scholarly journals An App-Based Intervention for Adolescents Exposed to Cyberbullying in Norway: Protocol for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Sabine Kaiser ◽  
Monica Martinussen ◽  
Frode Adolfsen ◽  
Kyrre Breivik ◽  
Henriette Kyrrestad
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Evaluation Studies ◽  
Well Being ◽  
Mobile App ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND Adolescents exposed to negative online events are at high risk to develop mental health problems. Little is known about what is effective for treatment in this group. NettOpp is a new mobile app for adolescents who have been exposed to cyberbullying or negative online experiences in Norway. OBJECTIVE The aim of this paper is to provide a description of the content of the intervention and about a randomized controlled trial that will be conducted to examine the effectiveness of NettOpp. This protocol is written in accordance with the Spirit 2013 Checklist. METHODS An effectiveness study with a follow-up examination after 3 months will be conducted to evaluate the mobile app. Adolescents will be recruited through schools and will be randomly assigned to the intervention (NettOpp) group and a waiting-list control group. The adolescents (aged 11 to 16 years) will respond to self-report questionnaires on the internet. Primary outcomes will be changes in mental health assessed with the Strengths and Difficulties Questionnaire, the WHO-Five Well-being Index, and the Child and Adolescent Trauma Screen. RESULTS Recruitment will start in January 2022. The results from this study will be available in 2023. CONCLUSIONS There are few published evaluation studies on app-based interventions. This project and its publications will contribute new knowledge to the field. CLINICALTRIAL ClinicalTrials.gov NCT04176666; https://clinicaltrials.gov/ct2/show/NCT04176666 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/31789

scholarly journals An App-Based Intervention for Adolescents Exposed to Cyberbullying in Norway: Protocol for a Randomized Controlled Trial

10.2196/31789 ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. e31789
Author(s):  
Sabine Kaiser ◽  
Monica Martinussen ◽  
Frode Adolfsen ◽  
Kyrre Breivik ◽  
Henriette Kyrrestad
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Evaluation Studies ◽  
Well Being ◽  
Mobile App ◽  
Self Report ◽  
Control Group ◽  
Randomized Controlled

Background Adolescents exposed to negative online events are at high risk to develop mental health problems. Little is known about what is effective for treatment in this group. NettOpp is a new mobile app for adolescents who have been exposed to cyberbullying or negative online experiences in Norway. Objective The aim of this paper is to provide a description of the content of the intervention and about a randomized controlled trial that will be conducted to examine the effectiveness of NettOpp. This protocol is written in accordance with the Spirit 2013 Checklist. Methods An effectiveness study with a follow-up examination after 3 months will be conducted to evaluate the mobile app. Adolescents will be recruited through schools and will be randomly assigned to the intervention (NettOpp) group and a waiting-list control group. The adolescents (aged 11 to 16 years) will respond to self-report questionnaires on the internet. Primary outcomes will be changes in mental health assessed with the Strengths and Difficulties Questionnaire, the WHO-Five Well-being Index, and the Child and Adolescent Trauma Screen. Results Recruitment will start in January 2022. The results from this study will be available in 2023. Conclusions There are few published evaluation studies on app-based interventions. This project and its publications will contribute new knowledge to the field. Trial Registration ClinicalTrials.gov NCT04176666; https://clinicaltrials.gov/ct2/show/NCT04176666 International Registered Report Identifier (IRRID) PRR1-10.2196/31789

scholarly journals A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial

10.2196/24264 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e24264
Author(s):  
Hayley Wright ◽  
Faith Martin ◽  
Wendy Clyne ◽  
Cain C T Clark ◽  
Michael McGillion ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Wait List ◽  
Care Providers ◽  
Randomized Controlled ◽  
Cancer Support

Background During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. Objective We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. Methods Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. Results All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. Conclusions This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. Trial Registration ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 International Registered Report Identifier (IRRID) DERR1-10.2196/24264

Effects of the Satir Model on Mental Health: A Randomized Controlled Trial

2018 ◽  
Vol 29 (7) ◽  
pp. 775-785 ◽  
Author(s):  
Way Kwok-Wai Lau ◽  
Pamela Pui-Yu Leung ◽  
Catherine Lai-Ping Chung
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Intervention Group ◽  
Health Problems ◽  
Control Group ◽  
Mediation Analyses ◽  
Randomized Controlled ◽  
The Relationship

Objective: This randomized controlled trial examined the effect of an intensive experiential workshop based on the Satir growth model (SGM) that aims at cultivating self-transformation. Method: Ninety-six adult participants were randomly assigned to the intervention group (52 participants) or the wait-list control group. The role of self-transformation, measured by the Perceived Self-Transformation Scale, in the relationship between affects and mental health problems was examined using mediation analyses. Results: After the workshop, the intervention group demonstrated higher levels of self-transformation (η2 = .308, p < .001), as well as significant improvement ( p < .001) in positive (η2 = .557) and negative (η2 = .293) affects, self-esteem (η2 = .538), spirituality (η2 = .473), and mental health problems (η2 = .386). Importantly, increased self-transformation after the workshop partially mediated the relationship between reduced negative affect and mental health problems in the intervention group (indirect effect: β = 0.163, 95% confidence interval [0.035, 0.343]). Conclusion: Findings of this study suggest that the SGM-based intervention can be effective in ameliorating mental health problems.

scholarly journals Mental Health Promotion Among University Students Using Text Messaging: Protocol for a Randomized Controlled Trial of a Mobile Phone–Based Intervention (Preprint)

2018 ◽  
Author(s):  
Kristin Thomas ◽  
Marcus Bendtsen
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Well Being ◽  
Positive Mental Health ◽  
Control Group ◽  
Randomized Controlled

BACKGROUND There is a growing understanding that well-being and mental illness are 2 separate dimensions of mental health. High well-being is associated with decreased risk of disease and mental illness and increased longevity. OBJECTIVE This study aims to test the efficacy of a mobile phone–based intervention on positive mental health. METHODS We are conducting a 2-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (eg, university websites). Participants will be randomly allocated to either an intervention (fully automated mobile phone–based mental health intervention) or control group (treatment as usual). The primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale). Outcomes will be investigated at baseline, at 3, 6, and 12 months after randomization. Mediators (positive emotions and thoughts) will be investigated at baseline, midintervention, and at follow-ups using 2 single face-valid items. RESULTS Data will be collected between autumn 2018 and spring 2019. Results are expected to be published in 2020. CONCLUSIONS Strengths of the study include the use of a validated comprehensive instrument to measure positive mental health. Mechanisms of change are also investigated. A potential challenge could be recruitment; however, by setting a prolonged recruitment period, we believe that the study will recruit a sufficient sample. CLINICALTRIAL International Standard Randomized Controlled Trial Number: 54748632; http://www.isrctn.com/ ISRCTN54748632 INTERNATIONAL REGISTERED REPOR PRR1-10.2196/12396

scholarly journals A Digital Program (Hope) for People Living With Cancer During the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Hayley Wright ◽  
Faith Martin ◽  
Wendy Clyne ◽  
Cain C T Clark ◽  
Michael McGillion ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Wait List ◽  
Care Providers ◽  
Randomized Controlled ◽  
Cancer Support

BACKGROUND During the COVID-19 lockdown period in the United Kingdom that began on March 23, 2020, more than a quarter of a million people with cancer reported worsening mental health. Help to Overcome Problems Effectively (Hope) is a self-management program for people with cancer, designed to provide support for distress, unmet needs, and poor psychological health. In light of social distancing during the COVID-19 pandemic, digital delivery of the Hope Programme has become ever more vital for people with cancer. Previous pre-post studies of the digital Hope Programme have found reduced anxiety and depression and improved well-being for people with cancer. However, evaluation of this evidence has been limited by the lack of a control group in these previous studies. OBJECTIVE We now present a protocol for a feasibility randomized controlled trial of the digital Hope Programme for people with cancer during the COVID-19 pandemic. Primary outcomes will be recruitment, dropout, and adherence rates, and estimations of sample and effect size. To detect signals of efficacy, secondary outcomes will be participant mental health and well-being. METHODS Participants will be recruited by Macmillan Cancer Support (MCS) through their social media networks. The study will employ a feasibility wait-list randomized controlled trial (RCT) design, with people with cancer being randomized to join the digital Hope Programme immediately (intervention group [IG]) or join a 6-week waiting list (wait-list control group [WLCG]) with a 1:1 allocation ratio. Participants will complete digital measures of depression, anxiety, mental well-being, and confidence in managing their own health. Online questionnaires will be administered preprogram and 6 weeks postprogram. RESULTS All people who had requested access to the Hope Programme from MCS (N=61) will be invited to participate in the trial. Baseline data collection commenced in April 2020, and the Hope Programme began for the IG in May 2020 and for the WLCG in June 2020. Postprogram data collection was completed by the end of August 2020. CONCLUSIONS This feasibility study will provide data to inform the design of a future definitive trial. Wider-scale provision of the digital Hope Programme has potential to improve the lives of thousands of people with cancer and reduce the burden on health care providers during these unprecedented times. CLINICALTRIAL ISRCTN Registry ISRCTN79623250; http://www.isrctn.com/ISRCTN79623250 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/24264

scholarly journals Mental Health Promotion Among University Students Using Text Messaging: Protocol for a Randomized Controlled Trial of a Mobile Phone–Based Intervention

10.2196/12396 ◽  
2019 ◽  
Vol 8 (8) ◽  
pp. e12396 ◽  
Author(s):  
Kristin Thomas ◽  
Marcus Bendtsen
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Mobile Phone ◽  
Controlled Trial ◽  
Well Being ◽  
Positive Mental Health ◽  
Control Group ◽  
Randomized Controlled

Background There is a growing understanding that well-being and mental illness are 2 separate dimensions of mental health. High well-being is associated with decreased risk of disease and mental illness and increased longevity. Objective This study aims to test the efficacy of a mobile phone–based intervention on positive mental health. Methods We are conducting a 2-armed randomized controlled trial of university students in Sweden. Recruitment will last for 6 months by digital advertising (eg, university websites). Participants will be randomly allocated to either an intervention (fully automated mobile phone–based mental health intervention) or control group (treatment as usual). The primary outcome will be self-assessed positive mental health (Mental Health Continuum Short Form). Secondary outcomes will be self-assessed depression anxiety symptomatology (Hospital Anxiety Depression Scale). Outcomes will be investigated at baseline, at 3, 6, and 12 months after randomization. Mediators (positive emotions and thoughts) will be investigated at baseline, midintervention, and at follow-ups using 2 single face-valid items. Results Data will be collected between autumn 2018 and spring 2019. Results are expected to be published in 2020. Conclusions Strengths of the study include the use of a validated comprehensive instrument to measure positive mental health. Mechanisms of change are also investigated. A potential challenge could be recruitment; however, by setting a prolonged recruitment period, we believe that the study will recruit a sufficient sample. Trial Registration International Standard Randomized Controlled Trial Number: 54748632; http://www.isrctn.com/ ISRCTN54748632 International Registered Report Identifier (IRRID) PRR1-10.2196/12396

scholarly journals The Influence of Connectedness to Nature on Psychological Well-Being: Evidence from the Randomized Controlled Trial Play&Grow

Challenges ◽  
2021 ◽  
Vol 12 (1) ◽  
pp. 12
Author(s):  
Tanja Sobko ◽  
Gavin T. L. Brown
Keyword(s):  
Randomized Controlled Trial ◽  
Young Children ◽  
Psychological Health ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Well Being ◽  
Path Model ◽  
Psychological Well Being ◽  
Connectedness To Nature ◽  
Randomized Controlled

Urbanized children today have fewer opportunities to interact with nature which may lead to a greater risk of mental health problems. The objective of this randomized controlled trial was to investigate which particular changes in connectedness to nature (CN) would improve psychological well-being (PW) in young children. Six hundred and thirty-nine preschoolers (52.0% boys, age 34.9 ± 9.5 months) participated in Play&Grow, an early environmental education intervention. Children’s CN and PW were evaluated by parents before and after the program with validated measures; the CNI-PPC (four factors) and the SDQ, Strength and Difficulties questionnaire (five factors), respectively. The effectiveness of the intervention on the primary outcomes (CN, PW) as well as the relationship between them was analyzed in a repeated measures path model with intervention status as a causal predictor. Specific CN factors consistently increased ProSocial behavior and reduced Hyperactivity and Emotional problems. In summary, this study showed that the previously reported impact shifted from the total CN score to the specific CN factors. The Play&Grow intervention positively increased children’s CN and improved some aspects of psychological well-being in children which is a preliminary evidence of developmental benefits of connecting young children with nature. Our results indicate promising direction of action for the improvement of families’ psychological health.

scholarly journals COMmunity PARticipation through Education (COMPARE): effectiveness of supported education for students with mental health problems, a mixed methods study – study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jacomijn Hofstra ◽  
Jorien van der Velde ◽  
Petra Jannette Havinga ◽  
Lies Korevaar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Mixed Methods ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Health Problems ◽  
Secondary Outcome ◽  
Study Success ◽  
Randomized Controlled ◽  
Supported Education

Abstract Background The onset of mental health problems generally occurs between the ages of 16 and 23 – the years in which young people follow post-secondary education, which is a major channel in our society to prepare for a career and enhance life goals. Several studies have shown that students with mental health problems have a higher chance of early school leaving. Supported Education services have been developed to support students with mental health problems to remain at school. The current project aims to study the effect of an individually tailored Supported Education intervention on remaining at school, study success, and satisfaction of students with mental health problems studying at an institute for intermediate vocational education and a university of applied sciences in the Netherlands. Methods/design The design combines quantitative research (Randomized Controlled Trial; RCT) with qualitative research (monitoring, interviews, focus groups). One hundred students with mental health problems recruited from the two educational institutes will be randomly allocated to either the intervention or control condition. The students in the intervention condition receive the Supported Education intervention given by a Supported Education specialist, the students in the active control condition receive support as usual plus advice from a trained staff member on potential supportive resources regarding studying with mental health problems. The primary outcome ‘remaining at school’, and the secondary outcome ‘study success’ will be determined using data from the school’s administration. The secondary outcome ‘student satisfaction’ and other variables that will be studied in a more exploratory way, such as self-efficacy and study skills, will be determined through online questionnaires at baseline, at 6 and at 12 months follow-up. Focus groups and interviews with the students and Supported Education specialists will be carried out to complement the trial. Discussion This RCT is the first to assess the effect of Supported Education on remaining at school, next to study success and student satisfaction among students with mental health problems. The use of a mixed-methods design will result in a thorough evaluation of the effect of the intervention. Issues regarding the influx and possible attrition of students in the follow-up are discussed. Trial registration The study was registered with Trialregister.nl, no. NL8349, date registered: February 4th 2020. Register name: Community participation through education. Effectiveness of Supported Education for youth with mental health problems, a mixed methods study – Study protocol for a Randomized Controlled Trial. Protocol Version: 3, date: May 28th, 2021.

scholarly journals Foam Rolling Elicits Neuronal Relaxation Patterns Distinct from Manual Massage: A Randomized Controlled Trial

2021 ◽  
Vol 11 (6) ◽  
pp. 818
Author(s):  
Yann Kerautret ◽  
Aymeric Guillot ◽  
Sébastien Daligault ◽  
Franck Di Rienzo
Keyword(s):  
Skin Conductance ◽  
Muscle Pain ◽  
Controlled Trial ◽  
Muscle Relaxation ◽  
Well Being ◽  
Self Report ◽  
Controlled Study ◽  
Control Group ◽  
Foam Rolling ◽  
Randomized Controlled

The present double-blinded, randomized controlled study sought to compare the effects of a full-body manual massage (MM) and a foam rolling (FR) intervention on subjective and objective indexes of performance and well-being. A total of 65 healthy individuals were randomly allocated to an FR, MM, or a control group who received a cognitively oriented relaxation routine. Self-report ratings of perceived anxiety, muscle relaxation, and muscle pain were used to index changes in affect and physical sensations. The sit-and-reach and toe-touch tests, as well as a mental calculation task, were used to index motor and cognitive performances, respectively. We also conducted resting-state electroencephalography and continuous skin conductance recordings before and after the experimental intervention. Both FR and MM groups exhibited neural synchronization of alpha and beta oscillations during the posttest. Skin conductance increased from the pretest to the posttest in the relaxation group, but decreased in the FR group. All interventions improved range of motion, although only the MM group outperformed the relaxation group for the toe-touch performance. MM was associated with reduced muscle pain and increased muscle relaxation. Reduced perceived anxiety after the intervention was observed in the FR group only. Overall, MM and FR both improved objective and subjective indexes of performance and well-being. Differences between the two massage interventions are discussed in relation to the effects of pressure stimulation on autonomic regulations and the proactive vs. retroactive nature of FR, compared to MM.

Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep and Well-being: A Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
The Impact ◽  
Insomnia Symptoms

BACKGROUND The COVID-19 Pandemic led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remains unknown. OBJECTIVE Here, we present the framework and protocol for a novel study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life. METHODS The protocol details a two-arm randomized controlled trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent a deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic are randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0), and at weeks 1-6, 12, 28, and 56. RESULTS The trial began enrollment June 3, 2020 and closed enrollment June 17, 2021. As of October 2021, 49 participants have been randomized to either immediate treatment or a 28-week waitlist. 23 participants are still active in the protocol. CONCLUSIONS To our knowledge, this protocol would be represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 Pandemic. The findings of this study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being. CLINICALTRIAL NCT04409743

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