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APOLO-Teens, a web-based intervention for treatment-seeking adolescents with overweight or obesity: study protocol and baseline characterization of a Portuguese sample.
Ramalho, S, Saint-Maurice, PF, Silva, D, Mansilha, HF, Silva, C, Gonçalves, S, Machado, P, Conceição, E
Eating and weight disorders : EWD. 2020;(2):453-463
Abstract
PURPOSE APOLO-Teens is an ongoing web-based program combining a manualized intervention delivered by Facebook®, a self-monitoring web application and monthly chat sessions to optimize treatment as usual for adolescents with overweight and obesity. The aims of this paper are twofold: (1) to describe the study protocol of the APOLO-Teens randomized controlled effectiveness trial and (2) to present baseline descriptive information of the Portuguese sample. METHODS APOLO-Teens includes adolescents aged between 13 and 18 years with BMI percentile ≥ 85 (N = 210; 60.00% girls, BMI z-score 2.40 ± 0.75) undergoing hospital ambulatory treatment for overweight/obesity. Participants completed a set of self-report measures regarding eating behaviors and habits, psychological functioning (depression, anxiety, stress, and impulsivity), physical activity, and quality of life. RESULTS Depression, anxiety, stress, impulsivity, and percentage body fat were inversely associated with health-related quality of life (rs = - 0.39 to - 0.62), while physical activity out-of-school was positively correlated with health-related quality of life (rs = 0.22). When compared to boys, girls demonstrated statistically significant higher scores on psychological distress, disturbed eating behaviors, impulsivity, were less active at school and had lower scores on the health-related quality of life (p < 0.05). CONCLUSION The results showed that there were gender differences in key psychological constructs that are likely to determine success with the treatment and that, therefore, need to be considered in future interventions. The results of APOLO-Teens randomized controlled trial will determine the impact of these constructs on the efficacy and adherence to a web-based intervention for weight loss in the Portuguese population. LEVEL OF EVIDENCE Level V, cross-sectional descriptive study.
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Tailoring Cognitive Behavioral Therapy for Depression and Anxiety Symptoms in Mexican Terminal Cancer Patients: A Multiple Baseline Study.
Landa-Ramírez, E, Greer, JA, Sánchez-Román, S, Manolov, R, Salado-Avila, MM, Templos-Esteban, LA, Riveros-Rosas, A
Journal of clinical psychology in medical settings. 2020;(1):54-67
Abstract
The purpose of this study was to assess the effect of tailored cognitive behavioral therapy (CBT) on depression and anxiety symptoms present in Mexican terminal cancer patients. A non-concurrent multiple baseline design was used across individuals. Nine patients participated in the study, each receiving four to six therapy sessions. The effect size of the intervention range (NAP and Tau indexes) in the nine patients indicates that CBT intervention resulted in weak to moderate impact for anxiety and depression symptoms in this population. The overall standardized mean difference is also moderate, with a reduction of 0.54 and 0.76 standard deviations in depression and anxiety symptoms, respectively. This study provides initial evidence to support a positive effect from CBT on patients with terminal cancer and with mood disorders when facing their impending death.
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Is physical exercise and dietary therapy a feasible alternative to cognitive behavior therapy in treatment of eating disorders? A randomized controlled trial of two group therapies.
Mathisen, TF, Rosenvinge, JH, Friborg, O, Vrabel, K, Bratland-Sanda, S, Pettersen, G, Sundgot-Borgen, J
The International journal of eating disorders. 2020;(4):574-585
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OBJECTIVE To compare effects of physical exercise and dietary therapy (PED-t) to cognitive behavioral therapy (CBT) in treatment of bulimia nervosa (BN) and binge-eating disorder (BED). METHOD The active sample (18-40 years of age) consisted of 76 women in the PED-t condition and 73 in the CBT condition. Participants who chose not to initiate treatment immediately (n = 23) were put on a waiting list. Outcome measures were the eating disorder examination questionnaire (EDE-Q), Clinical Impairment Assessment (CIA), Satisfaction with Life Scale (SWLS), Beck Depression Inventory (BDI), and numbers in remission at posttreatment, and at 6-, 12-, and 24-months follow-up. RESULTS Both treatment conditions produced medium to strong significant improvements on all outcomes with long-term effect. The PED-t produced a faster improvement in EDE-Q and CIA, but these differences vanished at follow-ups. Only PED-t provided improvements in BDI, still with no between-group difference. Totally, 30-50% of participants responded favorable to treatments, with no statistical between-group difference. DISCUSSION Both treatments shared a focus on normalizing eating patterns, correcting basic self-regulatory processes and reducing idealized aesthetic evaluations of self-worth. The results point to the PED-t as an alternative to CBT for BN and BED, although results are limited due to compliance and dropout rates. Replications are needed by independent research groups as well as in more clinical settings.
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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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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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Weight Reduction Through a Cognitive Behavioral Therapy Lifestyle Intervention in PCOS: The Primary Outcome of a Randomized Controlled Trial.
Jiskoot, G, Timman, R, Beerthuizen, A, Dietz de Loos, A, Busschbach, J, Laven, J
Obesity (Silver Spring, Md.). 2020;(11):2134-2141
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OBJECTIVE Long-term weight loss is important and difficult to achieve for many women with polycystic ovary syndrome (PCOS). Lifestyle interventions (LS) in PCOS have shown moderate short-term effects. Three-component LS that combine nutrition advice, exercise, and cognitive behavioral therapy have not been tested in long-term interventions. METHODS Women (N = 183) with PCOS who were trying to conceive and had BMI > 25 kg/m2 were assigned to 20 group sessions of cognitive behavioral therapy combined with nutrition advice and exercise (LS with or without Short Message Service [SMS] via mobile phone) or care as usual (CAU). RESULTS More weight loss was observed in LS than in CAU (P < 0.001). Adding SMS was even more effective (P = 0.017). In CAU, 13 of 60 (21.8%) succeeded in achieving a 5% weight loss, as did 32 of 60 (52.8%) in LS without SMS and 54 of 63 (85.7%) in LS with SMS. The odds of achieving a 5% weight loss were 7.0 (P < 0.001) in LS compared with CAU. More than 18 of 60 (29.0%) of the women in CAU gained weight versus 5 of 60 (8.5%) and 2 of 63 (3.1%) in LS without or with SMS, respectively. The overall dropout rate was 116 of 183 (63.4%). CONCLUSIONS A three-component LS program resulted in reasonable weight loss in women with PCOS. Adding SMS resulted in more weight loss.
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Feasibility and Acceptability of a Remotely Delivered, Web-Based Behavioral Intervention for Men With Prostate Cancer: Four-Arm Randomized Controlled Pilot Trial.
Chan, JM, Van Blarigan, EL, Langlais, CS, Zhao, S, Ramsdill, JW, Daniel, K, Macaire, G, Wang, E, Paich, K, Kessler, ER, et al
Journal of medical Internet research. 2020;(12):e19238
Abstract
BACKGROUND Diet and exercise may be associated with quality of life and survival in men with prostate cancer. OBJECTIVE This study aimed to determine the feasibility and acceptability of a remotely delivered web-based behavioral intervention among men with prostate cancer. METHODS We conducted a multi-site 4-arm pilot randomized controlled trial of a 3-month intervention (TrueNTH Community of Wellness). Eligibility included self-reported prostate cancer diagnosis, having a personal device that connected to the internet, age ≥18 years, and ability to read English and receive text messages and emails. Men receiving chemotherapy or radiation, or those who reported contraindications to exercise, could participate with physician clearance. Participants were randomized (1:1:1:1) to additive intervention levels: website; website and personalized diet and exercise prescription; website, personalized prescription, Fitbit, and text messages; and website, personalized prescription, Fitbit, text messages, and 2 30-minute phone calls-one with an exercise trainer and one with a registered dietician. Primary outcomes were feasibility (accrual and attrition) and acceptability (survey data and website use). We described self-reported diet and exercise behavior at the time of enrollment, 3 months, and 6 months as secondary outcomes. RESULTS In total, 202 men consented and were randomized between August 2017 and September 2018 (level 1: 49, level 2: 51, level 3: 50, level 4: 52). A total of 160 men completed the onboarding process and were exposed to their randomly assigned intervention (38, 38, 42, and 42 in levels 1, 2, 3, and 4, respectively). The follow-up rate was 82.7% (167/202) at 3 months and 77.2% (156/202) at 6 months. Participants had a median age of 70 years and were primarily White and college educated. Website visit frequency over the 3-month intervention period increased across levels (median: 2, 9, 11, and 16 visits for levels 1, 2, 3, and 4, respectively). Most were satisfied or very satisfied with the intervention (20/39, 51%; 27/42, 64%; 23/44, 52%; and 27/42, 64% for levels 1, 2, 3, and 4, respectively). The percentage of men who reported being very satisfied was highest among level 4 participants (10/42, 24% vs 4/39, 10%; 5/42, 12%; and 5/44, 11% for levels 1, 2, and 3, respectively). Dissatisfaction was highest in level 1 (5/39, 13% vs 1/42, 2%; 3/44, 7%; and 2/42, 5% for levels 2, 3, and 4, respectively). We observed small improvements in diet and physical activity at 3 months among men in level 4 versus those in level 1. CONCLUSIONS A web-based, remotely delivered, tailored behavioral intervention for men with prostate cancer is feasible. Future studies are warranted to increase the effect of the intervention on patient behavior while maintaining sustainability and scalability as well as to design and implement interventions for more diverse populations. TRIAL REGISTRATION ClinicalTrials.gov NCT03406013; http://clinicaltrials.gov/ct2/show/NCT03406013.
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The effects of Pythagorean Self-Awareness Intervention on breast cancer patients undergoing adjuvant therapy: A pilot randomized controlled trial.
Charalampopoulou, M, Bacopoulou, F, Syrigos, KN, Filopoulos, E, Chrousos, GP, Darviri, C
Breast (Edinburgh, Scotland). 2020;:210-218
Abstract
INTRODUCTION Breast cancer patients undergo extended treatments that affect their psychological state and quality of life. There is a lack of studies examining the effects of holistic stress management interventions (that combine stress perception, cognitive and lifestyle interventions) on mental health and biological indices (e.g. cortisol concentrations) of breast cancer patients. MATERIALS AND METHODS This pilot randomized controlled trial provided the first assessment of the effects of a novel, cognitive-based intervention, the Pythagorean Self-Awareness Intervention (PSAI), on psychological symptoms, quality of life, sleep quality and lifestyle as well as on stress-related biological measures of breast cancer patients undergoing adjuvant therapy. Standardized questionnaires were administered at baseline and 8-weeksafter the intervention to evaluate quality of life, stress, depression, and anxiety (primary outcomes). Sleep quality, lifestyle and hair cortisol concentrations were also assessed (secondary outcomes). RESULTS Forty-five breast cancer patients undergoing adjuvant therapy were randomly assigned to the PSAI group (n = 25) or the control group (n = 20).Women in the PSAI group reported significant improvements post-intervention in total Quality of Life, specific aspects of Quality of Life [Physical well-being, Social well-being, Emotional well-being, Functional well-being, Breast cancer concerns] as well as Perceived stress, depression, anxiety and stress. Improvements in secondary outcomes included increase in sleep quality, empowerment for healthy lifestyle and reduction of hair cortisol concentrations. CONCLUSIONS The PSAI was beneficial as complementary therapy in the women studied. Larger randomized controlled trials with longer follow-up are needed to ascertain these findings.
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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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Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors.
Holtdirk, F, Mehnert, A, Weiss, M, Meyer, B, Watzl, C
Trials. 2020;(1):117
Abstract
INTRODUCTION Depression and fatigue are common in breast cancer survivors, and their presence is associated with personal suffering and worse prognosis. While many women receive short-term psychological support in the acute treatment phase, this is rarely available in subsequent phases. Internet interventions for breast cancer survivors could provide additional psychological support, as they are easily accessible and may be effective. However, no trial has yet examined the effectiveness of an Internet intervention that provides cognitive behavioural therapy techniques plus lifestyle advice for this population. This trial aims to test whether Optimune, a novel Internet intervention we developed for that purpose, leads to improvements in quality of life and relevant lifestyle habits over the course of 3 to 6 months. METHODS This randomized controlled trial (RCT) will include 360 female breast cancer survivors who have completed the active tumour eradication phase. Participants will be recruited from various settings, including web-based advertisements and Internet forums in German-speaking countries. The main inclusion criteria are a breast cancer diagnosis less than 5 years ago and completion of acute treatment at least 1 month ago, as verified by discharge letter from an oncology treatment centre. Participants will be randomly assigned to either (1) a control group, in which they receive care as usual (CAU) and are given access to Optimune after a delay of 3 months (CAU/wait list control), or (2) a treatment group that may also use CAU and will receive 12-month access to Optimune immediately after randomization. The three primary endpoints are quality of life, physical activity and diet quality, assessed with the World Health Organization Quality of Life Questionnaire, the International Physical Activity Questionnaire and the Food Quality Questionnaire, at 3 months post-baseline; secondary outcomes include cancer-related fatigue, emotional stress, depression, anxiety, fear of progression, insomnia, usefulness of the programme and negative treatment effects. Online assessments are conducted at baseline (T0), 3 months (T1) and 6 months (T2). DISCUSSION Results of this RCT are expected to extend the body of knowledge with regard to the effectiveness of CBT-based Internet interventions for female breast cancer survivors. TRIAL REGISTRATION ClinicalTrials.gov, NCT03643640. Registered on 23 August 2018.