1105 A Randomized Controlled Trial of a Psychological Intervention for Decreasing Bedtime Procrastination: The BED-PRO Study

Abstract Introduction Bedtime Procrastination (BP) is defined as the behavior of going to bed later than intended, without having external reasons for doing so. Previous studies have shown that BP has a negative effect on sleep and health, and there is a need to develop interventions to decrease BP. This study (BED-PRO) is an ongoing study evaluating a behavioral intervention to reduce BP. Methods Fifteen participants who scored higher than 33 on the Bedtime Procrastination Scale were randomized to either the treatment (TRT, n=6) or control group (CTRL, n=9). Treatment consisted of four face-to-face individual sessions. All participants completed self-report questionnaires on Bedtime Procrastination Scale (BPS), Epworth Sleepiness Scale (ESS), Positive Affect and Negative Affect Schedule (K-PANAS-R) and completed the 7-day sleep diary. Data was analyzed using two-way mixed Measures Analysis of Variance (ANOVA). Results Mean age of the participants was 21.78 (±1.8) years and 80% (n=12) were females. Group by time interactions from repeated measures analyses revealed significant post intervention improvements in the TRT group compared to the CTRL group on all bedtime procrastination duration and scores, sleep efficiency, refreshment after waking, daytime sleepiness and negative affect of K-PANAS-R. Specifically, bedtime procrastination duration in the TRT group measured by sleep diaries decreased significantly from 75.30 (±58.57) min to 14.83 (±7.83) min, while the CTRL group did not change from 57.60 (±32.01) to 54.36 (±40.82) min (p=0.019). In addition, the TRT group reported significant improvements in bedtime procrastination scores from 36.00 (±4.05) to 22.50 (±6.72). Conclusion Based on results, the behavioral intervention used in this study looks promising in improving bedtime procrastination and sleep. Support This work was supported by the Ministry of Education of the Republic of Korea and the National Research Foundation of Korea(NRF-2018S1A5A8026807)

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A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

10.21203/rs.2.12519/v3 ◽

2020 ◽

Author(s):

Raluca Georgescu ◽

Anca Dobrean ◽

Cristina Alina Silaghi ◽

Horațiu Silaghi

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Repeated Measures ◽

Standard Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Randomized Controlled ◽

Pain Outcomes ◽

Before And After

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as Cognitive Behaviors Therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment.

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A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

10.21203/rs.2.12519/v4 ◽

2021 ◽

Author(s):

Raluca Georgescu ◽

Anca Dobrean ◽

Cristina Alina Silaghi ◽

Horațiu Silaghi

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Repeated Measures ◽

Standard Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Randomized Controlled ◽

Pain Outcomes ◽

Before And After

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0519 Mindfulness Based Therapy for Insomnia Improves Objective Markers of Sleep in the Elderly: Preliminary Data from the Mindfulness Sleep Therapy (MIST) Study

SLEEP ◽

10.1093/sleep/zsaa056.516 ◽

2020 ◽

Vol 43 (Supplement_1) ◽

pp. A198-A199

Author(s):

K F Wong ◽

F Perini ◽

S L Henderson ◽

J Teng ◽

Z Hassirim ◽

...

Keyword(s):

Preliminary Data ◽

Repeated Measures ◽

Mixed Model ◽

Controlled Trial ◽

Sleep Onset ◽

Sleep Diary ◽

Control Group ◽

Poor Sleep ◽

Sleep Onset Latency ◽

Time In Bed

Abstract Introduction Mindfulness-based treatment for insomnia (MBTI) is a viable intervention for improving poor sleep. We report preliminary data from an ongoing pre-registered, randomized controlled trial which investigates the effect of MBTI on elderly adults. Methods Participants above 50 years old with PSQI ≥ 5 were recruited and randomised into either MBTI or an active control group (Sleep hygiene education and exercise program, SHEEP) in sequential cohorts with about 20 participants per cohort (10 per group). Before and after the intervention, 1 night of portable polysomnography (PSG) and 1 week of actigraphy (ACT) and sleep diary (DIARY) data were collected. We report the ACT and DIARY results of the first 3 cohorts (n = 46, male = 23, mean age = 62.3, std = 6.3) and PSG data of the first 2 cohorts (n = 29, male = 12, mean age = 62.5, std = 5.7). Time in bed (TIB), total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency (SE) were analysed with mixed-model repeated-measures ANOVA. Results We observed increases in TIBDIARY (F1,44 = 5.151, p < .05) and SEDIARY (F1,44 = 22.633, p < .0001), and significant reductions in SOLDIARY (F1,44 = 7.031, p < .05) and WASODIARY (F1,39 = 7.411, p < .05). In the actigraphy data, we found a significant interaction in SOLACT (F1,39 = 4.273, p < .05) with an increase in SHEEP SOLACT (t18= 2.36, p < .05). Significant reductions were also observed in WASOACT (F1,44 = 16.459, p < .0001) Finally, we observed a reduction in SOLPSG (F1,26 = 5.037, p <. 05). All other tests were non-significant. Conclusion Preliminary results suggest that both interventions lead to improvements in sleep with more pronounced effects in subjective sleep reports. Objective sleep data suggest that improvements in sleep is a result of improved sleep quality and not simply extending sleep opportunity. These preliminary data shows that MBTI may be a promising intervention for elderly individuals with sleep difficulties. Support This study was supported by an award from the 7th grant call of the Singapore Millennium Foundation Research Grant Programme

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Effect of Individual Psychological Intervention in Chinese Women With Gynecologic Malignancy: A Randomized Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2005.02.069 ◽

2005 ◽

Vol 23 (22) ◽

pp. 4913-4924 ◽

Cited By ~ 21

Author(s):

Y.M. Chan ◽

Peter W.H. Lee ◽

Daniel Y.T. Fong ◽

Amy S.M. Fung ◽

Lina Y.F. Wu ◽

...

Keyword(s):

Quality Of Life ◽

Psychological Intervention ◽

Chinese Women ◽

Controlled Trial ◽

Intervention Group ◽

Self Report ◽

Psychological Status ◽

Control Group ◽

Psychological Therapies

Purpose To evaluate the effectiveness of psychological intervention in the care of cancer patients and to determine whether routine use of individual psychological therapies is indicated. Patients and Methods Patients with newly diagnosed gynecologic malignancies from August 1999 to November 2000 were recruited and randomly assigned to either a control group receiving routine medical care or to an intervention group receiving individual psychotherapy. A set of fixed-choice, self-report questionnaires assessing the patients' psychological status, quality of life, and their perceptions related to the medical consultations was completed at recruitment and then every 3 months for 18 months. Data analysis was performed according to the intention-to-treat principle by fitting the data into a linear mixed-effects model. Multivariable analyses were performed to examine the effects of confounding factors. Results One hundred fifty-five patients participated in the trial. There were no statistically significant differences between the two groups at baseline. There was a trend toward better quality of life and functional status and also improvement of the symptoms over time for both groups. No differences were found between the groups in the scores measured by any of the instruments at baseline and at any time points after the cancer diagnosis. Psychological intervention had no significant effects on the psychosocial parameters. Conclusion Routine use of psychological therapies as given in our format has no significant effect on the patients' quality of life and psychological status.

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A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

10.21203/rs.2.12519/v2 ◽

2020 ◽

Author(s):

Raluca Georgescu ◽

Anca Dobrean ◽

Cristina Alina Silaghi ◽

Horațiu Silaghi

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Repeated Measures ◽

Standard Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Psychological Interventions ◽

Randomized Controlled ◽

Pain Outcomes

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for a proper postoperative care. While several trials have investigated the analgesia analgesic effect of traditional non-pharmacological treatments, such as Cognitive Behaviors Therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adults patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 27 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation on of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment. Keywords: pain; postsurgical pain; virtual reality; psychological interventions; VR-based interventions; Trial registration status: ClinicalTrials, NCT03776344 . Retrospectively registered in December 14, 2018, https://clinicaltrials.gov/ct2/show/NCT03776344 .

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A Virtual Reality based intervention for surgical patients: study protocol of a randomized controlled trial

10.21203/rs.2.12519/v1 ◽

2019 ◽

Author(s):

Raluca Georgescu ◽

Anca Dobrean ◽

Cristina Alina Silaghi ◽

Horațiu Silaghi

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Repeated Measures ◽

Standard Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Successful Implementation ◽

Randomized Controlled ◽

Pain Outcomes

Abstract Background: Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for a proper postoperative care. While several trials have investigated the analgesia effect of traditional non-pharmacological treatments, such Cognitive Behaviors Therapies for pain after surgery, the newer ways of delivering psychological interventions are paucity investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through Virtual Reality (VR) along with the standard pharmacological treatment return better pain outcomes then standard care in adults patients following surgery. Methods: This is a protocol of a parallel RCT conducted in one community hospital. In the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. A minimum of 27 patients is intended to be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing in-depth investigation on the effect of VR environments, the estimates of pain intensity will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment. Discussion: It has already been established that VR can improve the outcomes of pain treatment at burn patients. Successful implementation in post-operative settings has the potential to change the recovery trajectory of individuals with surgical interventions. However, the best mode of implementation in terms of efficacy, acceptability, and side effects is still unclear. The present trial will provide guidance for pain interventions to be implemented on large scale and will provide scientific support in discussing treatment options for individual patients. Trial registration status: ClinicalTrials, NCT03776344. Retrospectively registered in December 14, 2018, https://clinicaltrials.gov/ct2/show/NCT03776344.

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Effects of Open Skill Visuomotor Choice Reaction Time Training on Unanticipated Jump-Landing Stability and Quality: A Randomized Controlled Trial

Frontiers in Human Neuroscience ◽

10.3389/fnhum.2021.683909 ◽

2021 ◽

Vol 15 ◽

Author(s):

David Friebe ◽

Tobias Engeroff ◽

Florian Giesche ◽

Daniel Niederer

Keyword(s):

Reaction Time ◽

Lower Extremity ◽

Interaction Effect ◽

Repeated Measures ◽

Controlled Trial ◽

Reaction Force ◽

Time Factors ◽

Self Report ◽

Control Group ◽

Vertical Ground Reaction Force

Adapting movements rapidly to unanticipated external stimuli is paramount for athletic performance and to prevent injuries. We investigated the effects of a 4-week open-skill choice-reaction training intervention on unanticipated jump-landings. Physically active adults (n = 37; mean age 27, standard deviation 2.7 years, 16 females, 21 males) were randomly allocated to one of two interventions or a control group (CG). Participants in the two intervention groups performed a 4-week visuomotor open skill choice reaction training, one for the upper and one for the lower extremities. Before and after the intervention, two different types of countermovement jumps with landings in split stance position were performed. In the (1) pre-planned condition, we informed the participants regarding the landing position (left or right foot in front position) before the jump. In the (2) unanticipated condition, this information was displayed after take-off (350–600 ms reaction time before landing). Outcomes were landing stability [peak vertical ground reaction force (pGRF) and time to stabilization (TTS)], and landing-related decision-making quality (measured by the number of landing errors). To measure extremity-specific effects, we documented the number of correct hits during the trained drills. A two-factorial (four repeated measures: two conditions, two time factors; three groups) ANCOVA was carried out; conditions = unanticipated versus pre-planned condition, time factors = pre versus post measurement, grouping variable = intervention allocation, co-variates = jumping time and self-report arousal. The training improved performance over the intervention period (upper extremity group: mean of correct choice reaction hits during 5 s drill: +3.0 hits, 95% confidence interval: 2.2–3.9 hits; lower extremity group: +1.6 hits, 0.6–2.6 hits). For pGRF (F = 8.4, p < 0.001) and landing errors (F = 17.1, p < 0.001) repeated measures effect occurred. Significantly more landing errors occurred within the unanticipated condition for all groups and measurement days. The effect in pGRF is mostly impacted by between-condition differences in the CG. No between-group or interaction effect was seen for these outcomes: pGRF (F = 0.4, p = 0.9; F = 2.3, p = 0.1) landing errors (F = 0.5, p = 0.6; F = 2.3, p = 0.1). TTS displayed a repeated measures (F = 4.9, p < 0.001, worse values under the unanticipated condition, improvement over time) and an interaction effect (F = 2.4, p = 0.03). Healthy adults can improve their choice reaction task performance by training. As almost no transfer to unanticipated landing successfulness or movement quality occurred, the effect seems to be task-specific. Lower-extremity reactions to unanticipated stimuli may be improved by more specific training regimens.

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A virtual reality-based intervention for surgical patients: study protocol of a randomized controlled trial

Trials ◽

10.1186/s13063-021-05196-7 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Raluca Diana Georgescu ◽

Anca Dobrean ◽

Cristina Alina Silaghi ◽

Horatiu Silaghi

Keyword(s):

Randomized Controlled Trial ◽

Virtual Reality ◽

Repeated Measures ◽

Standard Treatment ◽

Controlled Trial ◽

Self Report ◽

Control Group ◽

Randomized Controlled ◽

Pain Outcomes ◽

Before And After

Abstract Background Pain after surgery is normal, and treatments, including both pharmacological and psychological components, are fundamental for proper postoperative care. While several trials have investigated the analgesic effect of traditional non-pharmacological treatments, such as cognitive behavior therapies, the newer ways of delivering psychological interventions for pain after surgery are scarcely investigated. The aim of this randomized controlled trial (RCT) is to determine if delivering the psychological content through virtual reality (VR) along with the standard pharmacological treatment return better pain relief outcomes than standard care in adult patients following surgery. Methods This is a protocol of a parallel RCT conducted in one community hospital. In order to test the efficacy of VR environments for reducing pain intensity, in the following day after surgery, adults (18 to 65 years) will be randomly assigned to either (1) standard treatment after surgery (control group) or (2) VR based intervention along with standard treatment. It is intended that a minimum of 30 patients be recruited in each group. For estimating the intensity of pain, both self-report and physiological measures will be used. Repeated measures of pain outcomes will be taken before and after the intervention. Moreover, for allowing an in-depth investigation of the effect of VR environments, the primary outcome will be complemented with measures of the adverse effects, level of immersion, and level of presence in the VR environment.

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Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽

10.1027/0227-5910/a000708 ◽

2020 ◽

pp. 1-7

Author(s):

Karien Hill ◽

Shawn Somerset ◽

Ralf Schwarzer ◽

Carina Chan

Keyword(s):

Suicide Prevention ◽

Suicide Risk ◽

Controlled Trial ◽

Intervention Group ◽

Bystander Intervention ◽

Self Report ◽

Innovative Technology ◽

Control Group ◽

Intervention Model ◽

Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

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Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

Journal of Clinical Oncology ◽

10.1200/jco.2010.30.3909 ◽

2011 ◽

Vol 29 (8) ◽

pp. 1029-1035 ◽

Cited By ~ 204

Author(s):

Donna L. Berry ◽

Brent A. Blumenstein ◽

Barbara Halpenny ◽

Seth Wolpin ◽

Jesse R. Fann ◽

...

Keyword(s):

Controlled Trial ◽

Clinic Visit ◽

Self Report ◽

Comprehensive Cancer Center ◽

Cancer Center ◽

Control Group ◽

Cancer Symptoms ◽

Patient Reported ◽

Life Issues ◽

Clinic Visits

Purpose Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment–Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. Patients and Methods This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. Results The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. Conclusion The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

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