A Brief, Mobile Intervention to Decrease Depression and Loneliness and Improve Relationship Quality During the Covid-19 Pandemic

2021 ◽  
Vol 40 (5) ◽  
pp. 422-447
Author(s):  
Jonathan W. Kanter ◽  
Michael G. Nash ◽  
Adam Kuczynski ◽  
Daniel C. Rosen
Keyword(s):  
Social Relationships ◽  
Controlled Trial ◽  
Text Message ◽  
Well Being ◽  
Social Psychological ◽  
Randomized Controlled ◽  
Mobile Intervention ◽  
Study Intervention ◽  
Mental Well Being

Introduction: Effective, scalable interventions to address depression and loneliness and improve the quality of social relationships are needed for public health in pandemic and non-pandemic contexts. Towards this end, a randomized, controlled trial tested a mobile-based intervention, derived from social psychological and relationship science, for improving relational well-being and decreasing depression and loneliness. Methods: Participants were randomly assigned to either intervention (n = 719) or assessment only (n = 701) conditions and completed daily diary surveys for 28 days in the midst of the first wave of the Covid-19 pandemic. In the middle 14 days of the study, intervention participants received daily text-message suggestions for improving relational and mental well-being. Results: Results indicated that the intervention decreased depression and loneliness and improved relationships during the intervention period but these changes were not sustained when the intervention ceased. Discussion: Results are encouraging in that evidence-based suggestions can be scaled effectively but additional efforts are required to sustain improvements over time.

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

scholarly journals UPRIGHT, a resilience-based intervention to promote mental well-being in schools: study rationale and methodology for a European randomized controlled trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Carlota Las Hayas ◽  
◽  
Irantzu Izco-Basurko ◽  
Ane Fullaondo ◽  
Silvia Gabrielli ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mental Disorders ◽  
Controlled Trial ◽  
Well Being ◽  
Simulation Modelling ◽  
European Regions ◽  
Horizon 2020 ◽  
Randomized Controlled ◽  
Research And Innovation ◽  
Mental Well Being

Abstract Background Adolescence is crucial period for laying the foundations for healthy development and mental well-being. The increasing prevalence of mental disorders amongst adolescents makes promotion of mental well-being and prevention interventions at schools important. UPRIGHT (Universal Preventive Resilience Intervention Globally implemented in schools to improve and promote mental Health for Teenagers) is designed as a whole school approach (school community, students and families) to promote a culture of mental well-being and prevent mental disorders by enhancing resilience capacities. The present article aims at describing the rationale, conceptual framework, as well as methodology of implementation and evaluation of the UPRIGHT intervention. Methods UPRIGHT project is a research and innovation project funded by the European Union’s Horizon 2020 Research and Innovation programme under grant agreement No. 754919 (Duration: 48 months). The theoretical framework has been developed by an innovative and multidisciplinary approach using a co-creation process inside the UPRIGHT Consortium (involving seven institutions from Spain, Italy, Poland, Norway, Denmark, and Iceland). Resulted is the UPRIGHT programme with 18 skills related to 4 components: Mindfulness, Coping, Efficacy and Social and Emotional Learning. Among the five Pan-European regions, 34 schools have been currently involved (17 control; 17 intervention) and around 6000 adolescents and their families are foreseen to participate along a 3-year period of evaluation. Effectiveness of the intervention will be evaluated as a randomized controlled trial including quantitative and qualitative analysis in the five Pan-European regions representative of the cultural and socioeconomic diversity. The cost-effectiveness assessment will be performed by simulation modelling methods. Discussion We expect a short- to medium-term improvement of mental well-being in adolescents by enhancing resilience capacities. The study may provide robust evidence on intrapersonal, familiar and social environmental resilience factors promoting positive mental well-being. Trial registration ClinicalTrials.gov Identifier: NCT03951376. Registered 15 May 2019.

scholarly journals A Model of Intervention and Implementation of Quality Building and Quality Control in Childcare Centers to Strengthen the Mental Health and Development of 1-3–Year Olds: Protocol for a Randomized Controlled Trial of Thrive by Three (Preprint)

2020 ◽  
Author(s):  
Ratib Lekhal ◽  
May Britt Drugli ◽  
Turid Suzanne Berg-Nielsen ◽  
Elisabet Solheim Buøen
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Child Development ◽  
Controlled Trial ◽  
Well Being ◽  
High Quality ◽  
Childcare Centers ◽  
Teacher Report ◽  
Randomized Controlled

BACKGROUND Universal, high-quality childcare offers a unique opportunity to prevent developmental trajectories leading to mental health problems. Yet, growing evidence has shown that the process quality of Norwegian childcare centers varies considerably, and that research-based models for quality building are significantly lacking. OBJECTIVE To examine whether a model for quality building in childcare centers, Thrive by Three, increases the quality of child–caregiver interactions, and promotes child development, well-being, and mental health. METHODS The Thrive by Three study is a clustered randomized controlled trial involving 187 toddler groups in childcare centers across 7 municipalities within southern and central Norway. Each center is randomly allocated to the intervention or wait-list control group. Data are collected at 4 points: preintervention (T1), midway (T2), postintervention (T3), and 1-year postintervention (T4). Primary outcomes are changes in childcare quality measured by the Classroom Assessment Scoring System toddler version (CLASS), Student–Teacher Relationship Scale, Short Form (STRS-SF), and Life in Early Childhood Programs (LECP), as well as child development and mental health measured by The Brief Infant Toddler Social and Emotional Assessment (BITSEA, parent and teacher report), the Caregiver–Teacher Report Form (C-TRF), and Child Behavior Checklist (parent report) from the Achenbach System of Empirically Based Assessment (ASEBA) from 1.5 to 5 years, and child well-being measured by the Leiden Inventory for Child’s Well-Being in Day Care (LICW-D). Secondary outcomes are child cortisol levels, assessed in a subsample of 372 children. RESULTS As of August 2020, a total of 1531 children and 769 staff from 187 toddler groups were recruited. Because of turnover, the recruitment of staff will be ongoing until August 2020. As of January 2020, the intervention group has been working with Thrive by Three for 1.5 years. Data at T1, T2, and T3 from both the intervention and control groups have been completed and T4 will be completed in August 2020. CONCLUSIONS This study makes an important contribution to the field of quality building in childcare centers. The results will provide greater insight into how high quality can be obtained and the effects of high-quality early childcare on child mental health. This in turn will be significant for policymakers and to the Norwegian society at large. CLINICALTRIAL ClinicalTrials.gov NCT03879733; https://clinicaltrials.gov/ct2/show/NCT03879733 and Norwegian Research Council 260624/H10; https://prosjektbanken.forskningsradet.no/#/project/NFR/260624/Sprak=en INTERNATIONAL REGISTERED REPORT DERR1-10.2196/17726

scholarly journals Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial

10.2196/21335 ◽  
2021 ◽  
Vol 23 (2) ◽  
pp. e21335
Author(s):  
Amanda Díaz-García ◽  
Alberto González-Robles ◽  
Azucena García-Palacios ◽  
Javier Fernández-Álvarez ◽  
Diana Castilla ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Emotional Disorders ◽  
Controlled Trial ◽  
Well Being ◽  
Effect Sizes ◽  
The Internet ◽  
Positive And Negative Affect ◽  
Randomized Controlled

Background Emotional disorders (EDs) are among the most prevalent mental disorders. Existing evidence-based psychological treatments are not sufficient to reduce the disease burden of mental disorders. It is therefore essential to implement innovative solutions to achieve a successful dissemination of psychological treatment protocols, and in this regard, the use of information and communication technologies such as the internet can be very useful. Furthermore, the literature suggests that not everyone with an ED receives the appropriate treatment. This situation has led to the development of new intervention proposals based on the transdiagnostic perspective, which attempts to address the underlying processes common to EDs. Most of these transdiagnostic interventions focus primarily on downregulating negative affectivity (NA), and less attention has been paid to strengths and the upregulation of positive affectivity, despite its importance for well-being and mental health. Objective This study aims to evaluate the efficacy of a transdiagnostic internet-based treatment for EDs in a community sample. Methods A 3-armed randomized controlled trial was conducted. A total of 216 participants were randomly assigned to a transdiagnostic internet-based protocol (TIBP), a TIBP+ positive affect (PA) component, or a waiting list (WL) control group. The treatment protocol contained core components mainly addressed to downregulate NA (ie, present-focused emotional awareness and acceptance, cognitive flexibility, behavioral and emotional avoidance patterns, and interoceptive and situational exposure) as well as a PA regulation component to promote psychological strengths and enhance well-being. Data on depression, anxiety, quality of life, neuroticism and extraversion, and PA/NA before and after treatment were analyzed. Expectations and opinions of treatment were also analyzed. Results Within-group comparisons indicated significant pre-post reductions in the two experimental conditions. In the TIBP+PA condition, the effect sizes were large for all primary outcomes (d=1.42, Beck Depression Inventory [BDI-II]; d=0.91, Beck Anxiety Inventory [BAI]; d=1.27, Positive and Negative Affect Schedule-Positive [PANAS-P]; d=1.26, Positive and Negative Affect Schedule-Negative [PANAS-N]), whereas the TIBP condition yielded large effect sizes for BDI-II (d=1.19) and PANAS-N (d=1.28) and medium effect sizes for BAI (d=0.63) and PANAS-P (d=0.69). Between-group comparisons revealed that participants who received one of the two active treatments scored better at posttreatment than WL participants. Although there were no statistically significant differences between the two intervention groups on the PA measure, effect sizes were consistently larger in the TIBP+PA condition than in the standard transdiagnostic protocol. Conclusions Overall, the findings indicate that EDs can be effectively treated with a transdiagnostic intervention via the internet, as significant improvements in depression, anxiety, and quality of life measures were observed. Regarding PA measures, promising effects were found, but more research is needed to study the role of PA as a therapeutic component. Trial Registration ClinicalTrials.gov NCT02578758; https://clinicaltrials.gov/ct2/show/NCT02578758 International Registered Report Identifier (IRRID) RR2-10.1186/s12888-017-1297-z

scholarly journals Gratitude as Mood Mediates the Effects of a 6-Weeks Gratitude Intervention on Mental Well-Being: Post hoc Analysis of a Randomized Controlled Trial

2022 ◽  
Vol 12 ◽  
Author(s):  
Ernst Bohlmeijer ◽  
Jannis Kraiss ◽  
Marijke Schotanus-Dijkstra ◽  
Peter ten Klooster
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Sensitivity Analyses ◽  
Control Group ◽  
Multiple Mediation ◽  
Randomized Controlled ◽  
Gratitude Intervention ◽  
Mental Well Being ◽  
Gratitude Interventions

There is a gap of knowledge about the extent to which gratitude is indeed the working mechanism of change in gratitude interventions aiming to promote mental well-being. This study explores the mediational role of gratitude as mood in the context of a recently conducted randomized controlled trial on the effects of a 6-week gratitude intervention on mental well-being in comparison with a waitlist control group. Gratitude as mood was measured at 2, 4, and 6 weeks. Both simple and multiple mediation models were conducted as well as various sensitivity analyses. Results showed a gradual increase of gratitude as mood during the intervention. The effects of the 6-week gratitude intervention on mental well-being were mediated by increases of gratitude as mood at 4 weeks but not at 2 weeks. These findings suggest a dose-response relationship for gratitude interventions, but more research is warranted.

scholarly journals One-Way and Two-Way Mobile Phone Text Messages for Treatment Adherence Among Patients With HIV: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Dickson Shey Nsagha ◽  
Vincent Verla Siysi ◽  
Same Ekobo ◽  
Thomas Obinchemti Egbe ◽  
Odette Dzemo Kibu
Keyword(s):  
Quality Of Life ◽  
Data Collection ◽  
Text Messaging ◽  
Controlled Trial ◽  
Text Message ◽  
Text Messages ◽  
Randomized Controlled ◽  
The Impact ◽  
Sms Text Messaging

BACKGROUND Incomplete adherence to antiretroviral therapy (ART) is one of the factors that contribute to HIV drug resistance, and it is a major problem for the public health system in controlling the HIV pandemic. There is emerging evidence that SMS can play an important role in health care delivery among patients with HIV on ART, especially in resource-limited settings. OBJECTIVE This paper aims to assess the impact of two-way and one-way SMS text messaging on adherence to HIV treatment. We hypothesized that sending weekly text messages through the one-way and two-way SMS text messaging approach will improve adherence to ART among patients with HIV and improve associated clinical outcomes (quality of life). METHODS A randomized controlled trial is being carried out among participants with HIV who have been on ART for at least one month from an accredited treatment center, namely the Buea Regional Hospital and Kumba District Hospital of South West Region, Cameroon. Participants with HIV, both male and female, aged 21 years and older make up a sample size of 207. The interventions involved the use of mobile phone text messages. Before commencing the intervention, a focus group discussion was carried out among the participants to understand their perception about the use of SMS-based interventions to improve adherence. A total of 246 participants were randomized to receive either a one-way text message (SMS sent to a recipient without recipient sending a reply) or two-way text message (SMS sent to a recipient and recipient sends a reply) or the control (no SMS, only standard care). Data on adherence and quality of life were collected at baseline and after 6 months and will be analyzed using SPSS version 21, while qualitative data will be analyzed using Atlas.ti 7.5. RESULTS Data collection began in September 2019 with focus group discussions and baseline data collection. After 1 month of baseline data collection, the intervention began in October 2019, and postintervention data were collected after 6 months (March 2020). At the end of the study, we will be able to understand the perception of patients toward SMS text messaging–based interventions and also assess the impact of one-way and two-way SMS text messages on treatment adherence among patients with HIV and on associated clinical outcomes (quality of life). CONCLUSIONS The impact of SMS text messaging varies across different settings. The results from this study will determine the perception of patients toward an SMS text messaging–based intervention and its impact on adherence to ART. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16127

scholarly journals Effectiveness and Cost-Effectiveness of Receiving a Hearing Dog on Mental Well-Being and Health in People With Hearing Loss: Protocol for a Randomized Controlled Trial

10.2196/15452 ◽  
2020 ◽  
Vol 9 (4) ◽  
pp. e15452
Author(s):  
Lucy Stuttard ◽  
Catherine Hewitt ◽  
Caroline Fairhurst ◽  
Helen Weatherly ◽  
Simon Walker ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Controlled Trial ◽  
Well Being ◽  
The United Kingdom ◽  
Life Years ◽  
Related Quality ◽  
The Impact ◽  
Mental Well Being ◽  
To Receive

Background People with hearing loss, particularly those who lose their hearing in adulthood, are at an increased risk of social isolation, mental health difficulties, unemployment, loss of independence, risk of accidents, and impaired quality of life. In the United Kingdom, a single third-sector organization provides hearing dogs, a specific type of assistance dog trained to provide sound support to people with hearing loss. These dogs may also deliver numerous psychosocial benefits to recipients. This has not previously been fully investigated. Objective The study aims to evaluate the impact of a hearing dog partnership on the lives of individuals with severe or profound hearing loss. Methods A 2-arm, randomized controlled trial will be conducted within the United Kingdom with 162 hearing dog applicants, aged 18 years and older. Participants will be randomized 1:1 using a matched-pairs design to receive a hearing dog sooner than usual (intervention arm: arm B) or to receive a hearing dog within the usual timeframe (comparator arm: arm A). In the effectiveness analysis, the primary outcome is a comparison of mental well-being 6 months after participants in arm B have received a hearing dog (arm A have not yet received a hearing dog), measured using the Short Warwick Edinburgh Mental Well-Being Scale. Secondary outcome measures include the Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, and Work and Social Adjustments Scale. An economic evaluation will assess the cost-effectiveness, including health-related quality-adjusted life years using the EuroQol 5 Dimensions and social care–related quality-adjusted life years. Participants will be followed up for up to 2 years. A nested qualitative study will investigate the impacts of having a hearing dog and how these impacts occur. Results The study is funded by the National Institute for Health Research’s School for Social Care Research. Recruitment commenced in March 2017 and is now complete. A total of 165 participants were randomized. Data collection will continue until January 2020. Results will be published in peer-reviewed journals and at conferences. A summary of the findings will be made available to participants. Ethical approval was received from the University of York’s Department of Social Policy and Social Work Research Ethics Committee (reference SPSW/S/17/1). Conclusions The findings from this study will provide, for the first time, strong and reliable evidence on the impact of having a hearing dog on people’s lives in terms of their quality of life, well-being, and mental health. Trial Registration International Standard Randomised Controlled Trial Number Registry ISRCTN36452009; http://www.isrctn.com/ISRCTN36452009 International Registered Report Identifier (IRRID) DERR1-10.2196/15452

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