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Posttraumatic Stress Disorder and Childhood Traumatic Loss: A Secondary Analysis of Symptom Severity and Treatment Outcome.
Unterhitzenberger, J, Sachser, C, Rosner, R
Journal of traumatic stress. 2020;(3):208-217
Abstract
Loss is a commonly experienced traumatic event among children. Although the experience of loss can potentially lead to posttraumatic stress symptoms (PTSS), little is known about PTSS levels after traumatic loss versus other traumatic events. We investigated data from a randomized controlled trial (RCT) on trauma-focused cognitive behavioral therapy (TF-CBT) versus a waitlist condition for children with PTSS. In a secondary analysis, we compared participants who reported traumatic loss as their index event (n = 23) to those who reported the two most frequently reported index events in the RCT: sexual abuse (SA; n = 59) and physical violence (PV; n = 55). The index event was rated according to the participants' most distressing traumatic event reported on the Clinician-Administered PTSD Scale for Children and Adolescents. Participants who experienced traumatic loss reported fewer PTSS and better general functioning than those who reported SA. A subgroup RCT (n = 19) revealed TF-CBT to be highly effective in reducing PTSS in cases of traumatic loss, d = 1.69. The effect sizes for PTSS indicated that all three trauma groups benefited from TF-CBT. In the waitlist group, PTSS symptoms improved for SA and PV, ds = 0.76 and 0.98, respectively, but not for traumatic loss, d = 0.23. These findings suggest that TF-CBT is a feasible and promising treatment for children who experience PTSS after traumatic loss. The results are limited by the post hoc quality of the analyses and lack of a measure of grief in the RCT.
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Dysglycemia among youth with type 1 diabetes and suboptimal glycemic control in the Flexible Lifestyle Empowering Change trial.
Kahkoska, AR, Crandell, J, Driscoll, KA, Kichler, JC, Seid, M, Mayer-Davis, EJ, Maahs, DM
Pediatric diabetes. 2019;(2):180-188
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Abstract
OBJECTIVE To examine the prevalence and correlates of non-severe hypoglycemia among adolescents with type 1 diabetes and suboptimal glycemic control, an understudied topic in this group. METHODS Seven days of blinded continuous glucose monitor data were analyzed in 233 adolescents at baseline of the Flexible Lifestyle Empowering Change trial (13-16 years, type 1 diabetes duration >1 year, and hemoglobin A1c [HbA1c] 8-13% [64-119 mmol]). Incidence of clinical hypoglycemia (54-69 mg/dL) and clinically serious hypoglycemia (<54 mg/dL) was defined as number of episodes ≥15 minutes. Logistic regression modeling was used to determine the correlates of long duration of hypoglycemia, categorized by median split among those who experienced hypoglycemia. RESULTS The sample was 76.1% non-Hispanic white, 49.8% female, age = 14.9 ± 1.1 years, diabetes duration = 6.4 ± 3.7 years, and HbA1c = 9.6 ± 1.2% (81 ± 13 mmol/mol). Over 7 days, 79.4% of youth experienced ≥1 hypoglycemic episodes of <70 mg/dL, and 55.4% of youth experienced ≥1 hypoglycemic episodes of <54 mg/dL. Among all adolescents, the median duration of clinical hypoglycemia and clinically serious hypoglycemia was 21.9 (range 0-250.2) and 4.3 (range 0-209.7) minutes/day, respectively. Long duration of clinical hypoglycemia (range 1.8-17.4% time overall) and clinically serious hypoglycemia (range 1.2-14.6% time overall) was associated with older age and decreasing HbA1c. Long duration of clinically serious hypoglycemia also was associated with insulin pump use. CONCLUSIONS Almost 80% of adolescents with elevated HbA1c had an episode of clinical hypoglycemia, and >50% had clinically serious hypoglycemia in a week. Increased education alongside access to emerging diabetes technologies may help to prevent hypoglycemia while improving glycemic control.
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Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03).
Britton, B, Baker, AL, Wolfenden, L, Wratten, C, Bauer, J, Beck, AK, McCarter, K, Harrowfield, J, Isenring, E, Tang, C, et al
International journal of radiation oncology, biology, physics. 2019;(2):353-362
Abstract
PURPOSE Malnutrition in head and neck cancer (HNC) treatment is common and associated with poorer morbidity and mortality outcomes. This trial aimed to improve nutritional status during radiation therapy (RT) using a novel method of training dietitians to deliver psychological techniques to improve nutritional behaviors in patients with HNC. METHODS AND MATERIALS This trial used a stepped-wedge, randomized controlled design to assess the efficacy of the Eating As Treatment (EAT) program. Based on motivational interviewing and cognitive behavioral therapy, EAT was designed to be delivered by oncology dietitians and integrated into their clinical practice. During control steps, dietitians provided treatment as usual, before being trained in EAT and moving into the intervention phase. The training was principles based and sought to improve behavior-change skills rather than provide specific scripts. Patients recruited to the trial (151 controls, 156 intervention) were assessed at 4 time points (the first and the final weeks of RT, and 4 and 12 weeks afterward). The primary outcome was nutritional status at the end of RT as measured by the Patient-Generated Subjective Global Assessment. RESULTS Patients who received the EAT intervention had significantly better scores on the primary outcome of nutritional status at the critical end-of-treatment time point (β = -1.53 [-2.93 to -.13], P = .03). Intervention patients were also significantly more likely than control patients to be assessed as well-nourished at each time point, lose a smaller percentage of weight, have fewer treatment interruptions, present lower depression scores, and report a higher quality of life. Although results were not statistically significant, patients who received the intervention had fewer and shorter unplanned hospital admissions. CONCLUSIONS This trial is the first of its kind to demonstrate the effectiveness of a psychological intervention to improve nutrition in patients with HNC who are receiving RT. The intervention provides a means to ameliorate malnutrition and the important related outcomes and consequently should be incorporated into standard care for patients receiving RT for HNC.
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Parental support in promoting children's health behaviours and preventing overweight and obesity - a long-term follow-up of the cluster-randomised healthy school start study II trial.
Norman, Å, Zeebari, Z, Nyberg, G, Elinder, LS
BMC pediatrics. 2019;(1):104
Abstract
BACKGROUND Effects of obesity prevention interventions in early childhood are only meaningful if they are sustained over time, but long-term follow-up studies are rare. The school-based cluster-randomised Healthy School Start (HSS) trial aimed at child health promotion and obesity prevention through parental support was carried out in 31 pre-school classes (378 families) in disadvantaged areas in Sweden during 2012-2013. Post-intervention results showed intervention effects on intake of unhealthy foods and drinks, and lower BMI-sds in children with obesity at baseline. This study aimed to evaluate the long-term effectiveness 4 years post-intervention. METHODS Data were collected from 215 children in March-June 2017. Child dietary intake, screen time, and physical activity were measured through parental-proxy questionnaires. Child height and weight were measured by the research group. Group effects were examined using Poisson, linear, logistic, and quantile regression for data on different levels. Analyses were done by intention to treat, per protocol, and sensitivity analyses using multiple imputation. RESULTS No between-group effects on dietary intake, screen time, physical activity, or BMI-sds were found for the entire group at the four-year follow-up. In girls, a significant subgroup-effect was found favouring intervention compared to controls with a lower intake of unhealthy foods, but this was not sustained in the sensitivity analysis. In boys, a significant sub-group effect was found where the boys in the intervention group beyond the 95th percentile had significantly higher BMI-sds compared to boys in the control group. This effect was sustained in the sensitivity analysis. Analyses per protocol showed significant intervention effects regarding a lower intake of unhealthy foods and drinks in the children with a high intervention dose compared to controls. CONCLUSIONS Four years after the intervention, only sub-group effects were found, and it is unlikely that the HSS intervention had clinically meaningful effects on the children. These results suggest that school-based prevention programmes need to be extended for greater long-term effectiveness by e.g. integration into school routine practice. In addition, results showed that children with a high intervention dose had better long-term outcomes compared to controls, which emphasises the need for further work to increase family engagement in interventions. TRIAL REGISTRATION ISRCTN, ISRCTN39690370, retrospectively registered March 1, 2013, http://www.isrctn.com/ISRCTN39690370 .
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The Effect of a 2-Year Intervention Consisting of Diet, Physical Exercise, Cognitive Training, and Monitoring of Vascular Risk on Chronic Morbidity-the FINGER Randomized Controlled Trial.
Marengoni, A, Rizzuto, D, Fratiglioni, L, Antikainen, R, Laatikainen, T, Lehtisalo, J, Peltonen, M, Soininen, H, Strandberg, T, Tuomilehto, J, et al
Journal of the American Medical Directors Association. 2018;(4):355-360.e1
Abstract
OBJECTIVE To verify whether a multidomain intervention lowers the risk of developing new chronic diseases in older adults. METHODS Multicenter, double-blind randomized controlled trial started in October 2009, with 2-year follow-up. A total of 1260 people aged 60 to 77 years were enrolled in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). Participants were randomly assigned in a 1:1 ratio to a 2-year multidomain intervention (n = 631) (nutritional guidance, exercise, cognitive training, and management of metabolic and vascular risk factors) or a control group (n = 629) (general health advice). Data on most common chronic diseases were collected by a physician at baseline and 2 years later. RESULTS At 2-year follow-up, the average number of new chronic diseases was 0.47 [standard deviation (SD) 0.7] in the intervention group and 0.58 (SD 0.8) in the control group (P < .01). The incidence rate per 100 person-years for developing 1+ new disease(s) was 17.4 [95% confidence interval (CI) = 15.1-20.1] in the intervention group and 20.5 (95% CI = 18.0-23.4) in the control group; for developing 2+ new diseases, 4.9 (95% CI = 3.7-6.4) and 6.1 (95% CI = 4.8-7.8); and for 3+ new diseases, 0.7 (95% CI = 0.4-1.5) and 1.8 (95% CI = 1.1-2.8), respectively. After adjustment for age, sex, education, current smoking, alcohol intake, and the number of chronic diseases at baseline, the intervention group had a hazard ratio ranging from 0.80 (0.66-0.98) for developing 1+ new chronic disease(s) to 0.38 (0.16-0.88) for developing 3+ new chronic diseases compared to the control group. CONCLUSIONS Findings from this randomized controlled trial suggest that a multidomain intervention could reduce the risk of developing new chronic diseases in older people.
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Self-Efficacy and Pressure Ulcer Prevention After Spinal Cord Injury-Results From a Nationwide Community Survey in Switzerland (SwiSCI).
Hug, K, Stumm, C, Debecker, I, Fellinghauer, CS, Peter, C, Hund-Georgiadis, M
PM & R : the journal of injury, function, and rehabilitation. 2018;(6):573-586
Abstract
BACKGROUND Pressure ulcers (PUs) are a common and severe health condition in persons with spinal cord injury (SCI). Skin-care strategies for PU prevention are usually provided during initial rehabilitation. However, individuals with SCI often do not perform these strategies continuously, especially after discharge. The influence of psychological factors such as general self-efficacy (GSE) on the performance of PU prevention behavior has not yet been sufficiently explored. OBJECTIVE To investigate whether persons with greater levels of GSE are more likely to perform skin-care strategies for PU prevention regularly. DESIGN Nationwide cross-sectional survey within the Swiss Spinal Cord Injury Cohort Study. SETTING Community setting, data collection between 2011 and 2013. PARTICIPANTS A total of 456 subjects with a traumatic or nontraumatic SCI living in Switzerland. METHODS Associations between GSE and PU prevention behavior were analyzed by multivariate proportional odds regression models, including potential sociodemographic, lesion-related, and lifestyle-related confounders without and with interaction terms between GSE and potential effect modifiers. MAIN OUTCOME MEASUREMENTS Self-efficacy was assessed by the GSE scale comprising 10 items. PU preventive behavior was operationalized using 5 items of an adapted version of the Spinal Cord Injury Lifestyle scale. Both measurements were components of a self-administered questionnaire. RESULTS Based on the regression model without interaction terms, GSE levels were not associated with skin-care PU prevention. After we included interaction terms, the final model showed statistically significant associations between GSE and 3 skin-care items with odds ratios ranging from 1.09 to 1.17 (all P < .001). The slightly positive effect of GSE on PU prevention behavior was restricted to persons who sustained their SCI at a younger age. CONCLUSIONS GSE was generally not associated with skin-care PU prevention behavior among persons with SCI in this study. In further research, it might be of interest to assess SCI-specific concepts of self-efficacy. LEVEL OF EVIDENCE III.
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Randomized Controlled Trial of E-Counseling for Hypertension: REACH.
Nolan, RP, Feldman, R, Dawes, M, Kaczorowski, J, Lynn, H, Barr, SI, MacPhail, C, Thomas, S, Goodman, J, Eysenbach, G, et al
Circulation. Cardiovascular quality and outcomes. 2018;(7):e004420
Abstract
BACKGROUND The efficacy of internet-based interventions to improve hypertension management is not established. We evaluated the therapeutic benefit of e-counseling by adapting best evidence guidelines for behavioral counseling. METHODS AND RESULTS This multicenter double-blind randomized controlled trial included assessments at baseline, 4 months, and 12 months. Participants were 35 to 74 years of age and diagnosed with hypertension: systolic/diastolic blood pressure (BP) 130 to 180/85 to 110 mm Hg. BP was assessed by automated office measurement. E-Counseling used multimedia and interactive tools to increase motivation and skill for self-care (exercise, diet, medication adherence, and smoking cessation). Control used self-care education. Frequency of contact by our e-platform was equal for both trial arms. Primary end points were change at 4 and 12 months in systolic BP, diastolic BP, pulse pressure, total lipoprotein cholesterol, low-density lipoprotein cholesterol, total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio, non-high-density lipoprotein cholesterol, and Framingham 10-year cardiovascular risk index. Intention-to-treat analysis used generalized linear models adjusted for baseline measures, sex, and medications. Among 264 participants, mean age was 57.6 years (SE, 0.6), 58% were women, with 83% on antihypertensive medications. At 12 months, e-counseling versus control evoked greater reduction in systolic BP (-10.1 mm Hg [95% confidence interval (CI), -12.5, -7.6] versus -6.0 mm Hg [95% CI, -8.5, -3.5]; P=0.02); pulse pressure (-5.2 mm Hg [95% CI, -6.9, -3.5] versus -2.7 mm Hg [95% CI, -4.5, -0.9]; P=0.04), and Framingham risk index (-1.9% [95% CI, -3.3, -0.5] versus -0.02% [95% CI, -1.2, 1.7]; P=0.02), respectively. Among males in e-counseling versus control, 12-month end points included lower diastolic BP (P=0.01), non-high-density lipoprotein cholesterol (P=0.04), total lipoprotein cholesterol (P=0.03), and a trend for total lipoprotein cholesterol/high-density lipoprotein cholesterol ratio (P=0.07). CONCLUSIONS To our knowledge, this is the first double-blind randomized trial of e-counseling for hypertension. Added benefit for medical therapy was achieved by combining available technology with a clinically organized protocol of motivational and cognitive-behavioral counseling. CLINICAL TRIAL REGISTRATION https://www.clinicaltrials.gov; Unique identifier: NCT01541540.
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Superwellness Program: a cognitive-behavioral therapy-based group intervention to reduce weight gain in patients treated with antipsychotic drugs.
Magni, LR, Ferrari, C, Rossi, G, Staffieri, E, Uberti, A, Lamonaca, D, Boggian, I, Merlin, S, Primerano, G, Mombrini, A, et al
Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999). 2017;(3):244-251
Abstract
OBJECTIVE To assess the effectiveness of a cognitive-behavioral therapy-based intervention (Superwellness Program) on weight gain compared with a treatment-as-usual (TAU) approach in patients treated with antipsychotics, and to evaluate the relationship between body mass index (BMI) variation and clinical variables. METHOD Eighty-five patients treated with antipsychotics were allocated across two groups, experimental (n=59) and control (n=26). The Superwellness Program (experimental group) consisted of 32 twice-weekly 1-hour sessions, conducted by a psychologist and a nutritionist/nurse, concurrently with moderate food intake and moderate physical activity plans. Sociodemographic, clinical, and biological variables were collected at baseline, at the end of intervention (16 weeks), and after 6 months. RESULTS BMI change from baseline differed significantly between the experimental and control groups, with a larger decrease in the experimental group (F = 5.5, p = 0.021). Duration of illness moderated the effect of treatment on BMI (p = 0.026). No significant (p = 0.499) effect of intervention during the follow-up period was found. Interestingly, the intervention indirectly induced a significant (p = 0.024) reduction in metabolic risk by reducing BMI. CONCLUSION A cognitive-behavioral therapy-based intervention could be useful in reducing weight in a clinical population taking antipsychotics, with consequent benefit to physical and mental health.
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Early Therapeutic Alliance, Treatment Retention, and 12-Month Outcomes in a Healthy Lifestyles Intervention for People with Psychotic Disorders.
Andrews, M, Baker, AL, Halpin, SA, Lewin, TJ, Richmond, R, Kay-Lambkin, FJ, Filia, SL, Castle, D, Williams, JM, Clark, V, et al
The Journal of nervous and mental disease. 2016;(12):894-902
Abstract
Engaging and retaining individuals with psychotic disorders in psychosocial treatments is difficult. Early therapeutic alliance, treatment retention, and 12-month outcomes were examined in a subsample of smokers with a psychotic disorder (N = 178) participating in a healthy lifestyles study comparing a telephone versus face-to-face delivered intervention. Therapeutic alliance was assessed using the Agnew Relationship Measure; primary outcomes were treatment retention and changes in symptoms and health behaviors. Contrary to expectations, early alliance did not predict treatment retention. However, elements of both client- and therapist-rated alliance predicted some clinical outcomes (e.g., higher confidence in the therapeutic alliance at session 1 predicted improvements in 12-month depression). Some modest interactions between early alliance and intervention condition were also identified (e.g., clients initially with lower self-perceived initiative, or higher therapist-perceived bonding benefited preferentially from the telephone-delivered intervention), highlighting the need to further examine the interplay between therapeutic alliance and treatment modality.
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Empowering Parents of Obese Children (EPOC): A randomized controlled trial on additional long-term weight effects of parent training.
Warschburger, P, Kroeller, K, Haerting, J, Unverzagt, S, van Egmond-Fröhlich, A
Appetite. 2016;:148-156
Abstract
Although inpatient lifestyle treatment for obese children and adolescents can be highly effective in the short term, long-term results are unconvincing. One possible explanation might be that the treatment takes place far from parents' homes, limiting the possibility to incorporate the parents, who play a major role in establishing and maintaining a healthy lifestyle in childhood and adolescence. The main goal was to develop a brief behaviorally oriented parent training program that enhances 'obesity-specific' parenting skills in order to prevent relapse. We hypothesized that the inclusion of additional parent training would lead to an improved long-term weight course of obese children. Parents of obese children (n = 686; 7-13 years old) either participated in complementary cognitive-behavioral group sessions (n = 336) or received written information only (n = 350) during the inpatient stay. Children of both groups attended multidisciplinary inpatient rehabilitation. BMI-SDS as a primary outcome was evaluated at baseline, post-intervention and at 6- and 12-month follow-up. Intention-to-treat (ITT) as well as per-protocol analyses (PPA) were performed. A significant within-group decrease of 0.24 (95% CI 0.18 to 0.30) BMI-SDS points from the beginning of the inpatient stay through the first year was found, but no group difference at the one-year follow-up (mean difference 0.02; 95% CI -0.04 to 0.07). We also observed an increase in quality of life scores, intake of healthy food and exercise for both groups, without differences between groups (ITT and PPA). Thus, while the inpatient treatment proved highly effective, additional parent training did not lead to better results in long-term weight maintenance or to better psychosocial well-being compared to written psycho-educational material. Further research should focus on subgroups to answer the question of differential treatment effects.