scholarly journals Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomized controlled trial.

2019 ◽  
Author(s):  
Niccolò Butti ◽  
Emilia Biffi ◽  
Chiara Genova ◽  
Romina Romaniello ◽  
Davide Felice Redaelli ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Cognition ◽  
Active Control ◽  
Controlled Trial ◽  
Control Group ◽  
Active Control Group ◽  
Intensive Training ◽  
Randomized Controlled ◽  
Cerebellar Malformations ◽  
Social Prediction

Abstract Background: Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities, such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit). Methods: The study is an interventional randomized controlled trial that aims to recruit 42 children, adolescents and young adults with congenital cerebellar malformations, randomly allocated to the experimental or active control group. The experimental group is administered the VR-Spirit, requiring the participants to compete with different avatars in the reaching of recreational equipment and implicitly prompting them to form expectations about their playing preference. The active control group participates to a VR-training with standard games currently adopted for motor rehabilitation. Both trainings are composed by 8 45-minute sessions and are administered in the GRAIL VR-Lab (Motekforce Link, NL), an integrated platform that allows patients to move in natural and attractive VR environments. An evaluation session in VR with the same paradigm used in the VR-Spirit but implemented in a different scenario is administered at the beginning (T0) and at the end (T1) of the two trainings. Moreover, a battery of neurocognitive tests spanning different domains are administered to all participants at T0, T1 and in a follow-up session after two months from the end of the two trainings (T2). Discussion: This study offers a novel approach for rehabilitation based on specific neural mechanisms of the cerebellum. We aim to investigate the feasibility and efficacy of a new intensive social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations. We expect that VR-Spirit could enhance social prediction ability and indirectly improve cognitive performance in diverse domains. Moreover, through the comparison with a VR-active control training we aim to verify the specificity of VR-Spirit in improving social perception skills.

scholarly journals Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomized controlled trial.

2019 ◽  
Author(s):  
Niccolò Butti ◽  
Emilia Biffi ◽  
Chiara Genova ◽  
Romina Romaniello ◽  
Davide Felice Redaelli ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Social Cognition ◽  
Active Control ◽  
Controlled Trial ◽  
Control Group ◽  
Active Control Group ◽  
Intensive Training ◽  
Randomized Controlled ◽  
Cerebellar Malformations ◽  
Social Prediction

Abstract Background: Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities, such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit). Methods: The study is an interventional randomized controlled trial that aims to recruit 42 children, adolescents and young adults with congenital cerebellar malformations, randomly allocated to the experimental or active control group. The experimental group is administered the VR-Spirit, requiring the participants to compete with different avatars in the reaching of recreational equipment and implicitly prompting them to form expectations about their playing preference. The active control group participates to a VR-training with standard games currently adopted for motor rehabilitation. Both trainings are composed by 8 45-minute sessions and are administered in the GRAIL VR-Lab (Motekforce Link, NL), an integrated platform that allows patients to move in natural and attractive VR environments. An evaluation session in VR with the same paradigm used in the VR-Spirit but implemented in a different scenario is administered at the beginning (T0) and at the end (T1) of the two trainings. Moreover, a battery of neurocognitive tests spanning different domains are administered to all participants at T0, T1 and in a follow-up session after two months from the end of the two trainings (T2). Discussion: This study offers a novel approach for rehabilitation based on specific neural mechanisms of the cerebellum. We aim to investigate the feasibility and efficacy of a new intensive social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations. We expect that VR-Spirit could enhance social prediction ability and indirectly improve cognitive performance in diverse domains. Moreover, through the comparison with a VR-active control training we aim to verify the specificity of VR-Spirit in improving social perception skills.

scholarly journals Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomized controlled trial.

2019 ◽  
Author(s):  
Niccolò Butti ◽  
Emilia Biffi ◽  
Chiara Genova ◽  
Romina Romaniello ◽  
Davide Felice Redaelli ◽  
...  
Keyword(s):  
Social Cognition ◽  
Active Control ◽  
Controlled Trial ◽  
Control Group ◽  
Active Control Group ◽  
Intensive Training ◽  
Randomized Controlled ◽  
Cerebellar Malformations ◽  
Social Prediction ◽  
Social Cognition Training

Abstract Background: Patients with cerebellar malformations exhibit not only movement problems, but also important deficits in social cognition. Thus, rehabilitation approaches should not only involve the recovery of motor function but also of higher-order abilities, such as processing of social stimuli. In keeping with the general role of the cerebellum in anticipating and predicting events, we used a VR-based rehabilitation system to implement a social cognition intensive training specifically tailored to improve predictive abilities in social scenarios (VR-Spirit).Methods: The study is an interventional randomized controlled trial that aims to recruit 42 children, adolescents and young adults with congenital cerebellar malformations, randomly allocated to the experimental or active control group. The experimental group is administered the VR-Spirit, requiring the participants to compete with different avatars in the reaching of recreational equipment and implicitly prompting them to form expectations about their playing preference. The active control group participates to a VR-training with standard games currently adopted for motor rehabilitation. Both trainings are composed by 8 45-minute sessions and are administered in the GRAIL VR-Lab (Motekforce Link, NL), an integrated platform that allows patients to move in natural and attractive VR environments. An evaluation session in VR with the same paradigm used in the VR-Spirit but implemented in a different scenario is administered at the beginning (T0) of the two trainings (T1) and at the end (T2). Moreover, a battery of neurocognitive tests spanning different domains are administered to all participants at T0, T2 and in a follow-up session after two months from the end of the two trainings (T3).Discussion: This study offers a novel approach for rehabilitation based on specific neural mechanisms of the cerebellum. We aim to investigate the feasibility and efficacy of a new intensive social cognition training in a sample of Italian patients aged 7-25 years with congenital cerebellar malformations. We expect that VR-Spirit could enhance social prediction ability and indirectly improve cognitive performance in diverse domains. Moreover, through the comparison with a VR-active control training we aim to verify the specificity of VR-Spirit in improving social perception skills.Trial registration: ISRCTN, ISRCTN 22332873. Retrospectively registered on 12 March 2018. http://www.isrctn.com/ISRCTN22332873Keywords: Virtual reality; Social cognition training; Cerebellum; Paediatric patients; Rehabilitation; Grail.

Promoting Volunteering Among Older Adults in Hong Kong: A Randomized Controlled Trial

2019 ◽  
Vol 60 (5) ◽  
pp. 968-977 ◽  
Author(s):  
Da Jiang ◽  
Lisa M Warner ◽  
Alice Ming-Lin Chong ◽  
Tianyuan Li ◽  
Julia K Wolff ◽  
...  
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Hong Kong ◽  
Active Control ◽  
Controlled Trial ◽  
Action Planning ◽  
Control Group ◽  
Active Control Group ◽  
Randomized Controlled ◽  
Experimental Group

Abstract Background and Objectives Volunteering has consistently been associated with better mental, physical, and cognitive health in older adulthood. However, the volunteering rate of older adults in Hong Kong is much lower than in Western countries. Few studies have examined whether interventions can be effective in motivating older adults to volunteer in Hong Kong. To fill this gap, we conducted a randomized controlled trial to examine the impact of a theory-based social-cognitive intervention on volunteering. Research Design and Methods A total of 264 community-dwelling older adults in Hong Kong (Mage = 69.95 years, SDage = 6.90 years, 81.06% female) were randomly assigned to either an experimental group or an active control group. Participants in the experimental group received 4 weekly 1-hr face-to-face volunteering intervention sessions. Those in the active control group received parallel sessions targeting physical activity instead of volunteering. The time spent on volunteering per month was self-reported and measured at baseline, 6 weeks, 3 months, and 6 months after the intervention. Self-efficacy, intention, action planning, and self-monitoring of volunteering were measured as mediators. Results Monthly volunteering minutes increased among participants in the experimental group when compared with the active control group at 6-week, 3-month, and 6-month follow-ups. Self-efficacy, intention, and action planning consistently mediated the effect of the intervention on volunteering minutes. Discussion and Implications The findings demonstrate the effectiveness of the intervention on volunteering behavior in older adults in Hong Kong through well-established behavior change techniques.

Mindfulness Training and Attentional Control in Older Adults: A Randomized Controlled Trial

2018 ◽  
Author(s):  
Patrick Whitmoyer ◽  
Stephanie Fountain-Zargoza ◽  
Rebecca Andridge ◽  
Keith Bredemeier ◽  
Allison Londerée ◽  
...  
Keyword(s):  
Older Adults ◽  
Working Memory ◽  
Randomized Controlled Trial ◽  
Active Control ◽  
Attentional Control ◽  
Controlled Trial ◽  
Mindfulness Training ◽  
Control Group ◽  
Active Control Group ◽  
Randomized Controlled

Mindfulness-based interventions have been found to improve facets of attentional control. However, comparison with active control groups has been scarce, and few studies have examined mindfulness as a means to ameliorate age-related cognitive deficits. This rigorously-designed, placebo-controlled randomized controlled trial, investigated the effects of mindfulness-based attention training (MBAT) on attentional control in older adults relative to an active control group. Seventy-four community-dwelling older adults were randomized to four weeks of MBAT or an active lifestyle eduction control group. Pre- and post-intervention, participants completed two computerized measures of attentional control with intermittent assessments of self-reported mind-wandering. Although we found some evidence for greater reductions in mind-wandering in the MBAT than the active control group, the MBAT group did not exhibit greater improvements in attentional performance. Exploratory analyses revealed working memory as a significant moderator of the observed effects, such that those in the MBAT group with higher working memory showed greater improvement in attentional control. Thus, we found preliminary evidence for attentional benefits following mindfulness training only in individuals with high working memory. Our results call for more rigorous implementation of RCT methodology in future investigations of mindfulness training’s benefits for cognitive functioning in older adults.

scholarly journals A Randomized Controlled Trial of Illness Management and Recovery With an Active Control Group

2014 ◽  
Vol 65 (8) ◽  
pp. 1005-1011 ◽  
Author(s):  
Michelle P. Salyers ◽  
Alan B. McGuire ◽  
Marina Kukla ◽  
Sadaaki Fukui ◽  
Paul H. Lysaker ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Active Control ◽  
Controlled Trial ◽  
Control Group ◽  
Illness Management ◽  
Active Control Group ◽  
Illness Management And Recovery ◽  
Randomized Controlled

scholarly journals Mindfulness-Based Program Plus Amygdala and Insula Retraining (MAIR) for the Treatment of Women with Fibromyalgia: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 9 (10) ◽  
pp. 3246
Author(s):  
Juan P. Sanabria-Mazo ◽  
Jesus Montero-Marin ◽  
Albert Feliu-Soler ◽  
Virginia Gasión ◽  
Mayte Navarro-Gil ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Treatment ◽  
Effect Sizes ◽  
Control Group ◽  
Active Control Group ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ≥50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-α, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.

scholarly journals Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews (Preprint)

2020 ◽  
Author(s):  
Cyd Eaton ◽  
Margaret Comer ◽  
Cozumel Pruette ◽  
Kevin Psoter ◽  
Kristin Riekert
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Medication Adherence ◽  
Active Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Significant Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. OBJECTIVE In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants’ antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. METHODS In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. RESULTS Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, <i>P</i>=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants’ perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). CONCLUSIONS The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants’ daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention’s mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. CLINICALTRIAL ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596

scholarly journals Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews

10.2196/19861 ◽  
2020 ◽  
Vol 22 (8) ◽  
pp. e19861
Author(s):  
Cyd Eaton ◽  
Margaret Comer ◽  
Cozumel Pruette ◽  
Kevin Psoter ◽  
Kristin Riekert
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Medication Adherence ◽  
Active Control ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Significant Group ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities. Objective In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants’ antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained. Methods In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group. Results Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants’ perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken). Conclusions The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants’ daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention’s mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability. Trial Registration ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596

scholarly journals Evaluation of a Novel Psychological Intervention Tailored for Patients With Early Cognitive Impairment (PIPCI): Study Protocol of a Randomized Controlled Trial

2020 ◽  
Vol 11 ◽  
Author(s):  
Urban Ekman ◽  
Mike K. Kemani ◽  
John Wallert ◽  
Rikard K. Wicksell ◽  
Linda Holmström ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Active Control ◽  
Psychological Health ◽  
Early Phase ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
Waiting List ◽  
Control Group ◽  
Active Control Group ◽  
Randomized Controlled

BackgroundIndividuals with early phase cognitive impairment are frequently affected by existential distress, social avoidance and associated health issues (including symptoms of stress, anxiety, and depression). The demand for efficient psychological support is crucial from both an individual and a societal perspective. We have developed a novel psychological intervention (Psychological Intervention tailored for Patients with Cognitive Impairment, PIPCI) manual for providing a non-medical path to enhanced psychological health in the cognitively impaired population. The current article provides specific information on the randomized controlled trial (RCT)-design and methods. The main hypothesis is that participants receiving PIPCI will increase their psychological flexibility (the ability to notice and accept interfering thoughts, emotions, and bodily sensations without acting on them, when this serves action in line with personal values) compared to participants in the active control (cognitive training) group and the waiting list control group. The secondary hypotheses are that participants receiving PIPCI will improve psychological health (stress measures, quality of life, depression, and general health) compared to participants in the active control group and the waiting list control group.Materials and MethodsThis three-arm RCT will recruit participants from the cognitive centers at Karolinska University Hospital in Stockholm and randomize approximately 120 individuals in the early phase of cognitive impairment to either an experimental group (psychological intervention once a week for 10 weeks), an active control group (cognitive training once a week for 10 weeks) or a waiting list control group. Intervention outcome will be evaluated with self-report questionnaires on physical and psychological aspects of health, cognitive assessment, biological markers (obtained from blood and saliva) and health care costs. Assessments will be performed at pre- (1 week before the interventions) and post-intervention (1 week after the interventions), as well as at a 6-month follow-up.DiscussionThe development of a potentially feasible and effective psychological intervention tailored for early phase cognitive impairment (PIPCI) has the potential to advance the non-pharmacological intervention field. This is especially important given the extensive burden for many affected individuals and their families and the current lack of effective treatments. If the psychological intervention discussed here shows feasibility and efficacy, there is potential for far-reaching healthcare implications for patients with early cognitive impairment at risk of developing dementia.Clinical Trial RegistrationClinicalTrials.gov: NCT04356924. Date of registration: April 22, 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04356924.

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