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A Tailored Cognitive-Behavioural Intervention Produces Comparable Reductions in Regimen-Related Distress in Adults With Type 2 Diabetes Regardless of Insulin Use: 12-Month Outcomes From the COMRADE Trial.
Lutes, LD, Cummings, DM, Littlewood, K, Le, MT, Kirian, K, Patil, S, Solar, C, Carraway, M, Hambidge, B
Canadian journal of diabetes. 2020;(6):530-536
Abstract
OBJECTIVES Our aim in this study was to determine whether a cognitive-behavioural therapy plus small changes lifestyle intervention can produce comparable improvements in insulin users vs patients not using insulin with uncontrolled type 2 diabetes (T2D) and comorbid depressive or regimen-related distress (RRD) symptoms. METHODS This study is a secondary analysis of Collaborative Care Management for Distress and Depression in Rural Diabetes Study, a randomized, controlled trial of a 16-session, severity-tailored cognitive-behavioural therapy plus small changes lifestyle intervention compared with usual care. Outcomes included glycated hemoglobin (A1C), regimen-related distress, depression, medication adherence and diabetes self-care. Our investigation provides 2 sets of contrasts: 1) insulin users in the intervention group compared with insulin users in the usual-care group and 2) insulin users compared with noninsulin users in the intervention group only. RESULTS Of the 139 participants, 72 (52%) were using insulin at baseline and had significantly higher levels of A1C (10.2±2.1% vs 8.9±1.6%) and RRD (3.3±1.4 vs 2.8±1.1), and significantly poorer medication adherence (5.2±2.1 days/wk vs 5.5±1.7 days/wk). Intervention patients using insulin exhibited significantly greater reductions in RRD and marginally significant improvements in medication adherence and A1C compared with insulin users in usual care. Within the intervention group, changes in RRD, medication adherence and A1C did not differ significantly by insulin use. CONCLUSIONS Tailored cognitive-behavioural therapy with a small-changes lifestyle intervention improved elevated RRD and A1C outcomes at least as effectively in insulin users as non‒insulin users. Future powered studies need to address the role of insulin use in uptake and treatment outcomes.
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Psychological distress following a motor vehicle crash: preliminary results of a randomised controlled trial investigating brief psychological interventions.
Guest, R, Tran, Y, Gopinath, B, Cameron, ID, Craig, A
Trials. 2018;(1):343
Abstract
BACKGROUND The preliminary results of a randomised controlled trial are presented. The aim of the trial is to determine the efficacy, feasibility and acceptability of email-delivered psychological interventions with telephone support, for adults injured in a motor vehicle crash engaged in seeking compensation. The primary intention for this preliminary analysis was to investigate those who were psychologically distressed and to stop the trial midway to evaluate whether the safety endpoints were necessary. METHODS The analysis included 90 adult participants randomised to one of three groups, who were assessed at baseline and post-intervention at 3 months. Cognitive behaviour therapy (CBT) or healthy lifestyle interventions were delivered over 10 weeks, involving fortnightly emailed modules plus clinically focussed telephone support, with the aim of reducing psychological distress. An active waiting list of control subjects received non-clinically focussed telephone contact over the same period along with claim-related reading material. Depression Anxiety Stress Scales (DASS) and Impact of Events Scale (Revised) (IES-R) were used to assess psychological distress. Psychiatric interviews were used to diagnose major depressive disorder and post-traumatic stress disorder. Aspects of acceptability and feasibility were also assessed. RESULTS For those diagnosed with depression at baseline in the CBT group, psychological distress reduced by around 16%. For those with depression in the healthy lifestyle group, distress increased marginally. For those in the control group with depression, distress also decreased (by 18% according to DASS-21 and 1.2% according to IES-R). For those without depression, significant reductions in distress occurred, regardless of group (P < .05). The results suggest that for those with depression, a healthy lifestyle intervention is contraindicated, necessitating the cessation of recruitment to this intervention. The interventions were reported as acceptable by the majority and the data indicated that the study is feasible. CONCLUSIONS CBT with telephone support reduced psychological distress in physically injured people with depression who are engaged in seeking compensation. However, time plus fortnightly telephone contact with claim-related reading material may be sufficient to reduce distress in those who are depressed. For those who were not depressed, time plus telephone support is most likely sufficient enough to assist them to recover. The trial will continue with further recruitment to only the CBT and control groups, over longer follow-up periods. TRIAL REGISTRATION Australian and New Zealand Clinical Trials Registry: Preventing psychological distress following a motor vehicle accident; ACTRN12615000326594 . Registered on 9 April 2015.
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The PED-t trial protocol: The effect of physical exercise -and dietary therapy compared with cognitive behavior therapy in treatment of bulimia nervosa and binge eating disorder.
Mathisen, TF, Rosenvinge, JH, Pettersen, G, Friborg, O, Vrabel, K, Bratland-Sanda, S, Svendsen, M, Stensrud, T, Bakland, M, Wynn, R, et al
BMC psychiatry. 2017;(1):180
Abstract
BACKGROUND Sufferers from bulimia nervosa (BN) and binge eating disorder (BED) underestimate the severity risk of their illness and, therefore, postpone seeking professional help for years. Moreover, less than one in five actually seek professional help and only 50% respond to current treatments, such as cognitive behavioral therapy (CBT). The impetus for the present trial is to explore a novel combination treatment approach adapted from physical exercise- and dietary therapy (PED-t). The therapeutic underpinnings of these separate treatment components are well-known, but their combination to treat BN and BED have never been previously tested. The purpose of this paper is to provide the rationale for this new treatment approach and to outline the specific methods and procedures. METHODS The PED-t trial uses a prospective randomized controlled design. It allocates women between 18 and 40 years (BMI range 17.5-35.0) to groups consisting of 5-8 members who receive either CBT or PED-t for 16 weeks. Excess participants are allocated to a waiting list control group condition. All participants are assessed at baseline, post-treatment, 6, 12 and 24 months' post-follow-up, respectively, and monitored for changes in biological, psychological and therapy process variables. The primary outcome relates to the ED symptom severity, while secondary outcomes relates to treatment effects on physical health, treatment satisfaction, therapeutic alliance, and cost-effectiveness. We aim to disseminate the results in high-impact journals, preferable open access, and at international conferences. DISCUSSION We expect that the new treatment will perform equal to CBT in terms of behavioral and psychological symptoms, but better in terms of reducing somatic symptoms and complications. We also expect that the new treatment will improve physical fitness and thereby, quality of life. Hence, the new treatment will add to the portfolio of evidence-based therapies and thereby provide a good treatment alternative for females with BN and BED. TRIAL REGISTRATION Prospectively registered in REC the 16th of December 2013 with the identifier number 2013/1871 , and in Clinical Trials the 17th of February 2014 with the identifier number NCT02079935 .
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Cognitive-Behavioural Therapy for Inflammatory Bowel Disease: 24-Month Data from a Randomised Controlled Trial.
Mikocka-Walus, A, Bampton, P, Hetzel, D, Hughes, P, Esterman, A, Andrews, JM
International journal of behavioral medicine. 2017;(1):127-135
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PURPOSE There is ongoing controversy on the effectiveness of psychotherapy in inflammatory bowel disease (IBD). In the few small studies, cognitive-behavioural therapy (CBT) has been shown to alleviate symptoms of anxiety or depression. However, there is little research on the impact of CBT on physical outcomes in IBD and no studies on long-term effectiveness of CBT. METHODS The present two-arm pragmatic randomised controlled trial aimed to establish the impact of CBT on disease course after 24 months of observation. The study compared standard care plus CBT (+CBT) with standard care alone (SC). CBT was delivered over 10 weeks, face-to-face (F2F) or online (cCBT). The data were analysed using linear mixed-effects models. RESULTS CBT did not significantly influence disease activity as measured by disease activity indices at 24 months (Crohn's Disease Activity Index (CDAI), p = 0.92; Simple Clinical Colitis Activity Index (SCCAI), p = 0.88) or blood parameters (C-reactive protein (CRP), p < 0.62; haemoglobin (Hb), p = 0.77; platelet, p = 0.64; white cell count (WCC), p = 0.59) nor did CBT significantly affect mental health, coping or quality of life (all p > 0.05). CONCLUSIONS Therefore, we conclude that CBT does not influence the course of IBD over 24 months. Given the high rate of attrition, particularly in the CBT group, future trials should consider a personalised approach to psychotherapy, perhaps combining online and one-to-one therapist time.
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Prevention of the development of psychological distress following a motor vehicle crash: study protocol for a randomized controlled trial.
Guest, R, Tran, Y, Gopinath, B, Cameron, ID, Craig, A
Trials. 2016;(1):317
Abstract
BACKGROUND It is estimated that up to 50 % of motor vehicle crash survivors develop significant psychological distress, such as depressive mood and anxiety, within 6 months of the crash. Associated impacts include loss of employment, delayed return to work, financial and familial stress, and increased medical and compensation costs. The major aim of this research is to investigate the efficacy of interventions for preventing the development of psychological distress following a motor vehicle crash. The efficacy of two brief interventions will be examined: a cognitive behaviour therapy (CBT) programme, targeting mood and anxiety, and a lifestyle programme, targeting sleep, diet and physical activity. METHODS/DESIGN This is a randomized, controlled multisite study. Participants include at least 180 adults injured in a motor vehicle crash who have entered a compensation process. Research will compare outcomes in three groups randomly assigned to: one group of 60 adults, who receive a brief email-delivered CBT programme, with one session every 2 weeks for 10 weeks and telephone contact every 2 weeks; a second group of 60 adults, who receive a brief email-delivered lifestyle intervention involving one session every 2 weeks for 10 weeks with telephone contact; and an active waiting-list control group of 60 adults who are provided claims processing-related reading material along with telephone contact every 2 weeks for 10 weeks. Participants will be recruited within 12 weeks of the motor vehicle crash, and will be comprehensively assessed before and after treatment, and 6 and 12 months post-injury. Assuming an α probability level of 0.05 and a power of 80 %, at least 180 participants will be recruited. The primary outcome measure is the presence and severity of psychological distress or disorder. Secondary outcome measures include assessment of self-efficacy, resilience employment status, social activity and support, lifestyle and physical health factors, along with process outcome measures of treatment acceptability, feasibility and generalizability. DISCUSSION This study will determine whether brief email-delivered interventions distributed soon after the injury and entry into the claims process can be effective in preventing the development of psychological distress. TRIAL REGISTRATION ANZCTR, ACTRN12615000326594 . Registered on 9 April 2015.
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High or low intensity text-messaging combined with group treatment equally promote weight loss maintenance in obese adults.
Zwickert, K, Rieger, E, Swinbourne, J, Manns, C, McAulay, C, Gibson, AA, Sainsbury, A, Caterson, ID
Obesity research & clinical practice. 2016;(6):680-691
Abstract
BACKGROUND Text-message and e-mail are emerging as potential methods for improving weight outcomes among obese individuals. The optimal volume, frequency, and timing of such interventions are unknown. This study investigated the effect of adjunct technological support on weight and psychological variables after a 3-month cognitive-behaviour therapy (CBT) group intervention. METHODS Sixty obese adults were randomised to a CBT programme plus intensive (text-message and e-mail; CBT+ITS) or minimal (text-message only; CBT+MTS) technological support. Assessments occurred at baseline, 3-, 6-, 9-, and 15-months. Outcome variables included weight (kg), body mass index (kg/m2), waist circumference (cm), binge-eating tendencies, weight self-efficacy, and weight control cognitions and behaviours. RESULTS CBT+ITS (n=31) and CBT+MTS (n=29) participants lost 5.2% (±1.1) and 4.7% (±1.1) of their baseline weight by 3-months, 8.4% (±1.2) and 6.4% (±1.1) by 6-months, 9.6% (±1.3) and 6.4% (±1.3) by 9-months, and sustained a 7.5% (±1.3) and 5.1% (±1.3) loss at 15-months, respectively. There were no significant differences between intensive and minimal support, however, the CBT+ITS group showed a marginal advantage across all anthropometric measures. CONCLUSIONS A low intensity text-message support programme is just as effective as higher intensity technological support for maintaining weight loss in obese adults. This represents a low-cost means of aiding weight loss maintenance without reliance on extended face-to-face treatment.
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The Maintaining Musculoskeletal Health (MAmMOTH) Study: Protocol for a randomised trial of cognitive behavioural therapy versus usual care for the prevention of chronic widespread pain.
Macfarlane, GJ, Beasley, M, Prescott, G, McNamee, P, Keeley, P, Artus, M, McBeth, J, Hannaford, P, Jones, GT, Basu, N, et al
BMC musculoskeletal disorders. 2016;:179
Abstract
BACKGROUND Cognitive behavioural therapy (CBT) has been shown to improve outcomes for patients with fibromyalgia, and its cardinal feature chronic widespread pain (CWP). Prediction models have now been developed which identify groups who are at high-risk of developing CWP. It would be beneficial to be able to prevent the development of CWP in these people because of the high cost of symptoms and because once established they are difficult to manage. We will test the hypothesis that among patients who are identified as at high-risk, a short course of telephone-delivered CBT (tCBT) reduces the onset of CWP. We will further determine the cost-effectiveness of such a preventative intervention. METHODS The study will be a two-arm randomised trial testing a course of tCBT against usual care for prevention of CWP. Eligible participants will be identified from a screening questionnaire sent to patients registered at general practices within three Scottish health boards. Those returning questionnaires indicating they have visited their doctor for regional pain in the last 6 months, and who have two of, sleep problems, maladaptive behaviour response to illness, or high number of somatic symptoms, will be invited to participate. After giving consent, participants will be randomly allocated to either tCBT or usual care. We aim to recruit 473 participants to each treatment arm. Participants in the tCBT group will have an initial assessment with a CBT therapist by telephone, then 6 weekly sessions, and booster sessions 3 and 6 months after treatment start. Those in the usual care group will receive no additional intervention. Follow-up questionnaires measuring the same items as the screening survey questionnaire will be sent 3, 12 and 24 months after start of treatment. The main outcome will be CWP at the 12 month questionnaire. DISCUSSION This will be the first trial of an intervention aimed at preventing fibromyalgia or CWP. The results of the study will help to inform future treatments for the prevention of chronic pain, and aetiological models of its development. TRIAL REGISTRATION ClinicalTrials.gov ID: NCT02668003URL: Please check that the following URLs are working. If not, please provide alternatives: NCT02668003Alternative is: https://www.clinicaltrials.gov/ct2/show/NCT02668003> . Date registered: 28-Jan-2016.
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Improved sleep quality in older adults with insomnia reduces biomarkers of disease risk: pilot results from a randomized controlled comparative efficacy trial.
Carroll, JE, Seeman, TE, Olmstead, R, Melendez, G, Sadakane, R, Bootzin, R, Nicassio, P, Irwin, MR
Psychoneuroendocrinology. 2015;:184-92
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IMPORTANCE Sleep disturbances have been linked to increased morbidity and mortality, yet it is unknown whether improving sleep quality in older adult patients with insomnia alters biomarkers of diabetes and cardiovascular disease risk. OBJECTIVE Determine the comparative efficacy of cognitive behavioral therapy (CBT), tai chi chih (TCC), and a sleep seminar control (SS) to reduce multisystem biomarkers of disease risk in older adults with insomnia. DESIGN Randomized controlled comparative efficacy trial. SETTING Los Angeles community. PARTICIPANTS A population-based sample of 109 older adults with chronic and primary insomnia. INTERVENTION Random assignment to CBT, TCC, or SS for 2-h group sessions weekly over 4 months with a 16-month evaluation (1 year after follow-up). MAIN OUTCOME(S) AND MEASURE(S): Multisystem biological risk comprised of 8 biomarkers: high-density lipoprotein, low-density lipoprotein, triglycerides, hemoglobinA1c, glucose, insulin, C-reactive protein, and fibrinogen. Using clinical laboratory cutoffs defined as abnormal, a multisystem risk score was computed representing a sum of the deviation around the cutoffs across the 8 biomarkers. In addition, high risk grouping was classified if subjects exhibited 4 or more biomarkers in the abnormal laboratory range. RESULTS An interaction of time-by-treatment-by-high risk group was found (F(4, 197.2)=3.14, p=.02) in which both TCC (p=.04) and CBT (p=.001) showed significantly lower risk scores as compared to SS at 16-months. CBT reduced risk of being in the high risk group at 4-months (odds ratio [OR]=.21 [95% CI, .03-1.47], p<.10) and at 16-months (OR=.06 [95% CI, .005-.669]; p<.01). TCC reduced the risk at 16-months (OR=.10 [95% CI, .008-1.29]; p<.05) but not at 4 months. Of participants who were classified in the high risk category at baseline, improvements in sleep quality, as defined by a clinical severity threshold, reduced the likelihood of being in the high risk group at 16-months, OR=.08 (95% CI, .008-.78); p=.01. CONCLUSIONS AND RELEVANCE Participants classified as having high multisystem biological risk at entry and assigned to CBT or TCC show improvements in risk scores after one year follow-up. Given that these clinical biomarkers are associated with cardiovascular, metabolic, and inflammatory disease risk, improving sleep quality has the potential to reduce the risk of chronic disease in older adults with insomnia. Clinical Trial Registration # and name—ClinicalTrials.gov: NCT00280020, Behavioral Treatment of Insomnia in Aging
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Cognitive-behavioral treatment reduces attrition in treatment-resistant obese women: results from a 6-month nested case-control study.
Tagliabue, A, Repossi, I, Trentani, C, Ferraris, C, Martinelli, V, Vinai, P
Neuro endocrinology letters. 2015;(4):368-73
Abstract
OBJECTIVE The aim of this nested case-control study was to compare the effectiveness of cognitive-behavioral treatment (CBT) for treatment-resistant obese (body mass index [BMI] ≥ 30 kg/m²) women compared with standard dietary treatment. The main outcome measures were attrition and weight loss success. METHODS We designed a 6-month case-control study, nested within a cohort of adult (age ≥ 18 years) treatment-resistant (history of at least two previous diet attempts) obese women. Cases were 20 women who were offered CBT sessions. Controls (n=39) were randomly selected from the source population and matched to cases in terms of baseline age, BMI, and number of previous diet attempts. RESULTS Compared with controls, cases were significantly more likely to complete the 6-month program in both age-adjusted (odds ratio [OR]=2.94, 95% confidence interval [CI]=1.05-8.97) and multivariate-adjusted (OR=2.77, 95% CI=1.02-8.34) analyses. In contrast, cases were not more likely to achieve weight loss success in age-adjusted (OR=1.32, 95% CI=0.86-1.67) and multivariate-adjusted (OR=1.21, 95% CI=0.91-1.44) analyses. CONCLUSIONS Compared with a standard dietary treatment, CBT was significantly more effective in reducing attrition in treatment-resistant obese women, without differences in terms of weight loss success.
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Reasoning Exercises in Assisted Living: a cluster randomized trial to improve reasoning and everyday problem solving.
Williams, K, Herman, R, Bontempo, D
Clinical interventions in aging. 2014;:981-96
Abstract
PURPOSE OF THE STUDY Assisted living (AL) residents are at risk for cognitive and functional declines that eventually reduce their ability to care for themselves, thereby triggering nursing home placement. In developing a method to slow this decline, the efficacy of Reasoning Exercises in Assisted Living (REAL), a cognitive training intervention that teaches everyday reasoning and problem-solving skills to AL residents, was tested. DESIGN AND METHODS At thirteen randomized Midwestern facilities, AL residents whose Mini Mental State Examination scores ranged from 19-29 either were trained in REAL or a vitamin education attention control program or received no treatment at all. For 3 weeks, treated groups received personal training in their respective programs. RESULTS Scores on the Every Day Problems Test for Cognitively Challenged Elders (EPCCE) and on the Direct Assessment of Functional Status (DAFS) showed significant increases only for the REAL group. For EPCCE, change from baseline immediately postintervention was +3.10 (P<0.01), and there was significant retention at the 3-month follow-up (d=2.71; P<0.01). For DAFS, change from baseline immediately postintervention was +3.52 (P<0.001), although retention was not as strong. Neither the attention nor the no-treatment control groups had significant gains immediately postintervention or at follow-up assessments. Post hoc across-group comparison of baseline change also highlights the benefits of REAL training. For EPCCE, the magnitude of gain was significantly larger in the REAL group versus the no-treatment control group immediately postintervention (d=3.82; P<0.01) and at the 3-month follow-up (d=3.80; P<0.01). For DAFS, gain magnitude immediately postintervention for REAL was significantly greater compared with in the attention control group (d=4.73; P<0.01). IMPLICATIONS REAL improves skills in everyday problem solving, which may allow AL residents to maintain self-care and extend AL residency. This benefit is particularly important given the growing population of AL residents at risk for cognitive and self-care decline.