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 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 Mobile Health Intervention for Mental Health Promotion Among University Students: Randomized Controlled Trial

10.2196/17208 ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. e17208 ◽  
Author(s):  
Marcus Bendtsen ◽  
Ulrika Müssener ◽  
Catharina Linderoth ◽  
Kristin Thomas
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Controlled Trial ◽  
Intervention Group ◽  
Positive Mental Health ◽  
Control Group ◽  
Depression And Anxiety ◽  
Randomized Controlled

Background High positive mental health, including the ability to cope with the normal stresses of life, work productively, and be able to contribute to one’s community, has been associated with various health outcomes. The role of positive mental health is therefore increasingly recognized in national mental health promotion programs and policies. Mobile health (mHealth) interventions could be a cost-effective way to disseminate positive psychological interventions to the general population. Objective The aim of this study was to estimate the effect of a fully automated mHealth intervention on positive mental health, and anxiety and depression symptomology among Swedish university students using a randomized controlled trial design. Methods A 2-arm, single-blind (researchers), parallel-groups randomized controlled trial with an mHealth positive psychology program intervention group and a relevant online mental health information control group was employed to estimate the effect of the novel intervention. Participants were recruited using digital advertising through student health care centers in Sweden. Inclusion criteria were (1) university students, (2) able to read and understand Swedish, (3) and have access to a mobile phone. Exclusion criteria were high positive mental health, as assessed by the Mental Health Continuum Short Form (MHC-SF), or high depression and anxiety symptomology, as assessed by the Hospital Anxiety Depression Scale (HADS). The primary outcome was positive mental health (MHC-SF), and the secondary outcomes were depression and anxiety symptomatology (HADS). The subscales of MHC-SF were also analyzed as exploratory outcomes. Outcomes were measured 3 months after randomization through questionnaires completed on the participants’ mobile phones. Results A total of 654 participants (median age 25 years), including 510 (78.0%) identifying as female, were randomized to either the intervention (n=348) or control group (n=306). At follow-up, positive mental health was significantly higher in the intervention group compared with the control group (incidence rate ratio [IRR]=1.067, 95% CI 1.024-1.112, P=.002). For both depression and anxiety symptomatology, the intervention group showed significantly lower scores at follow-up compared with the control group (depression: IRR=0.820, 95% CI 0.714-0.942, P=.005; anxiety: IRR=0.899, 95% CI 0.840-0.962, P=.002). Follow-up rates were lower than expected (58.3% for primary outcomes and 52.3% for secondary outcomes); however, attrition analyses did not identify any systematic attrition with respect to baseline variables. Conclusions The mHealth intervention was estimated to be superior to usual care in increasing positive mental health among university students. A protective effect of the intervention was also found on depressive and anxiety symptoms. These findings demonstrate the feasibility of using an automated mobile phone format to enhance positive mental health, which offers promise for the use of mHealth solutions in public mental health promotion. Trial Registration International Standard Randomized Controlled Trial Registry ISRCTN54748632; http://www.isrctn.com/ISRCTN54748632

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

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 Randomized Controlled Trial Evaluating the Effectiveness of a Short Video-Based Educational Program for Improving Mental Health Literacy Among Schoolteachers

2021 ◽  
Vol 12 ◽  
Author(s):  
Junya Ueda ◽  
Satoshi Yamaguchi ◽  
Yasuhiro Matsuda ◽  
Kosuke Okazaki ◽  
Tsubasa Morimoto ◽  
...  
Keyword(s):  
Mental Health ◽  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Educational Program ◽  
Mental Health Literacy ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Educational Group ◽  
Short Video

Background: Mental illness-related stigma represents a barrier to seeking and receiving appropriate mental health care. Mental health literacy (MHL) can improve mental health knowledge, decrease stigmatizing attitudes, and enhance help-seeking behavior. Starting from 2022, mental illness-related education is due to be introduced in high schools in Japan. For this current situation, we conducted a parallel group, randomized controlled trial to examine the effectiveness of MHL educational program for teachers.Methods: The educational program described in this study comprised a 50-min video lesson designed to improve teachers' MHL. All participants were schoolteachers and were assigned either to an educational group or a waitlist control group. The assessment was conducted for both groups twice: first at baseline and then at 1-h post-intervention. The outcome measures for this trial were changes in knowledge, attitudes, and intended behaviors.Results: The educational group showed a greater improvement in knowledge regarding mental health than did the control group. The program was not effective for decreasing stigma toward mental illness. However, the educational group showed an increased intention to assist students with depression.Limitations: No long-term follow-up was implemented, which means the persistence of the educational program's effect could not be determined. Further, we could not report whether the program induced a change in teachers' behaviors regarding providing support for their students.Conclusions: The short video-based MHL educational program could improve schoolteachers' MHL and increase their intention to assist students. These findings can help in the development of similar educational programs in countries/regions experiencing similar issues regarding mental health.

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 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 Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
J. Dubreucq ◽  
M. Faraldo ◽  
M. Abbes ◽  
B. Ycart ◽  
H. Richard-Lepouriel ◽  
...  
Keyword(s):  
Mental Illness ◽  
Randomized Controlled Trial ◽  
Cognitive Therapy ◽  
Social Functioning ◽  
Serious Mental Illness ◽  
Controlled Trial ◽  
Control Group ◽  
Stepped Wedge ◽  
Randomized Controlled ◽  
Cluster Randomized

Abstract Background Self-stigma is highly prevalent in serious mental illness (SMI) and is associated with poorer clinical and functional outcomes. Narrative enhancement and cognitive therapy (NECT) is a group-based intervention combining psychoeducation, cognitive restructuring and story-telling exercises to reduce self-stigma and its impact on recovery-related outcomes. Despite evidence of its effectiveness on self-stigma in schizophrenia-related disorders, it is unclear whether NECT can impact social functioning. Methods This is a 12-centre stepped-wedge cluster randomized controlled trial of NECT effectiveness on social functioning in SMI, compared to treatment as usual. One hundred and twenty participants diagnosed with schizophrenia, bipolar disorder or borderline personality disorder will be recruited across the 12 sites. The 12 centres participating to the study will be randomized into two groups: one group (group 1) receiving the intervention at the beginning of the study (T0) and one group (group 2) being a control group for the first 6 months and receiving the intervention after (T1). Outcomes will be compared in both groups at T0 and T1, and 6-month and 12-month outcomes for groups 1 and 2 will be measured without a control group at T2 (to evaluate the stability of the effects over time). Evaluations will be conducted by assessors blind to treatment allocation. The primary outcome is personal and social performance compared across randomization groups. Secondary outcomes include self-stigma, self-esteem, wellbeing, quality of life, illness severity, depressive symptoms and personal recovery. Discussion NECT is a promising intervention for reducing self-stigma and improving recovery-related outcomes in SMI. If shown to be effective in this trial, it is likely that NECT will be implemented in psychiatric rehabilitation services with subsequent implications for routine clinical practice. Trial registration ClinicalTrials.gov NCT03972735. Trial registration date 31 May 2019.

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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