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 ◽  
...  

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

2020 ◽  
Author(s):  
Hayley Wright ◽  
Faith Martin ◽  
Wendy Clyne ◽  
Cain C T Clark ◽  
Michael McGillion ◽  
...  

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


10.2196/31789 ◽  
2021 ◽  
Vol 10 (11) ◽  
pp. e31789
Author(s):  
Sabine Kaiser ◽  
Monica Martinussen ◽  
Frode Adolfsen ◽  
Kyrre Breivik ◽  
Henriette Kyrrestad

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


2018 ◽  
Author(s):  
Kristin Thomas ◽  
Marcus Bendtsen

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


2021 ◽  
Author(s):  
Sabine Kaiser ◽  
Monica Martinussen ◽  
Frode Adolfsen ◽  
Kyrre Breivik ◽  
Henriette Kyrrestad

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


10.2196/12396 ◽  
2019 ◽  
Vol 8 (8) ◽  
pp. e12396 ◽  
Author(s):  
Kristin Thomas ◽  
Marcus Bendtsen

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


2021 ◽  
Author(s):  
Kathleen P. O'Hora ◽  
Raquel A. Osorno ◽  
Dena Sadeghi-Bahmani ◽  
Mateo Lopez ◽  
Allison Morehouse ◽  
...  

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


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ann-Marie Küchler ◽  
Dana Schultchen ◽  
Olga Pollatos ◽  
Morten Moshagen ◽  
David D. Ebert ◽  
...  

Abstract Background College is an exciting but also challenging time with an increased risk for mental health issues. Only a minority of the college students concerned get professional help, a problem that might be improvable by internet- and mobile-based interventions (IMIs). However, adherence of IMIs is a concern. While guidance might be a solution, it is resource-intensive, derailing potential implementation on population level. The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with “on demand” and no guidance. The second aim is to examine potential moderators and mediators, contributing to the questions of “how” and “for whom” such interventions work. Methods In this three-armed randomized controlled trial, both an unguided and “guidance on demand” (GoD) condition of StudiCare-M are compared to a waitlist control group. StudiCare-M is based on principles of acceptance and commitment therapy and stress management and consists of 7 modules plus two booster sessions. Participants in the GoD condition may ask their e-coach for support whenever needed. A total of 387 college students with moderate to low mindfulness are recruited at 15+ cooperating universities in Germany, Austria, and Switzerland via circular emails. Assessments take place before as well as 1, 2, and 6 months after randomization. The primary outcome is mindfulness. Secondary outcomes include stress, depression, anxiety, interoception, presenteeism, wellbeing, intervention satisfaction, adherence, and potential side effects. Among examined moderators and mediators are sociodemographic variables, pre-treatment symptomatology, treatment expectancy, self-efficacy, cognitive fusion, emotion regulation, and alexithymia. All data will be analyzed according to intention-to-treat (ITT) principles. Discussion Providing effective interventions to help college students become more resilient can make a valuable contribution to the health and functionality of future society. If effective under the condition of minimal or no guidance, StudiCare-M offers a low-threshold potentially resource-efficient possibility to enhance college student mental health on a population level. Moderation- and mediation analyses will deliver further insights for optimization of target groups and intervention content. Trial registration WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register DRKS00014774. Registered on 18 May 2018.


2018 ◽  
Vol 5 ◽  
Author(s):  
A. Akol ◽  
F. Makumbi ◽  
J. N. Babirye ◽  
J. S. Nalugya ◽  
S. Nshemereirwe ◽  
...  

Background.Integrating child and adolescent mental health (CAMH) into primary health care (PHC) using the WHO mental health gap action program (mhGAP) is recommended for closing a mental health treatment gap in low- and middle-income countries, but PHC providers have limited ability to detect CAMH disorders. We aimed to evaluate the effect of PHC provider mhGAP training on CAMH disorder identification in Eastern Uganda.Methods.Thirty-six PHC clinics participated in a randomized controlled trial which compared the proportion of intervention (n= 18) to control (n= 18) clinics with a non-epilepsy CAMH diagnosis over 3 consecutive months following mhGAP-oriented CAMH training. Fisher's exact test and logistic regression based on intention to treat principles were applied. (clinicaltrials.gov registration NCT02552056).Results.Nearly two thirds (63.8%, 23/36) of all clinics identified and recorded at least one non-epilepsy CAMH diagnosis from 40 692 clinic visits of patients aged 1–18 recorded over 4 months. The proportion of clinics with a non-epilepsy CAMH diagnosis prior to training was 27.7% (10/36, similar between study arms). Training did not significantly improve intervention clinics’ non-epilepsy CAMH diagnosis (13/18, 72.2%) relative to the control (7/18, 38.9%) arm,p= 0.092. The odds of identifying and recording a non-epilepsy CAMH diagnosis were 2.5 times higher in the intervention than control arms at the end of 3 months of follow-up [adj.OR 2.48; 95% CI (1.31–4.68);p= 0.005].Conclusion.In this setting, mhGAP CAMH training of PHC providers increases PHC clinics’ identification and reporting of non-epilepsy CAMH cases but this increase did not reach statistical significance.


2013 ◽  
Vol 23 (Supplement 1) ◽  
pp. 32-53

SYR 2013 Accepted Poster abstracts: 1. Benefits of Yoga as a Wellness Practice in a Veterans Affairs (VA) Health Care Setting: If You Build It, Will They Come? 2. Yoga-based Psychotherapy Group With Urban Youth Exposed to Trauma. 3. Embodied Health: The Effects of a Mind-Body Course for Medical Students. 4. Interoceptive Awareness and Vegetable Intake After a Yoga and Stress Management Intervention. 5. Yoga Reduces Performance Anxiety in Adolescent Musicians. 6. Designing and Implementing a Therapeutic Yoga Program for Older Women With Knee Osteoarthritis. 7. Yoga and Life Skills Eating Disorder Prevention Among 5th Grade Females: A Controlled Trial. 8. A Randomized, Controlled Trial Comparing the Impact of Yoga and Physical Education on the Emotional and Behavioral Functioning of Middle School Children. 9. Feasibility of a Multisite, Community based Randomized Study of Yoga and Wellness Education for Women With Breast Cancer Undergoing Chemotherapy. 10. A Delphi Study for the Development of Protocol Guidelines for Yoga Interventions in Mental Health. 11. Impact Investigation of Breathwalk Daily Practice: Canada-India Collaborative Study. 12. Yoga Improves Distress, Fatigue, and Insomnia in Older Veteran Cancer Survivors: Results of a Pilot Study. 13. Assessment of Kundalini Mantra and Meditation as an Adjunctive Treatment With Mental Health Consumers. 14. Kundalini Yoga Therapy Versus Cognitive Behavior Therapy for Generalized Anxiety Disorder and Co-Occurring Mood Disorder. 15. Baseline Differences in Women Versus Men Initiating Yoga Programs to Aid Smoking Cessation: Quitting in Balance Versus QuitStrong. 16. Pranayam Practice: Impact on Focus and Everyday Life of Work and Relationships. 17. Participation in a Tailored Yoga Program is Associated With Improved Physical Health in Persons With Arthritis. 18. Effects of Yoga on Blood Pressure: Systematic Review and Meta-analysis. 19. A Quasi-experimental Trial of a Yoga based Intervention to Reduce Stress and Promote Health and Well-being Among Middle School Educators. 20. A Systematic Review of Yoga-based Interventions for Objective and Subjective Balance Measures. 21. Disparities in Yoga Use: A Multivariate Analysis of 2007 National Health Interview Survey Data. 22. Implementing Yoga Therapy Adapted for Older Veterans Who Are Cancer Survivors. 23. Randomized, Controlled Trial of Yoga for Women With Major Depressive Disorder: Decreased Ruminations as Potential Mechanism for Effects on Depression? 24. Yoga Beyond the Metropolis: A Yoga Telehealth Program for Veterans. 25. Yoga Practice Frequency, Relationship Maintenance Behaviors, and the Potential Mediating Role of Relationally Interdependent Cognition. 26. Effects of Medical Yoga in Quality of Life, Blood Pressure, and Heart Rate in Patients With Paroxysmal Atrial Fibrillation. 27. Yoga During School May Promote Emotion Regulation Capacity in Adolescents: A Group Randomized, Controlled Study. 28. Integrated Yoga Therapy in a Single Session as a Stress Management Technique in Comparison With Other Techniques. 29. Effects of a Classroom-based Yoga Intervention on Stress and Attention in Second and Third Grade Students. 30. Improving Memory, Attention, and Executive Function in Older Adults with Yoga Therapy. 31. Reasons for Starting and Continuing Yoga. 32. Yoga and Stress Management May Buffer Against Sexual Risk-Taking Behavior Increases in College Freshmen. 33. Whole-systems Ayurveda and Yoga Therapy for Obesity: Outcomes of a Pilot Study. 34. Women's Phenomenological Experiences of Exercise, Breathing, and the Body During Yoga for Smoking Cessation Treatment. 35. Mindfulness as a Tool for Trauma Recovery: Examination of a Gender-responsive Trauma-informed Integrative Mindfulness Program for Female Inmates. 36. Yoga After Stroke Leads to Multiple Physical Improvements. 37. Tele-Yoga in Patients With Chronic Obstructive Pulmonary Disease and Heart Failure: A Mixed-methods Study of Feasibility, Acceptability, and Safety. 38. Effects of an Ashtanga Yoga-based Health and Wellness Curriculum on Physical and Emotional Well-being, Engagement Toward School, and Academic Performance of K-6 Students. 39. Yoga as a Facilitator for Participation Following an 8-week Yoga for Individuals With Chronic Stroke. 40. Standardization of Design and Reporting of Yoga Interventions for Musculoskeletal Conditions: A Delphi Approach. 41. Creating S.P.A.C.E. Through Yoga: Africa Yoga Project Teachers Promote Personal Transformation, Peaceful Communities, and Purpose-filled Service.


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