Abstracts from the ICBM 2014 Meeting

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volving behavioral interventions to provide solutions for commonly encountered issues. ... Power point slides and selected read- ings will be distributed.
Int.J. Behav. Med. (2014) 21 (Suppl 1):S1–S216 DOI 10.1007/s12529-014-9418-2

ABSTRACTS

Abstracts from the ICBM 2014 Meeting

Workshop #1

Workshop #2

DESIGN AND CONDUCT OF RANDOMIZED BEHAVIORAL CLINICAL TRIALS – SESSION 1 Peter G. Kaufmann, Ph.D.1, Lynda H. Powell, Ph.D.2, Kenneth E. Freedland, Ph.D.3 1 National Heart, Lung and Blood Institute, Bethesda, Maryland 2 Rush University, Chicago, Illinois 3 Washington University, St. Louis, Missouri

USING N-OF-1 DESIGNS IN BEHAVIOURAL MEDICINE Prof Derek Johnston and Prof Marie Johnston Aberdeen University, Scotland

Introduction: Randomized controlled trials are the standard objective method for evaluating efficacy and effectiveness of interventions. Their implementation in behavioral medicine poses specific challenges that warrant careful consideration. Speakers will draw on their substantial experience in conducting, reviewing, and monitoring clinical trials involving behavioral interventions to provide solutions for commonly encountered issues. Objectives: this workshop is designed to provide a basic overview of the most salient principles that underlie the conduct of valid randomized behavioral clinical trials. Material will include a discussion of equipoise and blinding, efficacy and effectiveness, pragmatic trials, large simple trials, multisite trials, relationship of pilot studies to outcomes in the main trial, a consideration of Phases of trials, applicability of “Good Clinical Practices” as promulgated by regulatory agencies, issues in analysis including intent-to-treat, responder, and per-protocol analyses, primary and secondary endpoints, ancillary studies, and the structure and function of data and safety monitoring committees. Recognizing the diversity of issues in clinical trials, faculty will endeavor to integrate answers to specific questions or requests submitted to [email protected] not later than two weeks before the workshop. Altogether, this session will present the principal challenges associated with the design of clinical trials involving behavioral interventions, encourage questions from participants and encourage questions regarding any of the presented material. Workshop activities: The workshop will consist primarily of lectures, drawing on the contemporary clinical trials literature in behavioral medicine and related fields. Power point slides and selected readings will be distributed. We encourage questions submitted in advance of the workshop. The faculty will be available for consultation after the workshop. Description of the intended participants: The session assumes no particular level of familiarity with clinical trials involving behavioral interventions. It should be of interest to everyone with an interest in improving the quality of clinical research. Presenters: All three presenters have been involved in numerous single- and multi-site behavioral clinical trials involving individual or group-randomized designs, and have served on research grant review committees, data and safety monitoring boards, and taught clinical trials methods for more than a decade.

Introduction; N-of-1 studies (sometimes called single case studies) have been used for some time in clinical psychology, are increasingly used in medicine and have been advocated by the Medical Research Council in the UK as an important initial step developing and evaluating complex interventions. They are a critical aspect of testing that psychological theory applies to individuals. However n-of-1 studies are not common in behavioural medicine or health psychology perhaps because few researchers in these fields have been trained in the design, operationalisation and analysis n-of-1 studies. This workshop aims to modestly increase interested researchers’ and clinicians’ knowledge about n-of-1 and greatly increase their confidence that they can and should conduct n-of-1 research. Objectives; the objectives of this workshop are to consider: The importance of conducting n-of-1 studies in (a) the development and testing of theory, (b) the initial stages of treatment development and evaluation and (c) in clinical practice. The problems of establishing causality in n-of-1 studies and describe the main nof-1 designs that attempt to deal with this.The types of measures that can be used in n-of-1 studies including ecological momentary assessment/ experience sampling methods on PDAs, smart phones and similar devices. The main data analytic problems when analysing the time series data typical of n-of-1 studies in behavioural medicine. Current methods for understanding and analysing typical small sample n-of-1 data. Workshop activities; The workshop will include lectures, group discussion and demonstration of measurement and analytic procedures. Participants will be encouraged to describe their experience of n-of-1 methods and/or their future plans for n-of-1 studies. Description of the intended participants; The workshop is open to all with an interest in conducting n-of-1 studies. No previous experience of n-of-1 methods is required but some experience would be helpful. People with great expertise in n-of-1 methods might not gain much from the workshop, but we would surely gain from their attendance. Brief information on the presenters/facilitators Derek Johnston researches occupational stress, behavioural aspects of cardiovascular disease and physical activity. He has a particular interest in real time measurement of behaviour and physiological functioning and n-of-1 methodology. Marie Johnston conducts research on disability (theory, measurement and intervention) and on behaviour change in health and healthcare contexts using all appropriate methods including n-of-1 studies. Both are at

Int.J. Behav. Med. (2014) 21 (Suppl 1):S1–S216

Results: Intrinsic work motivation was related to preparatory as well as active job search behavior. Extrinsic work motivation was not related to any type of job search behavior. Work motivation was not related to reemployment. Active job search behavior was related to reemployment. Conclusion: Intrinsic motivation to work was predicting preparatory and active job search behavior and active job search behavior was important for getting reemployed. This study suggests that it is important to focus on job search strategies and not so much on financial incentives in supporting older unemployed to re-enter the labour market. CORRESPONDING AUTHOR: MSc. N Velterop, University Medical Center Groningen, The Netherlands, [email protected]

P26 TRENDS IN DEPRESSION AND WELL-BEING IN HUNGARIAN CANCER PATIENTS. A LONGITUDINAL STUDY E.K. Kallay1, D.L. Cs Degi L. Csaba1, K.M. Kopp Maria2, K.E. Kallay Eva1 1 Babes-Bolyai University, CLUJ-NAPOCA, Romania 2 Semmelweis University, BUDAPEST, Hungary Hungary has the highest rate of cancer-deaths in Europe, but longitudinal studies investigating psychosocial aspects of cancer-related distress are unknown. Our study aims to investigate major tendencies in cancer rate, trends in depression and well-being among Hungarian cancer patients. Our study is based on data obtained from Hungarostudy Epidemiological Panel, a nationally representative follow-up survey assessing healthrelated functioning in the Hungarian adult population. Self-report data were collected in three waves: 2002, 2006, 2013. Our results are based on the complete results of 2000 participants, assessing well-being (WHO-Well-being Index) and depression (Beck Depression Inventory). Statistical analyses used non-parametric tests. The number of diagnosed male cancer patients has significantly increased 2002-2006, and slightly decreased in 2013. In female participants, after the 2006 increase, cancer rates stagnated. After a significant increase from 2002 to 2006, depression decreased in male patients, while in female patients depression slightly decreased. In male participants well-being significantly decreased from 2002 to 2006, and than significantly increased in 2013. In female patients well-being constantly increased from 2002 to 2013. High cancer mortality rates were confirmed as significant factors associated with psychosocial burden of cancer. Depression contributes to adverse health effects over time, though cancer patients might counterbalance these effects with a “response shift”adaptation processes, reflected in favorable changes in subjective well-being. The practical value of our results consists in the delineation of tendencies, and identification of specific groups that may be more vulnerable to changing trends in cancer-distress. [Grant supported by CNCS - UEFISCDI (PN-II-RUTE2012-3-0011)]. CORRESPONDING AUTHOR: Lecturer EK Kallay, Babes-Bolyai University, Romania, [email protected]

P27 EFFECTS OF PSYCHOLOGICAL INOCULATION VERSUS SUPPORTIVE LISTENING ON OPTIMISM AND HOPELESSNESS IN BREAST CANCER PATIENTS Y. Gidron1, A.G. Gomes2, I.L. Leal2 1 Free University of Brussels (VUB), BRUSSELS, Belgium 2 ISPA, LISBON, Portugal Introduction: Studies have shown that helplessness accelerates tumors in animals and that helplessness-hopelessness (HH) predicts poor cancer prognosis in cancer patients. However, few studies tried to specifically

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reduce levels of HH in cancer patients. This study preliminarily tested the effects of “psychological inoculation”(PI) on implicit optimism and explicit HH. Methods: Portuguese women with breast cancer completed online measures of implicit optimism (a word-search task) and a scale of HH (from the mini-MAC), before and immediately after being randomized to view one of two brief films. In the implicit task, women had to find in 1min as many words as possible, where 5 were optimistic, 5 pessimistic. This scale previously predicted cancer survival. One film depicted a patient rejecting “challenging sentences”which reflected cognitive distortions underlying HH (PI film). The other film depicted the same patient speaking about her concerns and receiving supportive listening and empathy (control film). Results: The PI film led to significant increases in implicit optimism, while the control film led to significant reductions in explicit HH. Explicit HH was not correlated with implicit optimism scores in the present study. Conclusions: This study found preliminary evidence for the effects of PI on an indirect measure of optimism, and demonstrates the feasibility for possibly influencing patients’ psychological prognostic factors by merely viewing a PI-method film. The study also reveals the complexity of psychological assessment. Future studies need to test the long-term impact of these interventions and consider combining them to maximize effectiveness on reducing HH. CORRESPONDING AUTHOR: Prof. Y. Gidron, Free University of Brussels, (VUB), Belgium, [email protected]

P28 DEPRESSION AND ITS CORRELATES IN HUNGARIAN CANCER PATIENTS E.K. Kallay1, D.L. Cs Degi L Csaba1, K.E. Kallay Eva1, K.M. Kopp Maria2 1 Babes-Bolyai University, CLUJ-NAPOCA, Romania 2 Semmelweis University, BUDAPEST, Hungary The diagnosis and prolonged treatment with cancer have a profound impact on the patients’ life, which induce increased, debilitating levels of distress. Our study aims to investigate the major correlates of cancerinduced depression in Hungarian cancer patients. Our study is based on data obtained from the 2013 Hungarostudy Epidemiological Panel, a nationally representative follow-up survey assessing health-related functioning in the Hungarian adult population. Our results are based on the complete results of 2000 participants from the general population, 49 of which were diagnosed with different forms of cancer. We assessed demographic variables, depression (Beck Depression Inventory), well-being (WHO Well-being Index), sense of coherence, self-efficacy, and anomie. Statistical analyses used non-parametric tests. Our results indicate that in 2013 cancer patients were significantly more depressed, had significantly lower levels of well-being, and self efficacy than the general population. Within the group of cancer patients, we found strong positive correlations between depression and anomie, and strong negative correlations between depression and well-being, sense of coherence, self-efficacy. Regression analyses indicate that after controlling for age and gender, anomie, sense of coherence, self-efficacy and well-being explain 51% in the variance in depression within the group of cancer patients. Depression in cancer patients significantly impacts both the progression of the illness, and the quality of life of the patients. The practical value of our results consists in the identification of those areas of functioning where interventions may have positive effect. [Study was supported by CNCS - UEFISCDI (number PN-IIRUTE-2012-3-0011)]. CORRESPONDING AUTHOR: Lecturer EK Kallay, Babes-Bolyai University, Romania, [email protected]