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The Effects of Computerized Cognitive Training With and Without Physical Exercise on Cognitive Function in Older Adults: An 8-Week Randomized Controlled Trial.
Ten Brinke, LF, Best, JR, Chan, JLC, Ghag, C, Erickson, KI, Handy, TC, Liu-Ambrose, T
The journals of gerontology. Series A, Biological sciences and medical sciences. 2020;(4):755-763
Abstract
BACKGROUND Aging is characterized by cognitive changes in specific domains, such as declines in memory and executive functions. Given the world's aging population, it is important to identify and evaluate strategies that promote healthy cognitive aging. Besides exercise, computerized cognitive training (CCT) is a promising approach to promote cognitive function. Moreover, a single bout of exercise immediately prior to CCT may provide additional cognitive benefits. METHODS An 8-week proof-of-concept randomized controlled trial to investigate the effect of a commercial CCT intervention, alone and when preceded by exercise, on cognitive function. Participants (124; aged 65-85 years) performed 8 weeks of: (i) Group-based CCT (Fit Brains) 3×/week for 1 hour plus 3×/week home-based training; (ii) Group-based CCT preceded by exercise (Ex-CCT) 3×/week for 1 hour plus 3×/week home-based training (exercise+CCT); or (iii) Group-based balanced and toned (BAT) classes 3×/week for 1 hour (control). Memory was assessed by the Rey Auditory Verbal Learning Test. Executive functions were assessed using the: (i) Stroop Test, (ii) Trail Making Tests (TMT), (iii) Flanker Test, and (iv) Dimensional Change Card Sort Test (DCCS). RESULTS At trial completion, there were no significant between-group differences in memory (p > .05). However, compared with BAT, CCT, and Ex-CCT significantly improved Stroop performance (-10.72, 95% confidence interval [CI]: -16.53, -4.91; -7.95, 95% CI: -13.77, -2.13, respectively). Moreover, Ex-CCT significantly improved the performance on TMT (-13.65, 95% CI: -26.09, -1.22), the Flanker Test (6.72, 95% CI: 2.55, 10.88), and the DCCS Test (6.75, 95% CI: 0.99, 12.50). CONCLUSION An 8-week CCT program may promote executive functions in older adults and combining it with a bout of exercise may provide broader benefits.
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Are Dilated Fundus Examinations Needed for OCT-Guided Retreatment of Exudative Age-Related Macular Degeneration?
Patel, Y, Miller, DM, Fung, AE, Hill, LF, Rosenfeld, PJ
Ophthalmology. Retina. 2020;(2):141-147
Abstract
PURPOSE To determine whether presence of macular hemorrhage on dilated fundus examination (DFE) or fundus photography influences vision outcomes with OCT-guided pro re nata (PRN) ranibizumab retreatment in patients with neovascular age-related macular degeneration (nAMD), we investigated whether hemorrhage without OCT-detectable fluid impacted vision outcomes. DESIGN Post hoc analysis of prospectively collected data from the 24-month pHase III, double-masked, multicenter, randomized, Active treatment-controlled study of the efficacy and safety of 0.5 mg and 2.0 mg Ranibizumab administered monthly or on an as-needed Basis (PRN) in patients with subfoveal neOvascular age-related macular degeneration (HARBOR) trial (ClinicalTrials.gov identifier, NCT00891735). PARTICIPANTS This post hoc analysis examined 1097 patients from the intention-to-treat population of HARBOR. METHODS Dilated fundus examination and fundus photography were evaluated for hemorrhage, and spectral-domain (SD) OCT images from HARBOR participants were analyzed for macular fluid secondary to macular neovascularization. Agreement between methods was determined for each time point. Visual outcomes were evaluated for 82 patients with evidence of hemorrhage on DFE or fundus photography at 3 months and no evidence of SD-exudative activity requiring retreatment at month 3. MAIN OUTCOME MEASURES Pooled data from the intention-to-treat population of HARBOR were analyzed for hemorrhage on DFE or fundus photography and exudative activity on SD OCT. A subgroup of PRN patients were analyzed for best-corrected visual acuity gains at 24 months. RESULTS Most study eyes (89% [973/1095]) showed macular hemorrhages at baseline, declining to 31% (319/1042) at month 3 and stabilizing at 11% (111/989) by month 6 of follow-up. After baseline, exudative activity was detected on SD-OCT in more than 89% of eyes when hemorrhage was present on DFE or fundus photography. Patients not requiring a month 3 PRN ranibizumab injection achieved similar visual gains over 24 months, regardless of month 3 hemorrhage presence versus absence: 9.4 and 8.7 Early Treatment Diabetic Retinopathy Study letter scores, respectively (P = 0.74). CONCLUSIONS After 3 initial ranibizumab injections, SD-OCT detected nAMD activity in 89% of eyes when hemorrhage was present on fundus photography. Ranibizumab retreatment guided by monthly SD-OCT achieved similar vision gains with or without injection when hemorrhage was present without OCT-detectable fluid. This suggests that macular hemorrhages without OCT-detectable macular fluid may not require treatment and DFE may not be needed at every visit. These conclusions should be confirmed in a prospective randomized trial before firm recommendations regarding clinical practice can be made.
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Efficacy of an internet-based exposure treatment for flying phobia (NO-FEAR Airlines) with and without therapist guidance: a randomized controlled trial.
Campos, D, Bretón-López, J, Botella, C, Mira, A, Castilla, D, Mor, S, Baños, R, Quero, S
BMC psychiatry. 2019;(1):86
Abstract
BACKGROUND Internet-based treatments appear to be a promising way to enhance the in vivo exposure approach, specifically in terms of acceptability and access to treatment. However, the literature on specific phobias is scarce, and, as far as we know, there are no studies on Flying Phobia (FP). This study aims to investigate the effectiveness of an Internet-based exposure treatment for FP (NO-FEAR Airlines) that includes exposure scenarios composed of images and sounds, versus a waiting-list control group. A secondary aim is to explore two ways of delivering NO-FEAR Airlines, with and without therapist guidance. METHODS A randomized controlled trial (RCT) was conducted in which 69 participants were allocated to: 1) NO-FEAR Airlines totally self-applied, 2) NO-FEAR Airlines with therapist guidance, 3) a waiting-list control group. Primary outcome measures were the Fear of Flying Questionnaire-II and the Fear of Flying Scale. Secondary outcomes included the Fear and Avoidance Scales, Clinician Severity Scale, and Patient's Improvement scale. Behavioral outcomes (post-treatment flights and safety behaviors) were also included. Mixed-model analyses with no ad hoc imputations were conducted for primary and secondary outcome measures. RESULTS NO-FEAR Airlines (with and without therapist guidance) was significantly effective, compared to the waiting list control group, on all primary and secondary outcomes (all ps < .05), and no significant differences were found between the two ways of delivering the intervention. Significant improvements on diagnostic status and reliable change indexes were also found in both treatment groups at post-treatment. Regarding behavioral outcomes, significant differences in safety behaviors were found at post-treatment, compared to the waiting list. Treatment gains were maintained at 3- and 12-month follow-ups. CONCLUSION FP can be treated effectively via the Internet. NO-FEAR Airlines helps to enhance the exposure technique and provide access to evidence-based psychological treatment to more people in need. These data are congruent with previous studies highlighting the usefulness of computer-assisted exposure programs for FP, and they contribute to the literature on Internet-based interventions. To the best of our knowledge, this is the first RCT to investigate the effectiveness of an Internet-based treatment for FP and explore two ways of delivering the intervention (with and without therapist guidance). TRIAL REGISTRATION Clinicaltrials.gov: NCT02298478 ( https://clinicaltrials.gov/ct2/show/NCT02298478 ). Trial registration date 3 November 2014.
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Computer-Guided Problem-Solving Treatment for Depression, PTSD, and Insomnia Symptoms in Student Veterans: A Pilot Randomized Controlled Trial.
Bedford, LA, Dietch, JR, Taylor, DJ, Boals, A, Zayfert, C
Behavior therapy. 2018;(5):756-767
Abstract
Depression is a highly prevalent psychological disorder experienced disproportionately by college student military veterans with many deleterious effects including risk for suicide. Treatment can help, but the debilitating nature of depression often makes seeking in-person treatment difficult and many are deterred by stigma, inconvenience, concerns about privacy, or a preference to manage problems themselves. The current study examines the efficacy of a computer-guided Problem-Solving Treatment (ePST®) for reducing symptoms of depression, posttraumatic stress disorder (PTSD), and insomnia in student military veterans. Twenty-four student veterans (Meanage = 32.7) with symptoms of depression were randomly assigned either to a treatment group receiving six weekly sessions of ePST or to a minimal contact control group (MCC). Participants completed the Patient Health Questionnaire-9 (PHQ-9) depression scale at baseline and then weekly through post-ePST or post-MCC. PTSD and insomnia questionnaires were also completed at baseline and posttreatment. A linear mixed model regression showed a statistically significant Group (ePST vs. MCC) × Time (pretreatment through posttreatment) interaction for depression, with the ePST showing substantial improvements in depressive symptoms over the 6-week period. Significant improvements were also seen in PTSD and insomnia symptoms. Results suggest that ePST can effectively treat depression, PTSD, and insomnia symptoms in student military veterans and may be a viable alternative for those who are not able to access live therapy. Future work should examine the durability of treatment effects and utility for more severe depression and suicide prevention.
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Adherence of stroke patients with an online brain training program: the role of health professionals' support.
Wentink, MM, Meesters, J, Berger, MAM, de Kloet, AJ, Stevens, E, Band, GPH, Kromme, CH, Wolterbeek, R, Goossens, PH, Vliet Vlieland, TPM
Topics in stroke rehabilitation. 2018;(5):359-365
Abstract
Background Computer-based cognitive rehabilitation is used to improve cognitive functioning after stroke. However, knowledge on adherence rates of stroke patients is limited. Objective To describe stroke patients' adherence with a brain training program using two frequencies of health professionals' supervision. Methods This study is part of a randomized controlled trial comparing the effect of the brain training program (600 min playtime with weekly supervision) with a passive intervention in patients with self-perceived cognitive impairments after stroke. Patients randomized to the control condition were offered the brain training after the trial and received supervision twice (vs weekly in intervention group). Adherence was determined using data from the study website. Logistic regression analyses were used to examine the impact of supervision on adherence. Results 53 patients allocated to the intervention group (group S8; 64% male, mean age 59) and 52 patients who were offered the intervention after the trial (group S2; 59% male, mean age 59) started the brain training. The median playtime was 562 min (range 63-1264) in group S8 vs. 193 min (range 27-2162) in group S2 (p < 0.001, Mann Whitney U). Conclusions The overall adherence of stroke patients with a brain training was low and there are some implications that systematic, regular interaction with a supervisor can increase training adherence of stroke patients with a restitution-focused intervention performed at home.
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Mediterranean Diet Adherence and Genetic Background Roles within a Web-Based Nutritional Intervention: The Food4Me Study.
San-Cristobal, R, Navas-Carretero, S, Livingstone, KM, Celis-Morales, C, Macready, AL, Fallaize, R, O'Donovan, CB, Lambrinou, CP, Moschonis, G, Marsaux, CFM, et al
Nutrients. 2017;(10)
Abstract
Mediterranean Diet (MedDiet) adherence has been proven to produce numerous health benefits. In addition, nutrigenetic studies have explained some individual variations in the response to specific dietary patterns. The present research aimed to explore associations and potential interactions between MedDiet adherence and genetic background throughout the Food4Me web-based nutritional intervention. Dietary, anthropometrical and biochemical data from volunteers of the Food4Me study were collected at baseline and after 6 months. Several genetic variants related to metabolic risk features were also analysed. A Genetic Risk Score (GRS) was derived from risk alleles and a Mediterranean Diet Score (MDS), based on validated food intake data, was estimated. At baseline, there were no interactions between GRS and MDS categories for metabolic traits. Linear mixed model repeated measures analyses showed a significantly greater decrease in total cholesterol in participants with a low GRS after a 6-month period, compared to those with a high GRS. Meanwhile, a high baseline MDS was associated with greater decreases in Body Mass Index (BMI), waist circumference and glucose. There also was a significant interaction between GRS and the MedDiet after the follow-up period. Among subjects with a high GRS, those with a high MDS evidenced a highly significant reduction in total carotenoids, while among those with a low GRS, there was no difference associated with MDS levels. These results suggest that a higher MedDiet adherence induces beneficial effects on metabolic outcomes, which can be affected by the genetic background in some specific markers.
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Self-care tools to treat depressive symptoms in patients with age-related eye disease: a randomized controlled clinical trial.
Kamga, H, McCusker, J, Yaffe, M, Sewitch, M, Sussman, T, Strumpf, E, Olivier, S, Wittich, W, Moghadaszadeh, S, Freeman, EE
Clinical & experimental ophthalmology. 2017;(4):371-378
Abstract
BACKGROUND Depression is very common in people with age-related eye disease. Our goal was to determine if self-care tools plus limited telephone support could reduce depressive symptoms in patients with age-related macular degeneration or diabetic retinopathy. DESIGN A single-blind randomized controlled clinical trial was conducted at Maisonneuve-Rosemont Hospital in Montreal, Canada. PARTICIPANTS Eighty participants were recruited. METHODS To be eligible, participants must have had either late stage age-related macular degeneration or diabetic retinopathy, at least mild depressive symptoms, and visual acuity better than 20/200. Half were randomized to the intervention arm and half to delayed intervention/usual care. The intervention consisted of large print written and audio tools incorporating cognitive-behavioral principles plus three 10-minute telephone calls from a lay coach. Eight-week follow-up data were collected by telephone. MAIN OUTCOME MEASURES The primary outcome was the 8-week change in depressive symptoms as measured by the Patient Health Questionnaire-9. Secondary outcomes included anxiety, life space and self-efficacy. RESULTS The baseline mean logMAR visual acuity was 0.37 (SD = 0.20), and the baseline mean Patient Health Questionnaire-9 score was 9.5 (SD = 3.9) indicating moderate depressive symptoms. After adjusting for baseline imbalances in visual acuity, the intervention reduced depressive symptoms by 2.1 points more than usual care (P = 0.040). The intervention was not associated with the secondary outcomes (P > 0.05). CONCLUSIONS Self-care tools plus telephone coaching led to a modest improvement in depressive symptoms in patients with age-related eye disease. Additional research on how to maximize their effect is necessary.
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Do images of a personalised future body shape help with weight loss? A randomised controlled study.
Ossolinski, G, Jiwa, M, McManus, A, Parsons, R
Trials. 2017;(1):180
Abstract
BACKGROUND This randomised controlled study evaluated a computer-generated future self-image as a personalised, visual motivational tool for weight loss in adults. METHODS One hundred and forty-five people (age 18-79 years) with a Body Mass Index (BMI) of at least 25 kg/m2 were randomised to receive a hard copy future self-image at recruitment (early image) or after 8 weeks (delayed image). Participants received general healthy lifestyle information at recruitment and were weighed at 4-weekly intervals for 24 weeks. The image was created using an iPad app called 'Future Me'. A second randomisation at 16 weeks allocated either an additional future self-image or no additional image. RESULTS Seventy-four participants were allocated to receive their image at commencement, and 71 to the delayed-image group. Regarding to weight loss, the delayed-image group did consistently better in all analyses. Twenty-four recruits were deemed non-starters, comprising 15 (21%) in the delayed-image group and 9 (12%) in the early-image group (χ2(1) = 2.1, p = 0.15). At 24 weeks there was a significant change in weight overall (p < 0.0001), and a difference in rate of change between groups (delayed-image group: -0.60 kg, early-image group: -0.42 kg, p = 0.01). Men lost weight faster than women. The group into which participants were allocated at week 16 (second image or not) appeared not to influence the outcome (p = 0.31). Analysis of all completers and withdrawals showed a strong trend over time (p < 0.0001), and a difference in rate of change between groups (delayed-image: -0.50 kg, early-image: -0.27 kg, p = 0.0008). CONCLUSION One in five participants in the delayed-image group completing the 24-week intervention achieved a clinically significant weight loss, having received only future self-images and general lifestyle advice. Timing the provision of future self-images appears to be significant, and promising for future research to clarify their efficacy. TRIAL REGISTRATION Australian Clinical Trials Registry, identifier: ACTRN12613000883718 . Registered on 8 August 2013.
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Internet-Delivered Cognitive Behavior Therapy for Adolescents With Irritable Bowel Syndrome: A Randomized Controlled Trial.
Bonnert, M, Olén, O, Lalouni, M, Benninga, MA, Bottai, M, Engelbrektsson, J, Hedman, E, Lenhard, F, Melin, B, Simrén, M, et al
The American journal of gastroenterology. 2017;(1):152-162
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Abstract
OBJECTIVES Few treatments have been able to effectively manage pediatric irritable bowel syndrome (IBS). Internet-delivered cognitive behavior therapy (Internet-CBT) based on exposure for abdominal symptoms is effective for adult IBS. The objective of this study was to evaluate the efficacy of Internet-CBT based on behavioral exposure for adolescents with IBS. METHODS Adolescents with IBS fulfilling the Rome III criteria were randomized to either Internet-CBT or a wait-list control. The Internet-CBT was a 10-week intervention where the main component was exposure to IBS symptoms by reduction of avoidance of abdominal symptoms and instead stepwise provocation of symptoms. The primary outcome was total score on Gastrointestinal Symptoms Rating Scale for IBS (GSRS-IBS). Secondary outcomes included adolescent- and parent-rated quality of life and parent-rated gastrointestinal symptoms. Difference between groups was assessed from pretreatment to posttreatment and the Internet-CBT group was also evaluated at 6 months after treatment completion. RESULTS A total of 101 adolescents with IBS (13-17 years of age) were included in this study. Dropout rates were low (6%) and all randomized patients were included in intent-to-treat analyses based on mixed effects models. Analyses showed a significant larger pretreatment to posttreatment change on the primary outcome GSRS-IBS (B=-6.42, P=0.006, effect size Cohen's d=0.45, 95% confidence interval (0.12, 0.77)) and on almost all secondary outcomes for the Internet-CBT group compared with the control group. After 6 months, the results were stable or significantly improved. CONCLUSIONS Internet-CBT based on exposure exercises for adolescents with IBS can effectively improve gastrointestinal symptoms and quality of life.
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Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial.
Norton, C, Emmanuel, A, Stevens, N, Scott, SM, Grossi, U, Bannister, S, Eldridge, S, Mason, JM, Knowles, CH
Trials. 2017;(1):139
Abstract
BACKGROUND Constipation affects up to 20% of adults. Chronic constipation (CC) affects 1-2% of adults. Patient dissatisfaction is high; nearly 80% feel that laxative therapy is unsatisfactory and symptoms have significant impact on quality of life. There is uncertainty about the value of specialist investigations and whether equipment-intensive therapies using biofeedback confer additional benefit when compared with specialist conservative advice. METHODS/DESIGN A three-arm, parallel-group, multicentre randomised controlled trial. OBJECTIVES to determine whether standardised specialist-led habit training plus pelvic floor retraining using computerised biofeedback is more clinically effective than standardised specialist-led habit training alone; to determine whether outcomes are improved by stratification based on prior investigation of anorectal and colonic pathophysiology. Primary outcome measure is response to treatment, defined as a 0.4-point (10% of scale) or greater reduction in Patient Assessment of Constipation-Quality of Life (PAC-QOL) score 6 months after the end of treatment. Other outcomes up to 12 months include symptoms, quality of life, health economics, psychological health and qualitative experience. HYPOTHESES (1) habit training (HT) with computer-assisted direct visual biofeedback (HTBF) results in an average reduction in PAC-QOL score of 0.4 points at 6 months compared to HT alone in unselected adults with CC, (2) stratification to either HT or HTBF informed by pathophysiological investigation (INVEST) results in an average 0.4-point reduction in PAC-QOL score at 6 months compared with treatment not directed by investigations (No-INVEST). Inclusion: chronic constipation in adults (aged 18-70 years) defined by self-reported symptom duration of more than 6 months; failure of previous laxatives or prokinetics and diet and lifestyle modifications. Consenting participants (n = 394) will be randomised to one of three arms in an allocation ratio of 3:3:2: [1] habit training, [2] habit training and biofeedback or [3] investigation-led allocation to one of these arms. Analysis will be on an intention-to-treat basis. DISCUSSION This trial has the potential to answer some of the major outstanding questions in the management of chronic constipation, including whether costly invasive tests are warranted and whether computer-assisted direct visual biofeedback confers additional benefit to well-managed specialist advice alone. TRIAL REGISTRATION International Standard Randomised Controlled Trial Number: ISRCTN11791740. Registered on 16 July 2015.