Dataset Information

Internet-based stress recovery intervention for adolescents: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Research reveals a high prevalence of stressors in adolescence. Mental health in adolescence is highly related to life-stressors exposure and difficulties in adjusting to stressors. Therefore, interventions for recovery from stress are in high demand. The study aims to evaluate the efficacy of the Internet-based stress recovery intervention for adolescents.

Methods

A two-arm randomized controlled trial (RCT) on the efficacy of the FOREST-A-an Internet-based stress recovery intervention for adolescents-will be conducted. The FOREST-A is an adapted version of stress recovery intervention initially developed for healthcare workers. FOREST-A is a third-wave cognitive behavioral therapy and mindfulness-based Internet-delivered 4-week psychosocial intervention, which comprises six modules: Introduction, Relaxation, Psychological detachment, Mastery, Control, and Summary. The intervention will be evaluated using the two-arm RCT with intervention and care as usual (CAU) condition at pre-test, post-test, and 3-month follow-up. The measured outcomes will be stress recovery, adjustment disorder, generalized anxiety and depression symptoms, psychological well-being, and perceived positive social support.

Discussion

The study will contribute to the development of Internet interventions-easily and broadly accessible tools-for the enhancement of adolescents' stress recovery skills. Based on the study's findings, further development of the FOREST-A, including upscaling and implementation, is foreseen.

Trial registration

ClinicalTrials.gov NCT05688254. Registered on January 6, 2023.

SUBMITTER: Zelviene P

PROVIDER: S-EPMC9996863 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Internet-based stress recovery intervention for adolescents: study protocol for a randomized controlled trial.

Zelviene Paulina P Kairyte Agniete A Dumarkaite Austeja A Nomeikaite Augustė A Kazlauskas Evaldas E

Trials 20230308 1

<h4>Background</h4>Research reveals a high prevalence of stressors in adolescence. Mental health in adolescence is highly related to life-stressors exposure and difficulties in adjusting to stressors. Therefore, interventions for recovery from stress are in high demand. The study aims to evaluate the efficacy of the Internet-based stress recovery intervention for adolescents.<h4>Methods</h4>A two-arm randomized controlled trial (RCT) on the efficacy of the FOREST-A-an Internet-based stress recov ...[more]

PMID: 36890560

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Project description:Background: Mental disorders are highly prevalent among university students. Distance-learning students are particularly burdened and have limited access to conventional university health services. Interventions for stress are sought after in distance learners and may help increase treatment coverage. Internet-based interventions have been shown to be effective in preventing and treating depression, but it remains unclear if interventions directed at academic stress also have this potential. Aim: The trial presented here investigates the effectiveness of an Internet- and App-based stress intervention in distance-learning students with elevated levels of depression. Methods: A sample of N = 200 students of a large German distance university with elevated levels of depression [Center for Epidemiological Studies' Depression Scale (CES-D) ≥ 16] will be randomly assigned to either an Internet- and App-based stress management intervention group (IG) or a control group (CG) receiving an Internet-based psychoeducational program for academic stress. The IG consists of eight Internet-based sessions promoting stress management skills using cognitive-behavioral and problem-solving techniques. A mobile App will be employed to facilitate training transfer. Self-report data will be assessed at baseline (T0), post-treatment (T1; 7 weeks), and 3-month follow-up (T2). Potential moderators will be assessed at baseline. The primary outcome is depression (CES-D) post-treatment. Secondary outcomes include mental health outcomes, modifiable risk and protective factors, and academic outcomes. Data will be analyzed on an intention-to-treat principle along with sensitivity analyses to assess the robustness of findings. Additional health economic analyses will be conducted. Discussion: Results will provide the basis to assess the acceptance and effectiveness of Internet-delivered stress interventions in distance-learning students with symptoms of depression. Ethics and dissemination: The study has been reviewed and approved by the University of Erlangen-Nuremberg ethics committee (Erlangen, Germany; 33_17 Bc). Results of the study will be disseminated through peer-reviewed publications. Trial Registration: German Clinical Trial Registration (DRKS), identifier DRKS00011800.

Project description:BackgroundWork-related stress is widespread among employees and associated with high costs for German society. Internet-based stress management interventions (iSMIs) are effective in reducing such stress. However, evidence for their cost-effectiveness is scant.ObjectiveThe aim of this study was to assess the cost-effectiveness of a guided iSMI for employees.MethodsA sample of 264 employees with elevated symptoms of perceived stress (Perceived Stress Scale≥22) was assigned to either the iSMI or a waitlist control condition (WLC) with unrestricted access to treatment as usual. Participants were recruited in Germany in 2013 and followed through 2014, and data were analyzed in 2017. The iSMI consisted of 7 sessions plus 1 booster session. It was based on problem-solving therapy and emotion regulation techniques. Costs were measured from the societal perspective, including all direct and indirect medical costs. We performed a cost-effectiveness analysis and a cost-utility analysis relating costs to a symptom-free person and quality-adjusted life years (QALYs) gained, respectively. Sampling uncertainty was handled using nonparametric bootstrapping (N=5000).ResultsWhen the society is not willing to pay anything to get an additional symptom-free person (eg, willingness-to-pay [WTP]=€0), there was a 70% probability that the intervention is more cost-effective than WLC. This probability rose to 85% and 93% when the society is willing to pay €1000 and €2000, respectively, for achieving an additional symptom-free person. The cost-utility analysis yielded a 76% probability that the intervention is more cost-effective than WLC at a conservative WTP threshold of €20,000 (US $25,800) per QALY gained.ConclusionsOffering an iSMI to stressed employees has an acceptable likelihood of being cost-effective compared with WLC.Trial registrationGerman Clinical Trials Register DRKS00004749; https://www.drks.de/DRKS00004749.International registered report identifier (irrid)RR2-10.1186/1471-2458-13-655.

Project description:BackgroundThe COVID-19 pandemic demanded exceptional physical and mental effort from healthcare workers worldwide. Since healthcare workers often refrain from seeking professional psychological support, internet-delivered interventions could serve as a viable alternative option.ObjectiveWe aimed to investigate the effects of a therapist-guided six-week CBT-based internet-delivered stress recovery intervention among medical nurses using a randomized controlled trial design. We also aimed to assess program usability.Methods168 nurses working in a healthcare setting (Mage = 42.12, SDage = 11.38; 97 % female) were included in the study. The intervention group included 77 participants, and the waiting list control group had 91 participants. Self-report data were collected online at three timepoints: pre-test, post-test, and three-month follow-up. The primary outcome was stress recovery. Secondary outcomes included measures of perceived stress, anxiety and depression symptoms, psychological well-being, posttraumatic stress and complex posttraumatic stress symptoms, and moral injury.ResultsWe found that the stress recovery intervention FOREST improved stress recovery, including psychological detachment (d = 0.83 [0.52; 1.15]), relaxation (d = 0.93 [0.61, 1.25]), mastery (d = 0.64 [0.33; 0.95]), and control (d = 0.46 [0.15; 0.76]). The effects on psychological detachment, relaxation, and mastery remained stable at the three month follow-up. The intervention was also effective in reducing its users' stress (d = -0.49 [-0.80; -0.18]), anxiety symptoms (d = -0.31 [-0.62; -0.01]), depression symptoms (d = -0.49 [-0.80; -0.18]) and increasing psychological well-being (d = 0.53 [0.23; 0.84]) with the effects on perceived stress, depression symptoms, and well-being remaining stable at the three-month follow-up. High user satisfaction and good usability of the intervention were also reported.ConclusionsThe present study demonstrated that an internet-based intervention for healthcare staff could increase stress recovery skills, promote psychological well-being, and reduce stress, anxiety, and depression symptoms, with most of the effects being stable over three months.Trial registrationNCT04817995 (https://clinicaltrials.gov/ct2/show/NCT04817995). Registration date: March 30, 2021. Date of first recruitment: April 1, 2021.

Project description:BackgroundAnxiety disorders are among the most prevalent mental health concerns affecting children and adolescents. Despite their high prevalence, statistics indicate that fewer than 25% of individuals in this demographic seek professional assistance for their condition. Consequently, there is a pressing need to develop innovative interventions aimed at improving treatment accessibility.ObjectivesThis study aims to assess the effectiveness of Internet-delivered Cognitive Behavioral Therapy (iCBT) for adolescents with anxiety, with a specific emphasis on involving parents in the treatment process.MethodsThe study is structured as a parallel three-armed randomized controlled trial, comparing Internet-delivered Cognitive Behavioral Therapy (iCBT) with planned feedback, iCBT with on-demand feedback, and a waitlist control group, each group including 56 participants. Participants in the two iCBT conditions will undergo a 14-week treatment regimen, while those in the waitlist control group will wait for 14 weeks before starting iCBT with planned feedback. Additionally, participants in the iCBT groups will be randomly assigned to receive a booster session or not. The study design is factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). The study population comprises adolescents aged between 12 and 17 years, residing in Denmark, diagnosed with an anxiety disorder according to DSM-5 criteria. The primary outcome measures are the Youth Online Diagnostic Assessment and the Spence Children's Anxiety Scale. Assessments will occur at baseline, post-treatment, and at 3-, 6-, and 12-month follow-ups post-treatment.DiscussionThe findings of this study are anticipated to contribute to improving the accessibility of evidence-based treatments for adolescents with anxiety.Trial registrationThe study is registered at clinicalTrials.gov, under protocol ID 22/59602. The Initial release was the 16.10.2023, first posted due to technical problems 16.04.2024. https://clinicaltrials.gov/study/NCT06368557?locStr=Odense,%20Denmark&country=Denmark&city=Odense&page=2&rank=13 .

Project description:BackgroundResearch has shown that engaging in a range of healthy lifestyles or behavioral factors can help reduce the risk of developing dementia. Improved knowledge of modifiable risk factors for dementia may help engage people to reduce their risk, with beneficial impacts on individual and public health. Moreover, many guidelines emphasize the importance of providing education and web-based resources for dementia prevention. Internet-based interventions may be effective, but few have been studied rigorously or widely disseminated. We created DementiaRisk, an award-winning, web- and email-based education platform for the public focused on modifiable risk factors, featuring multimedia e-learning and email "microlearning" content, to help raise awareness and improve knowledge of actions to reduce dementia risk.ObjectiveThis protocol describes a randomized controlled trial to (1) evaluate whether exposure to DementiaRisk changes knowledge of dementia risk factors, intention to engage in risk reduction activities, and health behaviors related to dementia risk reduction and to (2) explore qualitative aspects including participants' engagement and satisfaction with the intervention and barriers and facilitators to use.MethodsUsing a sequential explanatory mixed methods design, this study conducts a quantitative analysis followed by a qualitative inquiry to evaluate outcomes and feasibility. In total, 485 participants will be recruited on the web and randomly assigned to 2 groups: one accessing DementiaRisk and the other receiving alternative e-learning on mild cognitive impairment. Assessments will be delivered on the web at baseline (T1), at 4 weeks (T2), and at 2 months after the intervention (T3). Knowledge will be assessed using items from the Dementia Knowledge Assessment Scale, intentions to engage in risk reduction activities will be assessed using items in line with current evidence, and health behaviors related to dementia risk reduction will be assessed using items from the Godin-Shephard Leisure Time Physical Activity Questionnaire along with additional questions related to a range of health status domains. Outcomes and feasibility will be assessed using the Information Assessment Method for patients and consumers. A linear mixed effects model will be used to examine the relationship between each outcome score by group and time point.ResultsThis study was approved by the Hamilton Integrated Research Ethics Board on August 24, 2022 (project ID 14886) and received funding in February 2023. Recruitment took place from March 28, 2023, to April 28, 2023, with the final participants completing the intervention by August 18, 2023. Analyses and interpretation of data are ongoing.ConclusionsDementiaRisk is a readily scalable, technology-enhanced solution for dementia prevention education. It has been designed using evidence-based principles of multimedia learning. It has the potential to scale and spread widely using the open internet, so it may be able to reach a wider audience than traditional in-person educational interventions.Trial registrationClinicalTrials.gov NCT05383118; https://clinicaltrials.gov/study/NCT05383118.International registered report identifier (irrid)DERR1-10.2196/64718.

Project description:BACKGROUND:Adjustment Disorder (AjD) is a common and disabling mental health problem. The lack of research on this disorder has led to the absence of evidence-based interventions for its treatment. Moreover, because the available data indicate that a high percentage of people with mental illness are not treated, it is necessary to develop new ways to provide psychological assistance. The present study describes a Randomized Controlled Trial (RCT) aimed at assessing the effectiveness and acceptance of a linear internet-delivered cognitive-behavioral therapy (ICBT) intervention for AjD. METHODS:A two-armed RCT was designed to compare an intervention group to a waiting list control group. Participants from the intervention group will receive TAO, an internet-based program for AjD composed of seven modules. TAO combines CBT and Positive Psychology strategies in order to provide patients with complete support, reducing their clinical symptoms and enhancing their capacity to overcome everyday adversity. Participants will also receive short weekly telephone support. Participants in the control group will be assessed before and after a seven-week waiting period, and then they will be offered the same intervention. Participants will be randomly assigned to one of the 2 groups. Measurements will be taken at five different moments: baseline, post-intervention, and three follow-up periods (3-, 6- and 12-month). BDI-II and BAI will be used as primary outcome measures. Secondary outcomes will be symptoms of AjD, posttraumatic growth, positive and negative affect, and quality of life. DISCUSSION:The development of ICBT programs like TAO responds to a need for evidence-based interventions that can reach most of the people who need them, reducing the burden and cost of mental disorders. More specifically, TAO targets AjD and will entail a step forward in the treatment of this prevalent but under-researched disorder. Finally, it should be noted that this is the first RCT focusing on an internet-based intervention for AjD in the Spanish population. TRIAL REGISTRATION:ClinicalTrial.gov: NCT02758418 . Trial registration date 2 May 2016.

Dataset Information

Internet-based stress recovery intervention for adolescents: study protocol for a randomized controlled trial.

Background

Methods

Discussion

Trial registration

Publications

Internet-based stress recovery intervention for adolescents: study protocol for a randomized controlled trial.

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