-Jørgensen, Director of Research Unit of Psychiatric Department, Aalborg Hospital, University of Aarhus, Denmark (Chair) Associate Professor, Consultant, MD, DMSc Birger Thorsteinsson, Department of Medicine F, Hillerød Hospital, Denmark Professor, MD, GP, DMSc Flemming Bro, Director of Department of General Practice, University of Southern Denmark, Denmark Steno Diabetes Center, Gentofte & Department and Research Unit of General Practice University of Aarhus Vennelyst Boulevard 6 DK-8000 Aarhus C Denmark Email: sune.rubak@dadlnet.dk or sr@alm.au.dk www.alm.au.dk All rights reserved. No parts of this publication may be reproduced, stored in retrieval systems, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without indication of source.

Preface I

Outline of this PhD thesis and the PhD project This thesis is based on the ADDITION-study, the Anglo-Danish-Ducth study of intensive treatment in people with screen-detected diabetes in primary care. The ADDITION-study was developed and implemented in cooperation between the Department of General Practice and the Steno Diabetes Centre. The ADDITION-study investigates the effects of screening and intensive treatment including poly-pharmacological treatment and behavioural change, on patients with Type 2 diabetes. The ADDITION-study is an ongoing study encompassing three countries, The Netherlands, England and Denmark. In Denmark, the study is represented in five counties, Aarhus, Copenhagen, Ringkoebing, Ribe and South Jutland counties. In this thesis, the effect of Motivational interviewing was evaluated in a cluster-randomised controlled trial carried out in the counties of Aarhus and Copenhagen, Denmark, 2001. This PhD thesis is a part of the ADDITIONstudy. It specifically explores the effect after one year of Motivational interviewing on newly diagnosed Type 2 diabetes patients detected by screening. This thesis focuses on whether GPs using Motivational interviewing can increase adherence to and effect of intensive treatment of Type 2 diabetes patients risk profile, thus reaching treatment goals. The concept of Motivational interviewing is introduced in Chapter 1, which also offers a summary of the use of this concept in research and practice and a presentation of the rationale why Motivational interviewing was chosen as the means of intervention. The aim of the PhD study is presented at the end of Chapter 1. Chapter 2 features a review of previous research on Motivational interviewing and its implications for practice and a meta-analysis on its effect. In Chapter 3 the effects of a training course in Motivational interviewing for general practitioners (GPs) are presented. The chapter addresses the questions whether the GPs aquired the methods of Motivational interviewing and if they used Motivational interviewing in their daily work. The next step focused on the effect of Motivational interviewing on patients lifestyle and behavioural change. Chapter 4 hence addresses the questions whether the GPs use of Motivational interviewing changed the patients contemplation of changing behaviour and if they did, indeed, change lifestyle behaviour. Finally, the effects of Motivational interviewing on patients risk profile and adherence to intensive treatment are outlined in Chapter 5. Chapters 6 to 9 offer a comprehensive and more general discussion of the methods used and the results presented in the articles, adding perspective to the research questions posed. Finally, Chapters 10 and 11 present English and Danish summaries. References used throughout the thesis are listed in citation order. Appendices provide an outline of the study flowcharts, the educational programme of Motivational interviewing and the questionnaires and case record forms in Danish (Appendix A-D). II

This PhD thesis is based on the following articles: I. Rubak S, Christensen B, Sandbaek A, Lauritzen T. Motivational interviewing, a systematic review and a meta-analysis. British Journal of General Practice. Accepted 2004. II. III. IV. Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Christensen B. How does an education and training course in Motivational interviewing influence general practitioner s professional behaviour. ADDITION Denmark. British Journal of General Practice. Submitted 2004. Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Christensen B. Effect of Motivational interviewing on beliefs and behaviour among patients with Type 2 diabetes detected by screening. ADDITION Denmark. Prepared for publication 2004. Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Christensen B. No effect of Motivational interview on risk profile in patients with Type 2 diabetes detected by screening. A one-year follow-up of a RCT. ADDITION Denmark. Prepared for publication 2004. III

Motivation After my graduation from the University of Aarhus in 1998, I began my postgraduate career as a house officer. At this time I came into contact with the Department of General Practice while doing a small research project. During this project, I felt that the department had pleasant, productive and appealing atmosphere. However, I started as a senior house officer at the Department of Paediatrics, Skejby Hospital, where I was much inspired by the clinical work with children. I found myself standing with one leg in two worlds, General Practice or Paediatrics. This dilemma was put into perspective by my family situation as a husband and father of two children, Johan and Astrid. The challenge was to combine this wonderful family life with a productive and meaningful, clinical career and a PhD presented itself as a natural solution. The Department of General Practice proposed a project on Motivational interviewing. I had a meeting with Professor Carl-Erik Mabeck, my mentor in Motivational interviewing, and was intrigued by the possibilities of Motivational interviewing and the lack of research in this field. This was a method which, if it proved effective, could be used in both General Practice and in Paediatrics. After having caught up on the subject of Motivational interviewing, I decided that this was the right area for me to do further research in and began my PhD project. Acknowledgements The study would never have succeeded had it not been for the tremendous support I have received from my colleagues, from research funds and from my family. My colleagues in general practice in the County of Aarhus and the County of Copenhagen have involved themselves strongly in the project and accepted to be randomized and then undertaken all the hard work of attending courses, implementing the methods and recruiting the patients to the project. I am truly grateful for their participation and support for this project. I would also like to thank the practice staff and all the patients who spent much time filling in the questionnaires and case record forms. I am indebted to my supervisors, Professor Bo Christensen for being there all the time during the study, Associate Professor Annelli Sandbæk for having paid close attention and for having the feel of the project in its different phases, Professor Torsten Lauritzen and Professor Knut Borch- Johnsen for their work launching and supporting the ADDITION-study. Finally, I am greatly indebted to my mentor Professor Carl-Erik Mabeck for sharing his profound knowledge on Motivational interviewing, his guidance and willingness to provide the right amount of inspiration and motivation when needed. I owe my sincere thanks to the flourishing research atmosphere at the Department and Research Unit of General Practice. My research colleagues have been helpful in constructive discussions, in practical matters of all kinds. I would also like to thank Hans Christian Kjeldsen and Kaare Mai for good company, our discussions in the office on everything else than research. The help provided by all the partners in the PhD project, the ADDITION-study, from the County Health Service, the Department of Health Insurance and all the laboratories on the hospitals has been exceptional, as has their aid in data retrieval and assistance in sorting out problems encountered during the study. The choice and use of statistical methods for data analysis was, of course, an interesting challenge, and I owe my special thanks to the Department of Biostatistics, Associate Professor, PhD Morten Frydenberg, who has been most helpful and patient with my queries and questions. IV

I appreciate all the help that I received from the secretaries, Eva Therkildsen and Helle Hjort Pedersen at the Department of General Practice, Karen Wolsing, Ynna Margot Nielsen and Inge Krogh at the ADDITION-study, Elsebeth Schreiber at the Specific Training for General Practice and Birthe Brauneiser and Eva Højmark Pedersen at the Research Unit of General Practice. I am greatly thankful for the assistance provided by Bjarne Benner Svendsen, Lars Venge Olesen and Tonni Juul Hansen in relation to designing questionnaires, handling the retrieval of data and the database, solving all technical problems at hand and keeping virus, worms and other creatures out of my computer. I acknowledge the linguistic help of Professor Morten Pilegaard in revising the text. I owe a dept of gratitude to the Department of General Practice for housing me and for helping me administer the project economy. Considerable financial support was essential for the implementation of the study. The PhD study is funded by The Danish National Research Foundation for General Practice, the Danish Medical Association Research Fund, the Diabetes Associations foundation for Scientific Research. Furthermore the PhD study could not have been carried through without financial support given to the ADDITION study DK by: The National health service in the counties of Copenhagen, Aarhus, Ringkøbing, Ribe, South Jutland, all in Denmark. The Danish National Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, The Aarhus University Research Foundation, Novo Nordic Foundation. Unrestricted grants from Novo Nordic AS, Novo Nordic Scandinavia AS, ASTRA Denmark, Pfizer Denmark, GlaxoSmithKline Pharma Denmark, SERVIER Denmark A/S, HemoCue Denmark A/S. Finally, I am greatly indebted to my family. My father has provided eminent support during the study. My father has the ability to grasp all aspects of a problem, keep an overview, and yet still focus on how to solve each of the specific problems. My mother and sister have kept me going with their loving support and positive attitude. My children give me their unconditioned love and make me believe everything is possible in this world. My wife, Dorte, has inspired me in many parts of the project phases and I have enjoyed her ultimate confidence in my capabilities. I can only hope that I will be able to return this some day. Sune Rubak Aarhus, February 2005 V

Abbreviations BMI CI CPR.no DIRQ DBP DSCAQ F-H F-M GP HbA1c HCCQ HDL C-group ICC IHD IPQ LDL I-group OGTT OR PMDIQ RCT SD SBP Sum-qst T-Chol Tgly TSRQ T2D Body Mass Index Confidence Interval Civil Personal Registration number Diabetes Illness Representation Questionnaire Diastolic Blood Pressure (mmhg) Diabetes Self-Care Activities Questionnaire Number of days pr. week with hard physical activity (example: heavy lifting, aerobics, playing single tennis) Number of days pr. week with moderate physical activity (example: bicycling in moderate tempo, playing double in tennis). General Practitioner Haemoglobin A 1c (% GHb) Health Care Climates Questionnaire High Density Lipoproteins (mmol/l) Control group in the PhD study of general practitioners receiving no formal education or training in Motivational interviewing (C-group is used in the chapters 1, 6-10 of this PhD thesis, otherwise abbreviations for study groups have been specified in each of the remaining chapters 2-5) The Intra-Cluster Correlation Coefficient Ischemic Heart Disease Illness Perception Questionnaire Low Density Lipoproteins (mmol/l) Intervention group in the PhD study of general practitioners trained in Motivational interviewing (I-group is used in the chapters 1, 6-10 of this PhD thesis, otherwise abbreviations for study groups have been specified in each of the remaining chapters 2-5) Oral Glucose Tolerance Test Odds Ratio Personal Models of Diabetes Interview Questionnaire Randomised Controlled Trial Standard Deviation Systolic Blood Pressure (mmhg) Sum scoring from questionnaire Blood total Cholesterol (mmol/l) Triglycerid (mmol/l) Treatment Self-Regulation Questionnaire Type 2 Diabetes Mellitus VI

CONTENTS CHAPTER 1...1 GENERAL INTRODUCTION...2 THE CONCEPT OF MOTIVATIONAL INTERVIEWING...2 DESCRIPTION OF THE CONCEPT OF MOTIVATIONAL INTERVIEWING...2 USE OF MOTIVATIONAL INTERVIEWING IN RESEARCH AND PRACTICE...3 THE ADDITION-STUDY...4 AIM OF PHD THESIS...4 CHAPTER 2...5 MOTIVATIONAL INTERVIEWING: A SYSTEMATIC REVIEW AND META-ANALYSIS...5 ABSTRACT...6 INTRODUCTION...7 METHODS...8 SEARCH STRATEGY...8 SELECTION...10 QUALITATIVE DATA SYNTHESIS...10 VALIDITY ASSESSMENT, DATA EXTRACTION...11 QUANTITATIVE DATA SYNTHESIS...11 STUDY CHARACTERISTICS...11 RESULTS...11 TRIAL FLOW...11 VALIDITY ASSESSMENT, DATA EXTRACTION...12 QUANTITATIVE DATA SYNTHESIS...14 QUALITATIVE DATA SYNTHESIS...17 STUDY CHARACTERISTICS...17 DISCUSSION...17 MAIN FINDINGS...17 STRENGTH AND LIMITATIONS...18 DETAILED FINDINGS...18 IMPLICATIONS FOR FUTURE RESEARCH...19 IMPLICATIONS FOR PRACTICE...19 CONCLUSION...19 CHAPTER 3...21 HOW DOES AN EDUCATION AND TRAINING COURSE IN MOTIVATIONAL INTERVIEWING INFLUENCE GENERAL PRACTITIONER S PROFESSIONAL BEHAVIOUR. ADDITION DENMARK...21 ABSTRACT...22 INTRODUCTION...23 METHODS...24 STUDY GROUP...24 METHOD OF INTERVENTION...26 MEASUREMENTS...26 STATISTICAL METHOD...28 RESULTS...28 STUDY SAMPLE CHARACTERISTICS...28 VII

STUDY DATA AND ANALYSES...28 DISCUSSION...31 MAIN FINDINGS...31 STRENGTH AND LIMITATIONS...31 DETAILED FINDINGS...32 IMPLICATIONS FOR FUTURE RESEARCH...32 CONCLUSION...33 CHAPTER 4...35 EFFECT OF MOTIVATIONAL INTERVIEWING ON BELIEFS AND BEHAVIOUR AMONG PATIENTS WITH TYPE 2 DIABETES DETECTED BY SCREENING. ADDITION DENMARK....35 ABSTRACT...36 INTRODUCTION...37 METHODS...38 STUDY GROUP...38 METHOD OF INTERVENTION...40 MEASUREMENTS...40 STATISTICAL METHOD...41 RESULTS...42 DISCUSSION...45 MAIN FINDINGS...45 STRENGTH AND LIMITATIONS...45 DETAILED FINDINGS...46 IMPLICATIONS FOR FUTURE RESEARCH...46 CONCLUSION...47 CHAPTER 5...49 NO EFFECT OF MOTIVATIONAL INTERVIEW ON RISK PROFILE IN PATIENTS WITH TYPE 2 DIABETES DETECTED BY SCREENING. A ONE YEAR FOLLOW-UP OF A RCT. ADDITION DENMARK...49 ABSTRACT...50 INTRODUCTION...51 METHOD...51 STUDY GROUP...51 METHOD OF INTERVENTION...53 MEASUREMENTS...53 RISK PROFILE...53 HEALTH CARE SERVICES...54 SELF-REPORTED DATA...54 STATISTICAL METHOD...54 RESULTS...54 DISCUSSION...57 MAIN FINDINGS...57 STRENGTH AND LIMITATIONS...57 DETAILED FINDINGS...58 IMPLICATIONS FOR FUTURE RESEARCH AND PRACTICE...58 CONCLUSION...59 VIII

CHAPTER 6...61 GENERAL DISCUSSION OF METHODS...61 INTRODUCTION...62 SETTING OF THE STUDY...62 DESIGN...62 CLUSTER RANDOMISED CONTROLLED TRIAL...63 BIAS...63 BLINDING...63 STUDY EVALUATION...64 INTERVENTION...64 MONITORING THE INTERVENTION...64 ADHERENCE TO MOTIVATIONAL INTERVIEWING...65 CHANGING AND SUSTAINING LONG-TERM CHANGE OF PROFESSIONAL BEHAVIOUR...65 MEASURING METHODS...66 GENERAL PRACTITIONER QUESTIONNAIRE...66 PATIENT QUESTIONNAIRE...66 CASE RECORD FORMS...68 BLOOD SAMPLE DATA...68 NATIONAL HEALTH SERVICE REGISTRY DATA...68 STATISTICAL METHODS...69 POTENTIAL GENERALISATION OF OUTCOME...71 CHAPTER 7...73 GENERAL DISCUSSION OF RESULTS...73 INTRODUCTION...74 DISCUSSION OF RESULTS...74 CONDITION FOR OBTAINING AN EFFECT OF THE TRAINING COURSE IN MOTIVATIONAL INTERVIEWING...74 EFFECT OF MOTIVATIONAL INTERVIEWING ON GENERAL PRACTITIONERS...75 EFFECT OF MOTIVATIONAL INTERVIEWING ON PATIENT BEHAVIOUR CHANGE AND PATIENT RISK PROFILE...75 CHAPTER 8...77 CONCLUSION...78 CHAPTER 9...79 PERSPECTIVES AND IMPLICATIONS FOR FUTURE RESEARCH AND PRACTICE...80 PERSPECTIVES...80 IMPLICATIONS FOR FUTURE RESEARCH...80 IMPLICATIONS FOR PRACTICE...80 CHAPTER 10...81 ENGLISH SUMMARY...82 GENERAL INTRODUCTION...82 AIM OF PHD THESIS...82 MOTIVATIONAL INTERVIEWING, A SYSTEMATIC REVIEW AND A META-ANALYSIS. (ARTICLE 1)...83 HOW DOES AN EDUCATION AND TRAINING COURSE IN MOTIVATIONAL INTERVIEWING INFLUENCE GENERAL PRACTITIONER S PROFESSIONAL BEHAVIOUR. (ARTICLE 2)...83 IX

EFFECT OF MOTIVATIONAL INTERVIEWING ON BELIEFS AND BEHAVIOUR AMONG PEOPLE WITH TYPE 2 DIABETES DETECTED BY SCREENING. (ARTICLE 3)...83 NO EFFECT OF THE MOTIVATIONAL INTERVIEW ON RISK PROFILE IN PEOPLE WITH TYPE 2 DIABETES DETECTED BY SCREENING. A ONE YEAR FOLLOW-UP OF A RCT. (ARTICLE 4)...84 GENERAL DISCUSSION OF METHODS....84 GENERAL DISCUSSION OF RESULTS...84 CONCLUSION...84 PERSPECTIVES AND IMPLICATIONS FOR FUTURE RESEARCH AND PRACTICE...84 CHAPTER 11...85 DANSK RESUMÉ...85 INTRODUKTION...86 FORMÅL MED PHD AFHANDLINGEN....86 DEN MOTIVERENDE SAMTALE, ET SYSTEMATISK REVIEW OG EN META-ANALYSE. (ARTIKEL 1)...87 HVORDAN PÅVIRKER ET KURSUS I DEN MOTIVERENDE SAMTALE PRAKTISERENDE LÆGERS PROFESSIONELLE ADFÆRD. (ARTIKEL 2)...87 EFFEKTEN AF DEN MOTIVERENDE SAMTALE PÅ SCREENEDE TYPE 2 DIABETES PATIENTERS OVERBEVISNING OG ADFÆRD. (ARTIKEL 3)...87 INGEN EFFEKT AF DEN MOTIVERENDE SAMTALE PÅ SCREENEDE TYPE 2 DIABETES PATIENTERS RISIKO PROFIL. EN 1-ÅRS OPFØLGNING AF ET RANDOMISERET KONTROLLERET FORSØG. (ARTIKEL 4)...88 GENEREL DISKUSSION AF METODERNE...88 GENEREL DISKUSSION AF RESULTATER...88 KONKLUSION...88 PERSPEKTIVER OG STUDIETS KONSEKVENSER FOR FREMTIDIG FORSKNING OG PRAKSIS...88 REFERENCES...89 APPENDICES...103 APPENDIX A. FLOWCHART OF THE ADDITION STUDY, OF THE PHD STUDY, AND TABLE 1 APPENDIX B. APPENDIX C. APPENDIX D. EDUCATIONAL PROGRAMME OF MOTIVATIONAL INTERVIEWING QUESTIONNAIRES IN DANISH USED IN THE STUDY CASE RECORD FORMS IN DANISH USED IN THE STUDY X

Chapter 1 General introduction 1

The concept of Motivational interviewing In this thesis Motivational interviewing as a concept is based on the definition of Miller and Rollnick presented in their book Motivational interviewing, preparing people to change addictive behaviour, 2002 1;2. Miller and Rollnick defined Motivational interviewing as a directive, client-centred counselling style for eliciting behaviour change by helping clients to explore and resolve ambivalence. The concept of Motivational interviewing evolved from experience with the treatment of alcoholism and was described by Miller in 1983 3. This early experience developed into a coherent theory and detailed description of clinical procedures was provided in Miller and Rollnick (1991) 1, a work which was recently revised (2002) 2. Miller and Rollnick s theory also draws inspiration from Carl Rogers work on non-directive counselling and behavioural change theory described in 1951 4. Previous research and the use of the term or concept Motivational interviewing has made it a more comprehensive concept that also often includes aspects from other psychological models of behaviour change and different approaches to the patient-doctor relationship. These new conceptual elements border on Motivational interviewing, and some even rest on the same theoretical foundation. However, in important respects, they are not coherent with the core concept of Motivational interviewing formulated by Miller and Rollnick. Description of the concept of Motivational interviewing Motivational interviewing is based on a characteristic counselling style including different techniques used in the patient-doctor relationship. The examination and resolution of ambivalence is the central purpose in non-directive counselling. However, the counsellor is intentionally directive in pursuing this goal. Motivational interviewing is a particularly way of helping clients recognize problems and change their behaviour accordingly. It is considered particularly useful with patients who are reluctant to change or ambivalent about changing their behaviour. The strategies of Motivational interviewing are more persuasive than coercive, more supportive than argumentative, and the overall goal is to increase the client s intrinsic motivation so that change arises from within rather than being imposed from without 2. The spirit and characteristics of Motivational interviewing is captured in the following key points 2. 1. Motivation to change is elicited from the client, and not imposed from without. Other motivational approaches have emphasised coercion, persuasion, constructive confrontation. Such strategies may have their place in evoking change, but they are quite different in spirit from Motivational interviewing which relies upon identifying and mobilising the client's intrinsic values and goals to stimulate behaviour change. 2. Ambivalence takes the form of a conflict between two courses of action (e.g. indulgence versus restraint), each of which has perceived benefits and costs associated with it. The counsellor's task is to facilitate expression of both sides of the ambivalence impasse, and guide the client toward an acceptable resolution that triggers change. The specific strategies of Motivational interviewing are designed to elicit, clarify, and resolve ambivalence in a client-centred and respectful counselling atmosphere. 2

3. The counselling style is generally a quiet and eliciting one. More aggressive strategies, sometimes guided by a desire to "confront client denial," easily slip into pushing clients to make changes for which they are not ready, and therefore will not accommodate afterwards. 4. Readiness to change is not a client trait, but a fluctuating product of interpersonal interaction. Resistance and "denial" are seen not as client traits, but as feedback regarding counsellor behaviour. Client resistance is often a signal that the counsellor is assuming greater readiness to change than is the case, and it is a cue that the counsellor needs to modify motivational strategies. 5. Eliciting and reinforcing the clients in their motivational behaviour towards problem recognition, concerns, desire, intention, responsibility and ability to change. The client s belief in the ability to carry out and succeed achieving a specific goal is essential. 6. The therapeutic relationship is more like a partnership or companionship than expert/recipient roles. The counsellor respects the client s autonomy and freedom of choice and consequences regarding his or her own behaviour. 7. Motivational interviewing is not merely a set of techniques that are applied in treatment of clients. It is an interpersonal style, not restricted to formal counselling settings. It is a subtle balance of directive and client-centred components shaped by a guiding philosophy and understanding of what triggers change. Use of Motivational interviewing in research and practice Motivational interviewing is a counselling style and a method that is both rather well documented and scientifically tested, and it is viewed as a useful intervention strategy for changing behaviour 5. It has been used and evaluated internationally especially in the last decade, in relation to the following main areas: 1) addiction (alcohol abuse and drug addiction), 2) change in lifestyle (smoking cessation, weight-loss, physical activity, asthma and diabetes treatment), and 3) adherence (to treatment and to control, encounters of follow-up, counselling meetings). Motivational interviewing has been deployed by various health care providers, including psychologist, doctors, nurses, dieticians and midwifes. However, current studies have focused on its effect in hospital settings with no or little attention to how the methods could be implemented and applied afterward in the daily clinical work especially in general practice. A few studies have been conducted in a clinical setting allowing to continue the process of using Motivational interviewing in daily clinical work after project termination 6-10. This thesis explores the effect of Motivational interviewing in general practice. Motivational interviewing has only recently been introduced in Denmark, but its use has been rising over the past years and it has been deployed in different scientific and clinical settings. Thus, in 2000 the Danish College of General Practitioners issued an introduction booklet on Motivational interviewing 11, which was mailed to all members of the Danish Medical Association. Furthermore, a Danish book on the subject written by Professor Carl Erik Mabeck was issued in more than 10000 copies 12 and more than 30 residential courses in Motivational interviewing have been conducted by Professor Carl Erik Mabeck since. These courses attracted mainly nurses, however, a number of GPs also attended the courses with a view to use the methods in general practice. Thus, a significant effort has been made in order to enhance the use of Motivational interviewing in Denmark. However, no research on the effect of this effort has so far been attempted. 3

The ADDITION-study The ADDITION-study, Anglo-Danish-Ducth study of intensive treatment in people with screendetected diabetes in primary care was developed and implemented in cooperation between the Department of General Practice and the Steno Diabetes Centre. The ADDITION-study investigates the effects of screening and intensive treatment, including poly-pharmacological treatment and behaviour change, in patients with Type 2 diabetes in general practice (as shown in Figure 1, Appendix A) 13. The ADDITION-study includes Type 2 diabetes patients detected by screening treated by a target-driven approach to intensive treatment including behavioural change and it has a follow-up period of 5 years. It is a large-scale study in general practice of a highly prevalent disease. The ADDITION-study is an ongoing study encompassing three countries, The Netherlands, England and Denmark. In Denmark, the study is represented in five counties, Aarhus, Copenhagen, Ringkoebing, Ribe and South Jutland counties. In this thesis effect of Motivational interviewing was evaluated in a cluster-randomised controlled trial carried out in the counties of Aarhus and Copenhagen, Denmark, 2001. This PhD thesis is a part of the ADDITION-study. It specifically explores the effect after one year of Motivational interviewing on newly diagnosed Type 2 diabetes patients detected by screening. This thesis focuses on whether GPs using Motivational interviewing can increase adherence to and effect of intensive treatment of Type 2 diabetes patients risk profile, thus reaching treatment goals. Aim of PhD thesis The overall aim of this PhD thesis was to evaluate the effect of a course in Motivational interviewing on intensive treatment of Type 2 diabetes patients detected by screening in general practice. Furthermore, the PhD study aimed at evaluating: 1. The effectiveness of Motivational Interviewing as an intervention tool in previous randomised controlled clinical trials (RCT) and to identify factors shaping outcomes in the areas reviewed. 2. In which way a 1½-day course in Motivational interviewing and subsequent follow-up meetings influenced the GPs professional behaviour. 3. If the GPs having participated in a course in Motivational interviewing found the method applicable and useful in general practice. 4. If Motivational Interviewing in general practice can improve patients a) contemplation and readiness to change behaviour, b) their actual change in patient behaviour, and c) their beliefs about Type 2 diabetes treatment. 5. If a course in Motivational interviewing for GPs can improve the risk profile of Type 2 diabetes patients detected by screening. 4

Chapter 2 Motivational interviewing: a systematic review and meta-analysis. Rubak S, Sandbaek A, Lauritzen T, Christensen B. British Journal of General Practice. Accepted 2004. 5

Abstract Background: Motivational Interviewing is a well-known, scientifically tested method of client counselling developed by Miller and Rollnick and viewed as a useful intervention strategy in treatment of lifestyle behaviour and disease. Study design: A systematic review and a meta-analysis of randomized controlled trials (RTCs) using Motivational Interviewing as intervention. The aim is to evaluate the effectiveness of Motivational Interviewing in different areas of disease and to identify factors shaping outcomes. Methods: A systematic literature search in 16 databases produced after selection criteria 72 RCTs, the first published in 1991. A quality assessment was made with a validated scale. A meta-analysis was performed as a generic inverse variance meta-analysis. Results: Meta-analysis showed significant effect (95% CI) of Motivational Interviewing for combined effect estimates for Body Mass Index (BMI), total serum-cholesterol, systolic blood pressure, blood alcohol concentration, standard ethanol content, while combined effect estimates for cigarettes per day and for HbA1c were non-significant. Motivational Interviewing had significant and clinically relevant effect in app. 3 out of 4 studies with equal effect on biological (72%) and psychological diseases (75%). Psychologists and medical doctors obtained an effect in app. 80% of the studies, while other health care providers obtained an effect in 46% of the studies. When using Motivational Interviewing in brief encounters of 15 min., 64% of the studies showed effect. More than one encounter with the patient ensures effect of Motivational Interviewing. Conclusion: We conclude that Motivational Interviewing in a scientific setting outperforms traditional advice giving in the treatment of a broad range of behavioural problems and diseases. We now need large scale studies to prove, that Motivational Interviewing can be implemented into daily clinical work in primary and secondary health care. 6

Introduction The concept of Motivational Interviewing evolved from experience with treatment of alcoholism, and was first described by Miller in 1983 3. This basic experience was developed into a coherent theory and detailed description of clinical procedures is provided by Miller and Rollnick (1991) 1, who defined Motivational Interviewing as a directive, client-centred counselling style for eliciting behaviour change by helping clients to explore and resolve ambivalence. Miller and Rollnick s theory also draws inspiration from Carl Rogers work on non-directive counselling described in 1953 4. The examination and resolution of ambivalence is the central purpose in nondirective counselling, and the counsellor is intentionally directive in pursuing this goal. Motivational Interviewing is a particular way of helping clients recognize and do something about their present or potential problems. It is viewed as particularly useful with clients who are reluctant to change or ambivalent about changing their behaviour. The strategies of Motivational Interviewing are more persuasive than coercive, more supportive than argumentative, and the overall goal is to increase the client s intrinsic motivation so that change arises from within rather than being imposed from without 2. The spirit of Motivational Interviewing is captured in the key points in Appendix 1 2. Appendix 1. Miller & Rollnick: Characteristics of the motivational interviewing 1. Motivational Interviewing relies upon identifying and mobilizing the client's intrinsic values and goals to stimulate behaviour change. 2. Motivation to change is elicited from the client and not imposed from without. 3. Motivational Interviewing are designed to elicit, clarify, and resolve ambivalence to perceive benefits and costs associated with it. 4. Readiness to change is not a client trait, but a fluctuating product of interpersonal interaction. 5. Resistance and "denial" is often a signal to modify motivational strategies. 6. Eliciting and reinforcing the client s belief in ability to carry out and succeed in achieving a specific goal is essential. 7. The therapeutic relationship is a partnership with respect of client autonomy. 8. Motivational Interviewing is both a set of techniques and counselling style. 9. Motivational Interviewing is directive and client-centred counselling understanding and eliciting behaviour change. Motivational Interviewing is broadly applicable in the management of diseases which to some extent is associated with behaviour 6-77. It has been used and evaluated in relation to alcohol abuse, addiction to drugs, smoking cessation, weight-loss, adherence to treatment and follow-up, increase of physical activity, asthma treatment and diabetes treatment, Motivational Interviewing has been deployed by various health care providers, including, among others, psychologist, doctors, nurses and midwifes 6;8;30;38;54;62. This review provides an overview of the areas in which Motivational Interviewing has been applied. The aim of this review is to evaluate the effectiveness of Motivational Interviewing as an intervention tool in randomised controlled clinical trials (RCT) and to identify factors shaping outcomes in the areas reviewed. 7

Methods Search strategy The following electronic libraries were searched according to the Cochrane Collaboration s search strategy for randomised controlled trials for each database: the Cochrane Central Register of Controlled Trials on the Cochrane Library (issue 4, 2002); MEDLINE (1966 to January, 2004); EMBASE (1974 to January, 2004); and PsychINFO, including PsychLIT (1967 to January, 2004), Cancerlit (1966 to January, 2004), Science Direct/ISI, including scisearch and social scisearch (1972 to January, 2004), Sociological abstracts (1963 to January, 2004), social services abstracts (1980 to January, 2004), EBSCO net research databases (1980 to January, 2004), CSA/Econ lit index (1969 to January, 2004), Biological science (1982 to January, 2004), Biological abstracts (1969 to January, 2004), AIDS and cancer research abstracts (1982 to January, 2004), AskERIC (1966 to January, 2004), BIOSIS PREVIEWS (1969 to January, 2004), ABI-/INFORM (1971 to January, 2004). The following search terms were used for MEDLINE and adapted for each other database: motivational interviewing, motivational behaviour, behaviour/motivational interviewing, Behaviour change, Motivational change and Behaviour change/motivational interviewing. The proceedings of conferences during 1997 to 2004 on diabetes (American Diabetes Association, Diabetes UK [formerly British Diabetic Association], European Association for the Study of Diabetes, International Diabetes Federation) were searched under psychological, educational, or behavioural headings for reports of any trials using motivational interviewing. The reference lists of included studies and reviews were searched for additional studies. If an included trial did not supply sufficient data needed for the meta-analysis, we tried to obtain data approaching the authors and the same time asking for data from unpublished trials. The search process was performed by first author. Figure 1 shows the progress of RCTs through the review. 8