scholarly journals A randomized controlled trial of an Internet-based emotion regulation intervention for sexual health: study protocol

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Vinicius Jobim Fischer ◽  
Gerhard Andersson ◽  
Joël Billieux ◽  
Claus Vögele
Keyword(s):  
Randomized Controlled Trial ◽  
Emotion Regulation ◽  
Sexual Health ◽  
Controlled Trial ◽  
Self Report ◽  
Health Study ◽  
Self Perception ◽  
Waitlist Control ◽  
Face To Face ◽  
Randomized Controlled

Abstract Introduction Emotion regulation difficulties have been associated with mental disorders and sexual dysfunctions. Traditional face-to-face transdiagnostic emotion regulation interventions have shown positive results for emotional and personality disorders. Only recently have the effects of these interventions on sexual health started to be investigated. Internet-delivered psychological interventions have several advantages over face-to-face interventions, such as cost-effectiveness, accessibility, and suitability for people who experience shame because of their stigmatized problematic behaviors and those who avoid seeking help. The aims of the SHER 2—TREpS (Portuguese acronym for Emotion Regulation training for sexual health) project are as follows: (a) determine the efficacy of an Internet-based emotion regulation intervention for sexual health and sexual satisfaction and (b) explore the effects of the intervention on (1) emotion regulation skills, (2) mental health, and (3) sexual self-perception. Methods and analysis The study will use a randomized controlled trial design. Eligible participants will be randomly allocated to one of two groups: intervention (Internet-based emotion regulation training) or waitlist control. Assessments will take place before the start of the trial, at the end of the trial, and at 6-month follow up, after which participants assigned to the waitlist control condition will receive the same intervention. Primary outcomes include sexual function and satisfaction and secondary outcomes self-report measures of depression, anxiety, difficulties in emotion regulation, and sexual self-perception. This intervention study is financed by the Luxembourg National Research Fund (FNS). Ethics and dissemination Ethics approval was obtained from the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.

scholarly journals A randomized controlled trial of an Internet-based emotion regulation intervention for sexual health: study protocol

2021 ◽  
Author(s):  
Vinicius Jobim Fischer ◽  
Gerhard Andersson ◽  
Joël Billieux ◽  
Claus Vögele
Keyword(s):  
Randomized Controlled Trial ◽  
Emotion Regulation ◽  
Sexual Health ◽  
Controlled Trial ◽  
Self Report ◽  
Health Study ◽  
Self Perception ◽  
Waitlist Control ◽  
Face To Face ◽  
Randomized Controlled

Abstract Introduction: Emotion regulation difficulties have been associated with mental disorders and sexual dysfunctions. Traditional face-to-face transdiagnostic emotion regulation interventions have shown positive results for emotional and personality disorders. Only recently have the effects of these interventions on sexual health started to be investigated. Internet-delivered psychological interventions have several advantages over face-to-face interventions, such as cost-effectiveness, accessibility and suitability for people who experience shame because of their stigmatized problematic behaviors and those who avoid seeking help. The aims of the SHER 2 - TREpS (Portuguese acronym for Emotion Regulation training for sexual health) project are: a) determine the efficacy of an Internet-based emotion regulation intervention for sexual health and sexual satisfaction, and; b) explore the effects of the intervention on (1) emotion regulation skills; (2) mental health; (3) sexual self-perception. Methods and AnalysisThe study will use a randomized controlled trial design. Eligible participants will be randomly allocated to one of two groups: intervention (Internet-based emotion regulation training) or waitlist control. Assessments will take place before the start of the trial, at the end of the trial and at 6-month follow up, after which participants assigned to the waitlist control condition will receive the same intervention. Primary outcomes include sexual function and satisfaction, and secondary outcomes self-report measures of depression, anxiety, difficulties in emotion regulation, and sexual self-perception. This intervention study is financed by the Luxembourg National Research Fund (FNS). Ethics and dissemination: Ethics approval was obtained from the Ethics Review Panel of the University of Luxembourg. Findings will be disseminated via peer-reviewed publications and conference presentations.

Conducting Clinical Research Remotely for Individuals with Traumatic Brain Injury (TBI) and Depression during the COVID-19 Pandemic: Transitioning from In-Person to Remote Implementation (Preprint)

2021 ◽  
Author(s):  
Lauren B Fisher ◽  
Sylvie Tuchman ◽  
Andrew Curreri ◽  
Maggie Markgraf ◽  
Maren B Nyer ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Brain Injury ◽  
Controlled Trial ◽  
Self Report ◽  
Health Study ◽  
Telemental Health ◽  
Medical Diagnoses ◽  
Randomized Controlled

BACKGROUND Telehealth provided many researchers, especially those conducting psychosocial research, with the tools necessary to transition in-person clinical trials to remote implementation during the COVID-19 pandemic. A growing body of research supports the effectiveness of telemental health for a variety of psychiatric conditions, but few studies have examined telemental health for individuals with comorbid medical diagnoses. Furthermore, little is known about the remote implementation of clinical trials examining telemental health interventions. OBJECTIVE This paper outlines the procedural modifications used to facilitate conversion of an in-person randomized controlled trial of cognitive behavioral therapy (CBT) for individuals with depression and traumatic brain injury (TBI), CBT-TBI, to a telemental health study that is administered remotely. METHODS Given the nature of remote implementation and specific challenges experienced by individuals with TBI, considerations related to treatment delivery, remote consent, data management, neuropsychological assessment, safety monitoring, and delivery of supportive material are discussed. Feasibility, acceptability, and safety are evaluated by examining attendance and participant responses on self-report measures of treatment satisfaction and suicidal behavior. RESULTS High rates of treatment attendance, assessment completion, study retention, and satisfaction with the intervention and modality are reported by participants who completed at least one telemental health CBT-TBI session. CONCLUSIONS Study modifications are necessary when conducting a study remotely, and special attention should be paid to comorbidities and population-specific challenges (e.g., cognitive impairment). Preliminary data supports the feasibility, acceptability, and safety of remotely conducting a randomized controlled trial of CBT for depression after TBI. CLINICALTRIAL NCT03307070 https://clinicaltrials.gov/ct2/show/NCT03307070?cond=Traumatic+Brain+Injury&locn=boston&age=1&draw=3&rank=11

Telemedicine for New Neurological Outpatients: Putting a Randomized Controlled Trial in the Context of Everyday Practice

2002 ◽  
Vol 8 (5) ◽  
pp. 270-273 ◽  
Author(s):  
Richard Chua ◽  
John Craig ◽  
Thomas Esmonde ◽  
Richard Wootton ◽  
Victor Patterson
Keyword(s):  
Randomized Controlled Trial ◽  
Outcome Measures ◽  
Retrospective Review ◽  
Controlled Trial ◽  
The Other ◽  
Everyday Practice ◽  
General Hospitals ◽  
Face To Face ◽  
Randomized Controlled ◽  
General Physicians

In a retrospective review, the telemedical management of 65 outpatients from a randomized controlled trial (RCT) of telemedicine for non-urgent referrals to a consultant neurologist was compared with the management of 76 patients seen face to face in the same trial, with that of 150 outpatients seen in the neurology clinics of district general hospitals and with that of 102 neurological outpatients seen by general physicians. Outcome measures were the numbers of investigations and of patient reviews. The telemedicine group did not differ significantly from the 150 patients seen face to face by neurologists in hospital clinics in terms of either the number of investigations or the number of reviews they received. Patients from the RCT seen face to face had significantly fewer investigations but a similar number of reviews to the other 150 patients seen face to face by neurologists (the disparity in the number of investigations may explain the negative result for telemedicine in that RCT). Patients with neurological symptoms assessed by general physicians had significantly more investigations and were reviewed significantly more often than all the other groups. Patients from the RCT seen by telemedicine were not managed significantly differently from those seen face to face by neurologists in hospital clinics but had significantly fewer investigations and follow-ups than those patients managed by general physicians. The results suggest that management of new neurological outpatients by neurologists using telemedicine is similar to that by neurologists using a face-to-face consultation, and is more efficient than management by general physicians.

scholarly journals Use of Tablet Video for Delivery of Neonatal Discharge Instructions to First-Time Parents

2021 ◽  
Vol 53 (2) ◽  
pp. 145-147
Author(s):  
Kristine L. Cece ◽  
Jane E. Chargot ◽  
Micheleen Hashikawa ◽  
Melissa A. Plegue ◽  
Katherine J. Gold
Keyword(s):  
Randomized Controlled Trial ◽  
Patient Satisfaction ◽  
Controlled Trial ◽  
Patient Perceptions ◽  
Discharge Instructions ◽  
Face To Face ◽  
Randomized Controlled ◽  
Use Of Technology ◽  
Video Group ◽  
First Time

Background and Objectives: While video discharge instructions have been shown to improve retention of information and patient satisfaction, data are limited regarding patient perceptions of video tools. Methods: We conducted a randomized controlled trial to assess self-rated comprehension and overall satisfaction with video versus face-to-face neonatal discharge instructions in first-time mothers. Results: Video instructions were no different from face-to-face instructions, though there was a nonsignificant increase in confidence in caring for their newborn in the video group. Conclusions: Broader use of technology may allow for a more standardized approach to patient education and improve efficiency for clinicians, without compromising patient satisfaction and confidence in caring for themselves and their dependents.

Study Protocol for a Randomized Controlled Trial to Evaluate the Effectiveness of a Serious Game Targeting Interpersonal Emotion Regulation in Early Adolescents

2021 ◽  
Author(s):  
Gloria Mittmann ◽  
Sonja Zehetmayer ◽  
Beate Schrank
Keyword(s):  
Randomized Controlled Trial ◽  
Emotion Regulation ◽  
Peer Relationships ◽  
Controlled Trial ◽  
Early Adolescents ◽  
Serious Game ◽  
Positive Interactions ◽  
Control Group ◽  
Randomized Controlled ◽  
Interpersonal Emotion Regulation

Abstract Background: Adaptive interpersonal emotion regulation (iER) is a vital tool for positive relations. During early adolescence, peer relations become increasingly important, making this age group a relevant target group for interventions promoting positive interactions with each other, yet no evidence-based intervention exists for early adolescents specifically.Methods: This randomized controlled trial (RCT) aims to test effectiveness and feasibility of a serious game training iER skills in early adolescents by comparing outcomes with a control group playing a game without psychoeducational content in a pre- and post-test design. German- and English-speaking early adolescents (10-14 years) are eligible for participation. IER skills improvement as assessed by a vignette task is the primary outcome and will be analysed with a chi-square test. Secondary outcomes include feasibility and acceptability, emotional competence, personal emotion regulation, gender, and sex.Discussion: This RCT will test whether playing a serious game about iER strategies results in an improvement of iER skills and whether the game is feasible and acceptable for early adolescents with the ultimate aim to implement the game in schools and help early adolescents achieve positive peer relationships.Trial registration: ClinicalTrials.gov, NCT04808102, Registered 19 March 2021, https://register.clinicaltrials.gov/

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