The (cost-)effectiveness of combined lifestyle interventions for people with persistent low-back pain who are overweight or obese: A systematic review.

INTRODUCTION: Lifestyle factors are expected to contribute to the persistence and burden of low-back pain (LBP). However, there are no systematic reviews on the (cost-)effectiveness of combined lifestyle interventions for overweight or obese people with LBP. AIM: To assess whether combined lifestyle interventions are (cost-)effective for people with persistent LBP who are overweight or obese, based on a systematic review. DESIGN: Systematic review METHOD: PubMed, Cochrane, Embase, CINAHL, PsycINFO and the Wiley/Cochrane Library were searched from database inception till January 6th 2023. Two independent reviewers performed study selection, data-extraction and risk of bias scoring using the Cochrane RoB tool 2 and/or the Consensus Health Economic Criteria list. GRADE was used to assess the level of certainty of the evidence. RESULTS: In total 2510 records were screened, and 4 studies on 3 original RCTs with 216 participants were included. Low certainty evidence (1 study) showed that combined lifestyle interventions were not superior to usual care for physical functioning, pain and lifestyle outcomes. Compared to usual care, moderate certainty evidence showed that healthcare (-$292, 95%CI: 872; -33), medication (-$30, 95% CI -65; -4) and absenteeism costs (-$1000, 95%CI: 3573; -210) were lower for the combined lifestyle interventions. CONCLUSION: There is low certainty evidence from 3 studies with predominantly small sample sizes, short follow-up and low intervention adherence that combined lifestyle interventions are not superior to physical functioning, pain and lifestyle outcomes compared to usual care, but are likely to be cost-effective.

Evaluation of patient tissue selection methods for deriving equivalent density calibration for femoral bone quantitative CT analyses.

Osteoporosis affects an increasing number of people every year and patient specific finite element analysis of the femur has been proposed to identify patients that could benefit from preventative treatment. The aim of this study was to demonstrate, verify, and validate an objective process for selecting tissues for use as the basis of phantomless calibration to enable patient specific finite element analysis derived hip fracture risk prediction. Retrospective reanalysis of patient computed tomography (CT) scans has the potential to yield insights into more accurate prediction of osteoporotic fracture. Bone mineral density (BMD) specific calibration scans are not typically captured during routine clinical practice. Tissue-based BMD calibration can therefore empower the retrospective study of patient CT scans captured during routine clinical practice. Together the method for selecting tissues as the basis for phantomless calibration coupled with the post-processing steps for deriving a calibration equation using the selected tissues provide an estimation of quantitative equivalent density results derived using calibration phantoms. Patient tissues from a retrospective cohort of 211 patients were evaluated. The best phantomless calibration resulted in a femoral strength (FS) [N] bias of 0.069 ± 0.07% over FS derived from inline calibration and a BMD [kg/cm3] bias of 0.038 ± 0.037% over BMD derived from inline calibration. The phantomless calibration slope for the best method presented was within the range of patient specific calibration curves available for comparison and demonstrated a small bias of 0.028 ± 0.054 HU/(mg/cm3), assuming the Mindways Model 3 BMD inline calibration phantom as the gold standard. The presented method of estimating a calibration equation from tissues showed promise for CT-based femoral fracture analyses of retrospective cohorts without readily available calibration data.

The intervention process in the European Fans in Training (EuroFIT) trial: a mixed method protocol for evaluation.

BACKGROUND: EuroFIT is a gender-sensitised, health and lifestyle program targeting physical activity, sedentary time and dietary behaviours in men. The delivery of the program in football clubs, led by the clubs' community coaches, is designed to both attract and engage men in lifestyle change through an interest in football or loyalty to the club they support. The EuroFIT program will be evaluated in a multicentre pragmatic randomised controlled trial (RCT), for which ~1000 overweight men, aged 30-65 years, will be recruited in 15 top professional football clubs in the Netherlands, Norway, Portugal and the UK. The process evaluation is designed to investigate how implementation within the RCT is achieved in the various football clubs and countries and the processes through which EuroFIT affects outcomes. METHODS: This mixed methods evaluation is guided by the Medical Research Council (MRC) guidance for conducting process evaluations of complex interventions. Data will be collected in the intervention arm of the EuroFIT trial through: participant questionnaires (n = 500); attendance sheets and coach logs (n = 360); observations of sessions (n = 30); coach questionnaires (n = 30); usage logs from a novel device for self-monitoring physical activity and non-sedentary behaviour (SitFIT); an app-based game to promote social support for physical activity outside program sessions (MatchFIT); interviews with coaches (n = 15); football club representatives (n = 15); and focus groups with participants (n = 30). Written standard operating procedures are used to ensure quality and consistency in data collection and analysis across the participating countries. Data will be analysed thematically within datasets and overall synthesis of findings will address the processes through which the program is implemented in various countries and clubs and through which it affects outcomes, with careful attention to the context of the football club. DISCUSSION: The process evaluation will provide a comprehensive account of what was necessary to implement the EuroFIT program in professional football clubs within a trial setting and how outcomes were affected by the program. This will allow us to re-appraise the program's conceptual base, optimise the program for post-trial implementation and roll out, and offer suggestions for the development and implementation of future initiatives to promote health and wellbeing through professional sports clubs. TRIAL REGISTRATION: ISRCTN81935608 . Registered on 16 June 2015.

Impact of physical activity on fatigue and quality of life in people with advanced lung cancer: a randomized controlled trial.

BACKGROUND: Physical activity (PA) improves fatigue and quality of life (QOL) in cancer survivors. Our aim was to assess whether a 2-month PA intervention improves fatigue and QOL for people with advanced lung cancer. METHODS: Participants with advanced lung cancer, Eastern Cooperative Oncology Group performance status (PS) ≤2, >6 months life expectancy, and ability to complete six-min walk test, were stratified (disease stage, PS 0-1 versus 2, centre) and randomized (1:1) in an open-label study to usual care (UC) (nutrition and PA education materials) or experimental intervention (EX): UC plus 2-month supervised weekly PA and behaviour change sessions. Assessments occurred at baseline, 2, 4, and 6 months. The primary endpoint was fatigue [Functional Assessment of Cancer Therapy-Fatigue (FACT-F) questionnaire] at 2 months. The study was designed to detect a difference in mean FACT-F subscale score of 6. Analysis was intention-to-treat using linear mixed models. RESULTS: We recruited 112 patients: 56 (50.4%) were randomized to EX, 55(49.5%) to UC; 1 ineligible. Male 55%; median age 64 years (34-80); 106 (96%) non-small cell lung cancer; 106 (95.5%) stage IV. At 2, 4 and 6 months, 90, 73 and 62 participants were assessed, respectively, with no difference in attrition between groups. There were no significant differences in fatigue between the groups at 2, 4 or 6 months: mean scores at 2 months EX 37.5, UC 36.4 (difference 1.2, 95% CI - 3.5, 5.8, P = 0.62). There were no significant differences in QOL, symptoms, physical or functional status, or survival. CONCLUSIONS: Adherence to the intervention was good but the intervention group did not increase their PA enough compared to the control group, and no difference was seen in fatigue or QOL. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry No. ACTRN12609000971235.

A qualitative study of the anticipated barriers and facilitators to the implementation of a lifestyle intervention in the Dutch construction industry.

BACKGROUND: Lifestyle interventions have proven effective for lowering a cardiovascular risk profile by improving lifestyle behaviors, blood glucose and blood cholesterol levels. However, implementation of lifestyle interventions is often met with barriers. This qualitative study sought to determine anticipated barriers and facilitators to the nationwide implementation of an effective lifestyle intervention in the construction industry in the Netherlands. METHODS: Prior to implementation, focus groups were held with 8 lifestyle counselors and semi-structured interviews with 20 employees of the construction industry, 4 occupational physicians, 4 medical assistants, and 1 manager of an occupational health service. The transcripts were coded by two coders and analyzed by constant comparison. RESULTS: Hypothetical employee willingness to sign up for the intervention was facilitated by a high level of perceived risk, perceived added value of the intervention, and perceived social support. It was hampered by a preference for independence and perceived interference with their work. All professionals named a lack of time as an anticipated barrier to implementation. Lifestyle counselors suggested several strategies to improve the proficiency of their counseling technique, such as training in small groups and a continuous stream of employee referrals. Occupational physicians thought they would be hampered in screening employees and referring them to a lifestyle counselor by the perception that addressing employee lifestyles was not their task, and by a counter-productive relationship with other stakeholders. The manager addressed financial incentives and a good intervention fit with the current approach of the OHS. CONCLUSION: The findings suggest that employees can be motivated to sign up for a lifestyle intervention by tailoring the implementation strategy to various subgroups within the target group. Occupational physicians can be motivated to refer employees for the intervention by making a referral personally and professionally rewarding.

A mobile health intervention for weight management among young adults: a pilot randomised controlled trial.

BACKGROUND: Today's generation of young adults are gaining weight faster than their parents; however, there remains insufficient evidence to inform interventions to prevent this weight gain. Mobile phones are a popular means of communication that may provide a convenient, inexpensive means to deliver health intervention programmes. This pilot study aimed to measure the effect of a 12-week mobile health (mHealth) intervention on body weight, body mass index and specific lifestyle behaviours addressed by the programme. METHODS: University students and staff aged 18-35 years (n = 51) were randomised (ratio 1 : 1, intervention : control). Both groups received a printed diet booklet with instructions prepared by a dietitian. The intervention group also received Short Message Service (SMS) text messages (four per week), e-mails (four per week), and had access to smartphone applications and Internet forums. RESULTS: Pre- to post-intervention, participants in the intervention group decreased their body weight [mean (SD)] [-1.6 (2.6) kg], increased their light intensity activity [34 (35) min day(-1)] and reported an increased vegetable (1.0 median serving day(-1)) and decreased sugar-sweetened beverage intake [-355 (836) mL week(-1)]. Despite this, post-intervention changes in outcomes were not significantly different from controls. CONCLUSIONS: The piloted mHealth programme provided some short-term positive changes in weight, nutrition and physical activity using a low cost, convenient delivery method for this population. However, changes were no different from those observed among controls. This might partly be explained by intervention participants' low engagement with the programme, which is likely to require further modification to provide more regular, personalised, monitored support.

Determination of the translational and rotational stiffnesses of an L4-L5 functional spinal unit using a specimen-specific finite element model.

The knowledge of spinal kinematics is of paramount importance for many aspects of clinical application (i.e. diagnosis, treatment and surgical intervention) and for the development of new spinal implants. The aim of this study was to determine the translational and rotational stiffnesses of a functional spinal unit (FSU) L4-L5 using a specimen-specific finite element model. The results are needed as input data for three-dimensional (3D) multi-body musculoskeletal models in order to simulate vertebral motions and loading in the lumbar spine during daily activities. Within the modelling process, a technique to partition the constitutive members and to calibrate their mechanical properties for the complex model is presented. The material and geometrical non-linearities originating from the disc, the ligaments and the load transfer through the zygapophysial joints were considered. The FSU was subjected to pure moments and forces in the three anatomical planes. For each of the loading scenarios, with and without vertical and follower preload, the presented technique provides results in fair agreement with the literature. The novel representation of the nonlinear behaviour of the translational and rotational stiffness of the disc as a function of the displacement can be used directly as input data for multi-body models.

Comparison of the influences of structural characteristics on bulk mechanical behaviour: experimental study using a bone surrogate.

An experimental study was conducted to classify the influence of trabecular architecture and cortical shell thickness on the mechanical properties using a bone surrogate. Thirty-six rectangular prisms and 18 vertebral-shaped specimens were fabricated with fused deposition modelling (FDM) as a bone surrogate with controlled structural characteristics (cortical wall thickness, strut spacing, strut angle and strut orientation). The apparent density of the FDM specimens was evaluated using quantitative computed tomography (QCT) imaging and related to the apparent elastic modulus measured with compression testing. The effects of the structural parameters on the apparent elastic modulus were analysed using analysis of variance (ANOVA). The results obtained corroborate that the structural parameters have a significant effect on the apparent mechanical properties of the bulk material. The cortical shell thickness was found to have more influence than trabecular architecture. Therefore, accurate modelling of the cortical shell thickness should be considered more important than trabecular architecture in development of bone finite element models and bone surrogates.

Replicating interbody device subsidence with lumbar vertebraesurrogates.

Bone surrogates are proposed alternatives to human cadaveric vertebrae for assessing interbody device subsidence. A synthetic vertebra with representations of cortices, endplates and cancellous bone was recently developed as an alternative surrogate to polyurethane foam blocks. The ability of the two surrogates to replicate subsidence has not been fully assessed, and was evaluated by indenting them with ring-shaped indenters and comparing their performance with human cadaveric vertebrae using qualitative characteristics and indentation metrics. The sensitivity of each surrogate to a centrally or peripherally placed indenter was of particular interest. Many indentation characteristics of the foam blocks were similar to those of human cadaveric vertebrae, except their insensitivity to centrally and peripherally placed indenters, owing to their homogeneous mechanical properties. This is distinctly different from the cadaveric vertebrae, where a peripherally placed indenter indented significantly less than a centrally placed indenter, because of endplates. By contrast, the synthetic vertebra was sensitive to peripherally placed indenters owing to its bi-material composition, including a thickened peripheral endplate. However, an overly strong synthetic endplate resulted in unrepresentative indentation shape and depth. Both surrogates produced similar results to human cadaveric vertebrae in certain respects, but neither is accurate enough in terms of material property distribution to model subsidence completely in human cadaveric vertebrae.

A pilot structured behavioural intervention trial to increase physical activity among women with recent gestational diabetes.

Forty-three women were recruited into a 1-year randomised controlled trial to test the feasibility of a structured behavioural intervention to increase physical activity after gestational diabetes. Increases in achievement of physical activity targets were not attained. Recruitment and subject retention were identified as major challenges.

General practitioners' perceptions and practices of physical activity counselling: changes over the past 10 years.

OBJECTIVE: In this work, trends in general practitioners' (GP) knowledge, confidence and practices in promoting physical activity to patients over a 10-year period (1997-2007) were studied. DESIGN: Repeated cross-sectional population survey SETTING: General practice in New South Wales (Australia) PARTICIPANTS: 646 (40%), 747 (53%) and 511 (64%) GPs that were registered in a selection of urban and rural divisions in New South Wales participated in 2007, 2000 and 1997, respectively. MAIN OUTCOME MEASURES: Self-report questionnaire on the GP's knowledge, confidence, role perception, attendance of continuous professional development and counselling practice with regard to promoting physical activity in their patients were the main outcome measures. RESULTS: The majority of GPs felt confident in giving physical activity advice and saw it as their role to do so. The proportion of GPs with high confidence and role perception increased between 1997 and 2000 (p<0.001) but remained unchanged thereafter. In 1997, GPs were 0.54 times less likely (95% CI 0.42 to 0.69, p<0.001) to discuss physical activity with more than 10 patients per week than GPs in 2007. However, the percentage of new patients that were asked about their physical activity did not change over the last decade. CONCLUSIONS: Most increases in the proportion of GPs reporting high knowledge, role perception and confidence in giving physical activity advice to patients occurred between 1997 and 2000 and remained unchanged thereafter. In 2007, GPs appeared to give more physical activity advice, but Australian general practice is not yet living up to its potential with regard to physical activity promotion.

Cognitive behavioural therapy (CBT) compared with blood glucose awareness training (BGAT) in poorly controlled Type 1 diabetic patients: long-term effects on HbA moderated by depression. A randomized controlled trial.

OBJECTIVE: To test the effectiveness at 6 and 12 months' follow-up of group cognitive behavioural therapy (CBT) compared with blood glucose awareness training (BGAT) in poorly controlled Type 1 diabetic patients and to explore the moderating effect of baseline depression. RESEARCH DESIGN AND METHODS: Adults with Type 1 diabetes (n = 86) with glycated haemoglobin (HbA(1c)) >or= 8% were randomized to CBT or BGAT. Primary outcome was HbA(1c) control. Secondary outcomes were: self-care, diabetes-related distress (Problem Areas in Diabetes scale; PAID), diabetes self-efficacy (Confidence in Diabetes Self-care scale; CIDS) and depressive symptoms (Centre for Epidemiological Studies--Depression scale; CES-D). Measurements were scheduled before CBT and BGAT, and at 3, 6 and 12 months after. Differential effects were analysed for the subgroup of patients reporting low vs. high baseline levels of depression. RESULTS: Neither CBT nor BGAT had a significant impact on HbA(1c) at 6 and 12 months' follow-up. Both interventions resulted in lower depressive symptoms (CES-D 15.7-13.3, P = 0.01) up to 12 months, but only CBT was effective in lowering HbA(1c) in patients with high baseline depression scores (HbA(1c) 9.5-8.8%) up to 1 year of follow-up (P = 0.03). CONCLUSIONS: Our findings suggest that group CBT can effectively help Type 1 diabetic patients with co-morbid depression achieve and maintain better glycaemic outcomes.

[End-of-life decisions in seriously ill patients: the position of intensive care nurses]. / Beslissingen rond het levenseinde bij ernstig zieke patiënten: de plaats van intensivecareverpleegkundigen.

Intensive care units regularly have patients in whom a curative treatment plan is changed to palliative treatment. This does not only concern the medical and technical aspects, but also medical-ethical problems and questions relating to communication and organization. All these play a part in making a correct assessment. It is logical that nurses play an important part in this process as they have the most contact with the patient and his/her family. The optimalization of collaboration between doctors and nurses by means of the mutual exchange of information unique to each different discipline as well as acknowledging one another's talents and skills, forms the basis of good communication and organization concerning end-of-life decisions. It is useful to formalize this collaboration by means of multidisciplinary discussions.

[Mental and physical health problems of, and the use of healthcare by, Afghan, Iranian and Somali asylum seekers and refugees]. / Psychische en lichamelijke gezondheidsproblemen van en gebruik van zorg door Afghaanse, Iraanse en Somalische asielzoekers en vluchtelingen.

OBJECTIVE: To estimate the prevalence rates of mental and physical health problems and the use of healthcare services among adult asylum seekers and recognised refugees from Afghanistan, Iran and Somalia in the Netherlands. DESIGN: Cross-sectional study. METHOD: Asylum seekers were approached in 14 reception centres and refugees were interviewed in 3 municipalities (Arnhem, Leiden and Zaanstad). Respondents were interviewed in their own language and asked questions pertaining to: general health, chronic complaints, symptoms of post-traumatic stress disorder (PTSD), symptoms of depression/ anxiety, the use of healthcare services (general practitioner, medical specialists, hospitalisation, mental-health services, medication) and background variables. RESULTS: A total of 232 asylum seekers and 178 refugees participated (response rates of89% and 59%, respectively). Of these, 142 (61%) and 99 (56%), respectively were males and the average age was 34.4 (SD: 11.o) and 40.3 (SD: 13.3) years, respectively. Compared to refugees, asylum seekers more often considered their health to be poor (42% and 59%, respectively), had more symptoms of depression/anxiety (39% and 68%, respectively), and had more symptoms of PTSD (11% and 28%, respectively). No differences were found between refugees and asylum seekers in the self-reported use of healthcare services. CONCLUSION: This study showed that asylum seekers have more health problems than refugees, but that there are no differences in the self-reported use of healthcare services. More research is needed to answer the question ifasylum seekers have sufficient access to the healthcare system.

Proxy measurements in multiple sclerosis: agreement between patients and their partners on the impact of multiple sclerosis in daily life.

BACKGROUND: The use of self-report measurements in clinical settings has increased. The underlying assumption for self-report measurements is that the patient understands the questions fully and is able to give a reliable assessment of his or her own health status. This might be problematic in patients with limitations that interfere with reliable self-assessment such as cognitive impairment or serious mood disturbances, as may be the case in multiple sclerosis. In these situations proxies may provide valuable information, provided we can be certain that proxies and patients give consistent ratings. OBJECTIVE: To examine whether patients with multiple sclerosis and their partners agree on the impact of multiple sclerosis on the daily life of the patient by using the Multiple Sclerosis Impact Scale (MSIS-29). METHODS: 59 patients with multiple sclerosis and their partners completed the MSIS-29. Agreement was examined, comprehensively at scale score levels and item functioning, using both traditional and less conventional psychometric methods (Rasch analysis). RESULTS: Agreement between patients and partners was good for the physical scale, and slightly less but still adequate for the psychological scale. Mean directional differences did not show considerable systematic bias between patients and proxies. Intraclass correlation coefficients (ICCs) satisfied the requirements for agreement, but were higher for the physical scale (0.81) than for the psychological scale (0.72). These findings were supported by Rasch analyses. CONCLUSION: In this sample, albeit small, partners provided accurate estimates of the impact of multiple sclerosis. This supports the value of self-rating scales and indicates that partners might be useful sources of information when assessing the impact of multiple sclerosis on the daily life of patients.

Long term health complaints following the Amsterdam Air Disaster in police officers and fire-fighters.

BACKGROUND: On 4 October 1992, a cargo aircraft crashed into apartment buildings in Amsterdam, the Netherlands. Fire-fighters and police officers assisted with the rescue work. OBJECTIVES: To examine the long term health complaints in rescue workers exposed to a disaster. METHODS: A historical cohort study was performed among police officers (n = 834) and fire-fighters (n = 334) who performed at least one disaster related task and reference groups of their non-exposed colleagues (n = 634 and n = 194, respectively). The main outcome measures included digestive, cardiovascular, musculoskeletal, nervous system, airway, skin, post-traumatic stress, fatigue, and general mental health complaints; haematological and biochemical laboratory values; and urinalysis outcomes. RESULTS: Police officers and fire-fighters who were professionally exposed to a disaster reported more physical and mental health complaints, compared to the reference groups. No clinically relevant statistically significant differences in laboratory outcomes were found. CONCLUSIONS: This study is the first to examine long term health complaints in a large sample of rescue workers exposed to a disaster in comparison to reference groups of non-exposed colleagues. Findings show that even in the long term, and in the absence of laboratory abnormalities, rescue workers report more health complaints.

Counselling increases physical activity behaviour nine weeks after rehabilitation.

BACKGROUND: For people with disabilities, a physically active lifestyle can reduce the risk of secondary health problems and improve overall functioning. OBJECTIVES: To determine the effects of the sport stimulation programme "rehabilitation and sports" (R&S) and R&S combined with the daily physical activity promotion programme "active after rehabilitation" (AaR) on sport participation and daily physical activity behaviour nine weeks after inpatient or outpatient rehabilitation. METHODS: Subjects in four intervention rehabilitation centres were randomised to a group receiving R&S only (n = 315) or a group receiving R&S and AaR (n = 284). Subjects in six control rehabilitation centres (n = 603) received the usual care. Most common diagnoses were stroke, neurological disorders, and back disorders. Two sport and two daily physical activity outcomes were assessed with questionnaires seven weeks before and nine weeks after the end of rehabilitation. Data were analysed by intention to treat and on treatment multilevel analyses, comparing both intervention groups with the control group. RESULTS: The R&S group showed no significant change. Intention to treat analyses of the R&S+AaR group showed significant improvements in one sport (p = 0.02) and one physical activity outcome (p = 0.03). On treatment analyses in the R&S+AaR group showed significant improvements in both sport outcomes (p<0.01 and p = 0.02) and one physical activity outcome (p<0.01). CONCLUSIONS: Only the combination of R&S and AaR had increased sports participation and daily physical activity behaviour nine weeks after the end of inpatient or outpatient rehabilitation.

Psychometric evaluation of the multiple sclerosis impact scale (MSIS-29) for proxy use.

BACKGROUND: There may be difficulties in the use of self report measurements in patients with cognitive impairment or serious mood disturbances which interfere with reliable self assessment, as may be the case in multiple sclerosis (MS). In such cases proxies may provide valuable information. However, before using any questionnaires in a proxy sample, the questionnaire should be evaluated for proxy use. OBJECTIVE: To evaluate the psychometric properties of the 29 item Multiple Sclerosis Impact Scale (MSIS-29) when used by proxies of MS patients. METHODS: A sample of 62 partners of MS patients completed the MSIS-29. The data were evaluated for the psychometric criteria of the MSIS-29, including data quality, scaling assumptions, acceptability, reliability, validity, and responsiveness. RESULTS: Psychometric evaluation was satisfactory; data quality was high, and scaling assumptions and acceptability were good. Reliability was high (alpha>0.80). Findings were consistent with results of a psychometric evaluation in a patient sample. CONCLUSIONS: The MSIS-29 can be used reliably in proxies of patients with MS. As a next step the relation between data obtained from patients and proxies needs to be studied, focusing on factors that may affect agreement and discrepancies.

Short-term effects of cognitive behavioural group training (CBGT) in adult Type 1 diabetes patients in prolonged poor glycaemic control. A randomized controlled trial.

AIMS: To assess the effects of cognitive behavioural group training (CBGT) on glycaemic control, diabetes self-efficacy and well-being in Type 1 diabetes patients in persistent poor glycaemic control. METHODS: In a randomized controlled trial, a total of 107 patients with Type 1 diabetes in poor glycaemic control (HbA(1c) > or = 8%) were assigned to a 6-week CBGT or blood glucose awareness training (BGAT) as control condition. The intervention was preceded by a 3-month run-in period. Glycaemic control (HbA(1c)), diabetes-specific self-efficacy (CIDS), diabetes-related distress (PAID) and depressive symptoms (CES-D), were assessed at baseline (T1), directly before (T2) and 3 months after (T3) the intervention. RESULTS: No significant changes in HbA(1c) were found after CBGT, whilst diabetes self-efficacy increased (mean CIDS score 71.6 +/- 14.0 to 74.3 +/- 12.2) and diabetes-related distress (mean PAID score 47.0 +/- 21.6 to 42.6 +/- 20.8) and depressive symptoms decreased (mean CES-D score 16.9 +/- 12.8 to 13.5 +/- 12.6). Changes in psychological outcomes were similar for both treatment groups. Diabetes self-care behaviours improved equally. Drop-out rate, which was higher among CBGT participants, was relatively low overall (total n = 15, 17.05%), and both interventions were well-appreciated by the participants. CONCLUSIONS: CBGT was successful in improving self-efficacy, diabetes-related distress and mood at 3 months' follow-up, but not in improving glycaemic control.