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Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression.

ABSTRACT: High levels of anxiety and depression are common psychological symptoms among children and adolescents. These symptoms affect young people in multiple life domains and are possible precursors of long-term psychological distress. Despite relatively high prevalence, few children with emotional problems are referred for clinical treatment, indicating the need for systematic prevention. The primary aim of this study is to evaluate an indicated preventive intervention, EMOTION Coping Kids Managing Anxiety and Depression (EMOTION), to reduce high levels of anxiety and depressive symptoms.This is a clustered randomized controlled trial involving 36 schools, which are assigned to one of two conditions: (a) group cognitive behavioral intervention EMOTION or (b) treatment as usual (TAU). Assessments will be undertaken at pre-, mid - intervention, post-, and one year after intervention. The children (8-11 years old) complete self-report questionnaires. Parents and teachers report on children. The primary outcome will be changes in depressive and anxiety symptoms as measured by the Short Mood and Feelings Questionnaire (SMFQ) and Multidimensional Anxiety Scale for Children (MASC) respectively. Secondary outcomes will be changes in self-esteem, quality of life, and school and daily functioning. Observers will assess implementation quality with ratings of fidelity based on video recordings of group leaders leading the EMOTION group sessions.The present study is an important contribution to the field regarding working with children with symptoms of anxiety and depression. The results of this study will provide an indication whether or not the EMOTION program is an effective intervention for the prevention of later depression and/or anxiety in children. The study will also provide information about the EMOTION program's effect on quality of life, self-esteem, and school functioning of the children participating in the study. Finally, the project will provide insight into implementation of an indicated intervention for school-aged children within Norwegian health, education, and mental health services.Clinical Trials NCT02340637 , Registered on June 12, 2014, last updated on January 15, 2015. Retrospectively registered.

SUBMITTER: Patras J

PROVIDER: S-EPMC5037866 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression.

Patras Joshua J Martinsen Kristin Dagmar KD Holen Solveig S Sund Anne Mari AM Adolfsen Frode F Rasmussen Lene-Mari Potulski LP Neumer Simon-Peter SP

BMC psychology 20160926 1

<h4>Background</h4>High levels of anxiety and depression are common psychological symptoms among children and adolescents. These symptoms affect young people in multiple life domains and are possible precursors of long-term psychological distress. Despite relatively high prevalence, few children with emotional problems are referred for clinical treatment, indicating the need for systematic prevention. The primary aim of this study is to evaluate an indicated preventive intervention, EMOTION Copi ...[more]

PMID: 27671742

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Project description:BACKGROUND:Living with elevated symptoms of depression can have debilitating consequences for an individual's psychosocial and physical functioning, quality of life, and health care utilization. A growing body of evidence demonstrates that skills for increasing positive emotion can be helpful to individuals with depression. Although Web-based interventions to reduce negative emotion in individuals with depression are available, these interventions frequently suffer from poor retention and adherence and do not capitalize on the potential benefits of increasing positive emotion. OBJECTIVE:The aim of this study was to develop and test a Web-based positive emotion skills intervention tailored for individuals living with elevated depressive symptoms, as well as to develop and test enhancement strategies for increasing retention and adherence to that intervention. METHODS:This study protocol describes the development and testing for Mobile Affect Regulation Intervention with the Goal of Lowering Depression (MARIGOLD), a Web-based positive emotion skills intervention, adapted for individuals with elevated depressive symptomatology. The intervention development is taking place in three phases. In phase 1, we are tailoring an existing positive emotion skills intervention for individuals with elevated symptoms of depression and are pilot testing the tailored version of the intervention in a randomized controlled trial with two control conditions (N=60). In phase 2, we are developing and testing three enhancements aimed at boosting retention and adherence to the Web-based intervention (N=75): facilitator contact, an online discussion board, and virtual badges. In phase 3, we are conducting a multifactorial, nine-arm pilot trial (N=600) to systematically test these enhancement strategies, individually and in combination. The primary outcome is depressive symptom severity. Secondary outcomes include positive and negative emotion, psychological well-being, and coping resources. RESULTS:The project was funded in August 2014, and data collection was completed in May 2018. Data analysis is currently under way, and the first results are expected to be submitted for publication in 2018. CONCLUSIONS:Findings from this investigation will enable us to develop an optimal package of intervention content and enhancement strategies for individuals with elevated symptoms of depression. If this intervention proves to be effective, it will provide a cost-effective, anonymous, appealing, and flexible approach for reducing symptoms of depression and improving psychological adjustment through increasing positive emotion. TRIAL REGISTRATION:ClinicalTrials.gov NCT01964820 (Phase 1); https://clinicaltrials.gov/ct2/show/NCT01964820 (Archived by WebCite at http://www.webcitation.org/6zpmKBcyX). ClinicalTrials.gov NCT02861755 (Phase 2); https://clinicaltrials.gov/ct2/show/NCT02861755 (Archived by WebCite at http://www.webcitation.org/6zpmLmy8k). REGISTERED REPORT IDENTIFIER:RR1-10.2196/10494.

Project description:BACKGROUND:Depression and anxiety are common and co-morbid disorders that affect a significant proportion of students. Innovative prevention strategies targeting both conditions are needed to reduce their health burden and costs. ICare Prevent is such an innovative strategy and contains a transdiagnostic individually tailored Internet-based and mobile-supported intervention. It addresses common risk factors of depression and anxiety as part of a large EU-funded multi-country project* (ICare). Little is known about the clinical and cost-effectiveness of this type of intervention compared to care as usual (CAU) for college students. We hypothesize that ICare Prevent will be more (cost-)effective than CAU in the reduction of symptoms of depression and anxiety. METHODS:A three-arm, parallel, randomized controlled superiority trial will be conducted comparing a guided and an unguided version of ICare Prevent with a control group receiving CAU. The trial will be open-label but outcome assessors will be blinded. A total of 252 college students (age???16 years) with subclinical symptoms of depression defined as a score???16 on the Center for Epidemiological Studies Depression Scale (CES-D), and/or anxiety, defined as a score???5 on the Generalized Anxiety Disorder scale (GAD-7), will be included. Those meeting diagnostic criteria for a depressive or anxiety disorder will be excluded. The primary outcome is change in disorder specific symptom severity from baseline to post-intervention. Secondary endpoints include self-reported depression and anxiety symptoms as well as time to onset of a mood or anxiety disorder until 12-month follow-up. Societal costs and quality of life will be assessed to estimate the intervention's cost-effectiveness compared to CAU. DISCUSSION:Transdiagnostic individually tailored Internet-based prevention could be a (cost-)effective approach to tackle the disease burden of depression and anxiety among college students. TRIAL REGISTRATION:Dutch trial register, NTR 6562 . Registered on 6 July 2017.

Project description:BackgroundSiblings and parents of children with neurodevelopmental disorders are at risk of mental health problems and poorer family communication. Some group interventions for siblings exist, but few have clearly described parent components and none are considered evidence-based.MethodsWe are conducting a randomized controlled trial comparing a five-session manual-based group intervention for siblings (aged 8 to 16 years) and parents of children with neurodevelopmental disorders to a 12-week waitlist, called SIBS-RCT. The intervention comprises three separate sibling and parent group sessions and two joint sessions in which each sibling talks to their parent alone. The intervention aims at improving parent-child communication and covers themes such as siblings' understanding of the neurodevelopmental disorder, siblings' emotions, and perceived family challenges. Participants are recruited through municipal and specialist health centers across Norway. The primary outcome is sibling mental health. Quality of life and family communication are secondary outcomes. Participants are block-randomized to the intervention or 12-week waitlist in groups of six. Measures are collected electronically at pre- and post-intervention/waitlist, as well as 3, 6, and 12 months post-intervention. The main effect to be examined is the difference between the intervention and waitlist at 12 weeks post. All outcomes will also be examined using growth curve analyses. We plan to include 288 siblings and their parents by the end of 2022.DiscussionSIBS-RCT represents a major contribution to the research and practice field towards establishing an evidence-based intervention for siblings. In the event that intervention and waitlist are no different, the impact of SIBS-RCT is still substantial in that we will aim to identify participant subgroups that show positive response and effective components of the SIBS manual by examining group leader adherence as an outcome predictor. This will allow us to continue to re-engineer the SIBS manual iteratively to improve outcomes, and avoid the promotion of a less-than-optimal intervention.Trial registrationClinicalTrials.gov NCT04056884 . Registered in August 2019.

Project description:BackgroundTo reduce the large public health burden of the high prevalence of depression, preventive interventions targeted at people at risk are essential and can be cost-effective. Web-based interventions are able to provide this care, but there is no agreement on how to best develop these applications and often the technology is seen as a given. This seems to be one of the main reasons that web-based interventions do not reach their full potential. The current study describes the development of a web-based intervention for the indicated prevention of depression, employing the CeHRes (Center for eHealth Research and Disease Management) roadmap. The goals are to create a user-friendly application which fits the values of the stakeholders and to evaluate the process of development.MethodsThe employed methods are a literature scan and discussion in the contextual inquiry; interviews, rapid prototyping and a requirement session in the value specification stage; and user-based usability evaluation, expert-based usability inspection and a requirement session in the design stage.ResultsThe contextual inquiry indicated that there is a need for easily accessible interventions for the indicated prevention of depression and web-based interventions are seen as potentially meeting this need. The value specification stage yielded expected needs of potential participants, comments on the usefulness of the proposed features and comments on two proposed designs of the web-based intervention. The design stage yielded valuable comments on the system, content and service of the web-based intervention.ConclusionsOverall, we found that by developing the technology, we successfully (re)designed the system, content and service of the web-based intervention to match the values of stakeholders. This study has shown the importance of a structured development process of a web-based intervention for the indicated prevention of depression because: (1) it allows the development team to clarify the needs that have to be met for the intervention to be of use to the target audience; and (2) it yields feedback on the design of the application that is broader than color and buttons, but encompasses comments on the quality of the service that the application offers.

Project description:BACKGROUND:Digital mental health interventions offer a scalable solution that reduces barriers to seeking care for clinical depression and anxiety. OBJECTIVE:We aimed to examine the effectiveness of a 12-week therapist supported, app-based cognitive behavioral therapy program in improving symptoms of depression and anxiety within 9 months. METHODS:A total of 323 participants with mild to moderately severe depression or anxiety were enrolled in a 12-week digital cognitive behavior therapy program. The analysis was restricted to participants who provided at least one follow-up assessment after baseline. As a result, 146 participants (45.2%) were included in the analysis-74 (50.7%) participants completed assessments at 3 months, 31 participants (21.2%) completed assessments at 6 months, and 21 participants (14.4%) completed assessments at 9 months. The program included structured lessons and tools (ie, exercises and practices) as well as one-on-one weekly video counseling sessions with a licensed therapist for 12 weeks and monthly check-in sessions for 1 year. The clinically validated Patient Health Questionnaire (PHQ-8) and Generalized Anxiety Disorder Scale (GAD-7) were used to assess depression and anxiety, respectively. Linear mixed-effects modeling was employed to examine changes in depression and anxiety over time. RESULTS:We observed a significant positive effect of program time on improvement in depression (?=-0.12, P<.001) and anxiety scores (?=-0.10, P<.001). At the end of the 12-week intervention, we observed an average reduction of 3.76 points (95% CI -4.76 to -2.76) in PHQ-8 scores. Further reductions in depression were seen at program month 6 (4.75-point reduction, 95% CI -6.61 to -2.88) and program month 9 (6.42-point reduction, 95% CI -8.66 to -6.55, P<.001). A similar pattern of improvement emerged for anxiety, with a 3.17-point reduction at the end of the 12-week intervention (95% CI -4.21 to -2.13). These improvements were maintained at program month 6 (4.87-point reduction, 95% CI -6.85 to -2.87) and program month 9 (5.19-point, 95% -6.85 to 4.81). In addition, greater program engagement during the first 12 weeks predicted a greater reduction in depression (?=-0.29, P<.001). CONCLUSIONS:The results suggest that digital interventions can support sustained and clinically meaningful improvements in depression and anxiety. Furthermore, it appears that strong initial digital mental health intervention engagement may facilitate this effect. However, the study was limited by postintervention participant attrition as well as the retrospective observational study design.

Dataset Information

Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression.

Publications

Study protocol of an RCT of EMOTION: An indicated intervention for children with symptoms of anxiety and depression.

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