scholarly journals Prehabilitation for Bariatric Surgery: A Randomized, Controlled Trial Protocol and Pilot Study

Nutrients ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2903
Author(s):  
Yaiza García-Delgado ◽  
María José López-Madrazo-Hernández ◽  
Dácil Alvarado-Martel ◽  
Guillermo Miranda-Calderín ◽  
Arantza Ugarte-Lopetegui ◽  
...  

Bariatric surgery is the most efficacious treatment for obesity, though it is not free from complications. Preoperative conditioning has proved beneficial in various clinical contexts, but the evidence is scarce on the role of prehabilitation in bariatric surgery. We describe the protocol and pilot study of a randomized (ratio 1:1), parallel, controlled trial assessing the effect of a physical conditioning and respiratory muscle training programme, added to a standard 8-week group intervention based on therapeutical education and cognitive-behavioural therapy, in patients awaiting bariatric surgery. The primary outcome is preoperative weight-loss. Secondary outcomes include associated comorbidity, eating behaviour, physical activity, quality of life, and short-term postoperative complications. A pilot sample of 15 participants has been randomized to the intervention or control groups and their baseline features and results are described. Only 5 patients completed the group programme and returned for assessment. Measures to improve adherence will be implemented and once the COVID-19 pandemic allows, the clinical trial will start. This is the first randomized, clinical trial assessing the effect of physical and respiratory prehabilitation, added to standard group education and cognitive-behavioural intervention in obese patients on the waiting list for bariatric surgery. Clinical Trial Registration: NCT0404636.

2021 ◽  
pp. 1-11
Author(s):  
Bei Bei ◽  
Donna M. Pinnington ◽  
Nina Quin ◽  
Lin Shen ◽  
Michelle Blumfield ◽  
...  

Abstract Background Sleep disturbance is common in gestational parents during pregnancy and postpartum periods. This study evaluated the feasibility and efficacy of a scalable cognitive behavioural therapy (CBT) sleep intervention tailored for these periods. Methods This is a two-arm, parallel-group, single-blind, superiority randomised controlled trial. Nulliparous females without severe medical/psychiatric conditions were randomised 1:1 to CBT or attention- and time-matched control. All participants received a 1 h telephone session and automated multimedia emails from the third trimester until 6 months postpartum. Outcomes were assessed with validated instruments at gestation weeks 30 (baseline) and 35 (pregnancy endpoint), and postpartum months 1.5, 3, 6 (postpartum endpoint), 12 and 24. Results In total, 163 eligible participants (age M ± s.d. = 33.35 ± 3.42) were randomised. The CBT intervention was well accepted, with no reported adverse effect. Intention-to-treat analyses showed that compared to control, receiving CBT was associated with lower insomnia severity and sleep disturbance (two primary outcomes), and lower sleep-related impairment at the pregnancy endpoint (p values ⩽ 0.001), as well as at 24 months postpartum (p ranges 0.012–0.052). Group differences across the first postpartum year were non-significant. Participants with elevated insomnia symptoms at baseline benefitted substantially more from CBT (v. control), including having significantly lower insomnia symptoms throughout the first postpartum year. Group differences in symptoms of depression or anxiety were non-significant. Conclusions A scalable CBT sleep intervention is efficacious in buffering against sleep disturbance during pregnancy and benefitted sleep at 2-year postpartum, especially for individuals with insomnia symptoms during pregnancy. The intervention holds promise for implementation into routine perinatal care.


2008 ◽  
Vol 193 (6) ◽  
pp. 493-500 ◽  
Author(s):  
U. Schmidt ◽  
M. Andiappan ◽  
M. Grover ◽  
S. Robinson ◽  
S. Perkins ◽  
...  

BackgroundCognitive–behavioural self-care is advocated as a first step in the treatment of bulimia nervosa.AimsTo examine the effectiveness of a CD–ROM-based cognitive–behavioural intervention in bulimia nervosa and eating disorder not otherwise specified (NOS) (bulimic type) in a routine setting.MethodNinety-seven people with bulimia nervosa or eating disorder NOS were randomised to either CD–ROM without support for 3 months followed by a flexible number of therapist sessions or to a 3-month waiting list followed by 15 sessions of therapist cognitive–behavioural therapy (CBT) (ISRCTN51564819). Clinical symptoms were assessed at pre-treatment 3 months and 7 months.ResultsOnly two-thirds of participants started treatment. Although there were significant group × time interactions for bingeing and vomiting, favouring the CD–ROM group at 3 months and the waiting-list group at 7 months, post hoc group comparisons at 3 and 7 months found no significant differences for bingeing or vomiting. CD–ROM-based delivery of this intervention, without support from a clinician, may not be the best way of exploiting its benefits.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Nathalie Claus ◽  
Lisa Marzano ◽  
Johanna Loechner ◽  
Kornelija Starman ◽  
Alessandra Voggt ◽  
...  

Abstract Background Meta-analyses of randomised controlled trials suggest that psychological interventions to reduce children’s risk of depression are effective. Nevertheless, these effects are modest and diminish over time. The Medical Research Council recommends a mixed-methods approach to the evaluation of complex interventions. By gaining a more thorough understanding of participants’ perspectives, qualitative evaluations of preventive interventions could improve their efficacy, longevity and transfer into clinical practice. Methods 18 parents and 22 children who had received a 12-session family- and group-based cognitive-behavioural intervention to prevent youth depression as part of a randomised controlled trial took part in semi-structured interviews or a focus group about aspects which had been perceived as helpful, elements they were still using after the intervention had ended, and suggestions they had for improving the intervention. Results The chance to openly share and discuss their experiences of depression within and between families was considered helpful by both children and parents. Children benefitted the most from learning coping strategies for dealing with stress and many still used them in everyday life. Parents profited mostly from increasing positive family time, but noted that maintaining new routines after the end of the intervention proved difficult. Participants were generally content with the intervention but commented on how tiring and time consuming it was. Conclusions Managing parents’ expectations of family-based interventions in terms of their own mental health needs (versus those of their children) and leaving more room for open discussions may result in interventions which are more appealing to participating families. Increasing intervals between sessions may be one means of improving the longevity of interventions. Trial registration The original RCT this evaluation is a part of was registered under NCT02115880.


2020 ◽  
pp. 1-9
Author(s):  
Tove Wahlund ◽  
David Mataix-Cols ◽  
Klara Olofsdotter Lauri ◽  
Elles de Schipper ◽  
Brjánn Ljótsson ◽  
...  

<b><i>Introduction:</i></b> Worries about the immediate and long-term consequences of the COVID-19 pandemic may for some individuals develop into pervasive worry that is disproportionate in its intensity or duration and significantly interferes with everyday life. <b><i>Objective:</i></b> The aim of this study was to investigate if a brief self-guided, online psychological intervention can reduce the degree of dysfunctional worry related to the COVID-19 pandemic and associated symptoms. <b><i>Methods:</i></b> 670 adults from the Swedish general population reporting daily uncontrollable worry about CO­VID-19 and its possible consequences (e.g., illness, death, the economy, one’s family) were randomised (1:1 ratio) to a 3-week self-guided, online cognitive behavioural intervention targeting dysfunctional COVID-19 worry and associated symptoms, or a waiting list of equal duration. The primary outcome measure was a COVID-19 adapted version of the Generalised Anxiety Disorder 7-item scale administered at baseline and weeks 1–3 (primary endpoint). Follow-up assessments were conducted 1 month after treatment completion. The trial was registered on ClinicalTrials.gov (NCT04341922) before inclusion of the first participant. <b><i>Results:</i></b> The main pre-specified intention-to-treat analysis indicated significant reductions in COVID-19-related worry for the intervention group compared to the waiting list (β = 1.14, <i>Z</i> = 9.27, <i>p</i> &#x3c; 0.001), corresponding to a medium effect size (bootstrapped <i>d</i> = 0.74 [95% CI: 0.58–0.90]). Improvements were also seen on all secondary measures, including mood, daily functioning, insomnia, and intolerance of uncertainty. Participant satisfaction was high. No serious adverse events were recorded. <b><i>Conclusions:</i></b> A brief digital and easily scalable self-guided psychological intervention can significantly reduce dysfunctional worry and associated behavioural symptoms related to the COVID-19 pandemic.


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