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The Back2School modular cognitive behavioral intervention for youths with problematic school absenteeism: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:School absenteeism (SA) is associated with anxiety, depression, and disruptive behavior. It is a risk factor for academic difficulties and school dropout, which predict problems in adulthood such as social, work-related, and health problems. The main goal of this study is to examine the initial effectiveness of a modular transdiagnostic cognitive behavioral therapy (CBT) intervention (Back2School) for increasing school attendance and decreasing psychological problems, relative to a comparator control arm (treatment as usual [TAU]). METHODS/DESIGN:One hundred sixty children, aged 7 to 16?years, will be randomly assigned to either Back2School or TAU. The design is a two (Back2School and TAU) by four (preassessment [T1], postassessment [T2], and 3-month [T3] and 1-year [T4] assessments) mixed between-within design. The primary outcome is school attendance based on daily registration. Secondary outcomes pertain to youth psychosocial functioning, quality of life, bullying, self-efficacy, and teacher-parent collaboration. These secondary outcomes are measured via youth, parent, and teacher reports. DISCUSSION:This study will provide critically needed empirical evidence on the initial effectiveness of a manualized treatment program for youth with SA. If the intervention is found to be effective, the program can be further implemented and tested in a larger school health effectiveness trial. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03459677 . Retrospectively registered on 9 March 2018.

SUBMITTER: Thastum M

PROVIDER: S-EPMC6325742 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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The Back2School modular cognitive behavioral intervention for youths with problematic school absenteeism: study protocol for a randomized controlled trial.

Thastum Mikael M Johnsen Daniel Bach DB Silverman Wendy K WK Jeppesen Pia P Heyne David A DA Lomholt Johanne Jeppesen JJ

Trials 20190108 1

<h4>Background</h4>School absenteeism (SA) is associated with anxiety, depression, and disruptive behavior. It is a risk factor for academic difficulties and school dropout, which predict problems in adulthood such as social, work-related, and health problems. The main goal of this study is to examine the initial effectiveness of a modular transdiagnostic cognitive behavioral therapy (CBT) intervention (Back2School) for increasing school attendance and decreasing psychological problems, relative ...[more]

PMID: 30621787

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Project description:BackgroundAnxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. However, many anxious youth do not seek treatment. Low-intensity CBT in schools may improve access to evidence-based services. We aim to investigate the efficacy of two CBT youth anxiety programs with different intensities (i.e., number and length of sessions), both group-based and administered as early interventions in a school setting. The objectives of the study are to examine the effects of school-based interventions for youth anxiety and to determine whether a less intensive intervention is non-inferior to a more intensive intervention.Methods/designThe present study is a randomized controlled trial comparing two CBT interventions to a waitlist control group. A total of 18 schools participate and we aim to recruit 323 adolescents (12-16 years). Youth who score above a cutoff on an anxiety symptom scale will be included in the study. School nurses recruit participants and deliver the interventions, with mental health workers as co-therapists and/or supervisors. Primary outcomes are level of anxiety symptoms and anxiety-related functional impairments. Secondary outcomes are level of depressive symptoms, quality of life and general psychosocial functioning. Non-inferiority between the two active interventions will be declared if a difference of 1.4 or less is found on the anxiety symptom measure post-intervention and a difference of 0.8 on the interference scale. Effects will be analyzed by mixed effect models, applying an intention to treat procedure.DiscussionThe present study extends previous research by comparing two programs with different intensity. A brief intervention, if effective, could more easily be subject to large-scale implementation in school health services.Trial registrationClinicalTrials.gov, NCT02279251 . Registered on 15 October 2014. Retrospectively registered.

Project description:BACKGROUND:Perfectionism is elevated across, and increases risk for, a range of psychological disorders as well as having a direct negative effect on day-to-day function. A growing body of evidence shows that cognitive behavioral therapy (CBT) reduces perfectionism and psychological disorders, with medium to large effect sizes. Given the increased desire for Web-based interventions to facilitate access to evidence-based therapy, Internet-based CBT self-help interventions for perfectionism have been designed. Existing Web-based interventions have not included personalized guidance which has been shown to improve outcome rates. OBJECTIVE:To assess the efficacy of an Internet-based guided self-help CBT intervention for perfectionism at reducing symptoms of perfectionism and psychological disorders posttreatment and at 6-month follow-up. METHODS:A randomized controlled trial method is employed, comparing the treatment arm (Internet-based guided self-help CBT) with a waiting list control group. Outcomes are examined at 3 time points, T1 (baseline), T2 (postintervention at 12 weeks), T3 (follow-up at 24 weeks). Participants will be recruited through universities, online platforms, and social media and if eligible will be randomized using an automatic randomizer. RESULTS:Data will be analyzed to estimate the between group (intervention, control) effect on perfectionism, depression, and anxiety. Completer and intent-to-treat analyses will be conducted. Additional analysis will be conducted to investigate whether the number of modules completed is associated with change. Data collection should be finalized by December 2016, with submission of results for publication expected in mid-year 2017. Results will be reported in line with recommendations in the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH). CONCLUSIONS:Findings will contribute to the literature on treatment of perfectionism, the effect of treating perfectionism on depression and anxiety, and the efficacy of Internet-based guided self-help interventions. CLINICALTRIAL:ClinicalTrials.gov NCT02756871; https://clinicaltrials.gov/ct2/show/NCT02756871 (Archived by WebCite at http://www.webcitation.org/6lmIlSRAa).

Project description:BACKGROUND:Due to the progressive aging of the population, programs to promote active aging have been recommended. However, older adults have difficulty accessing them. Interventions administered through online video games may increase their accessibility, and complementing these with a smartphone app will likely increase adherence and allow for ongoing professional monitoring. The objective of this study is to evaluate the efficacy of a cognitive-behavioral intervention for active aging administered through an online interactive multimedia video game that includes a smartphone app companion. The secondary objectives are to analyze the moderators and mediators of the change in the outcome variables and to evaluate the adherence to the intervention. METHODS/DESIGN:A randomized controlled clinical trial will be conducted. Adults 45?years and older will be randomly assigned to a cognitive-behavioral intervention administered through an online multimedia video game that includes a smartphone app companion or to a control group that will receive online information on active aging (274 participants per group). The intervention will be administered in eight weekly 45-min modules. An investigator-blinded evaluation will be conducted using online self-administered tests at baseline, post-intervention, and 6- and 12-month follow-ups. The primary outcome will be mental health status as evaluated using the 36-item Short-Form Health Survey (SF-36) at post-intervention. Secondary outcomes will be emotional well-being, depressive symptoms, reinforcement, negative thoughts, self-reported memory, cognitive task performance, sleep hygiene behaviors, physical activity, eating habits, body mass index, social support, dropout, treatment adherence, and satisfaction with the intervention. DISCUSSION:If the results are favorable, this study would involve the development of the first evidence-based active aging promotion intervention based on a video game that includes a smartphone app companion, providing evidence on its efficacy, accessibility, and clinical utility. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03643237. Registered 27 August 2018.

Project description:BACKGROUND:Although major depression is a frequent disorder in non-professional caregivers and there are effective psychological interventions to prevent it, caregivers have difficulty accessing them. Interventions for depression applied through an app could improve accessibility; yet, to date, adherence to such interventions has been low. The objectives of this study are to (1) evaluate the efficacy of a cognitive behavioral depression prevention intervention administered through a smartphone app with and without telephone conference calls, (2) analyze the mediators of the change in the incidence of depression and depressive symptoms, and (3) assess adherence and satisfaction with the interventions. METHODS:A randomized controlled clinical trial will be conducted. Caregivers with elevated symptoms will be randomly assigned to a cognitive behavioral intervention administered by a smartphone app (CBIA) group, a CBIA plus telephone conference calls (TCCs) group (CBIA + TCC), or an attention control group. Each condition will consist of approximately 58 participants. Both interventions will be administered in five modules through a smartphone app and the CBIA + TCC group will receive additional TCCs in group format (four sessions of 30 min each). Trained blind assessors will conduct pre-treatment, post-treatment and follow-up assessments at 1, 3, 6, and 12 months. DISCUSSION:This study will provide evidence of the efficacy of a cognitive behavioral intervention to prevent depression in caregivers with elevated depressive symptoms administered through a smartphone app and the impact of feedback applied through conference calls to increase program adherence and efficacy. If the results were favorable, it would mean that we have developed a more effective, accessible, and clinically useful preventive depression intervention than the currently available ones for many present and future caregivers. TRIAL REGISTRATION:ClinicalTrials.gov: NCT03110991 . Registered 5 April 2017.

Project description:BackgroundPregnancy is strongly associated with increased risk for depression. Approximately 25% of pregnant women develop depression. Treatment for depression during pregnancy has several complexities: the use of psychiatric medications during pregnancy might result in developmental problems in the child and must be used with caution. Psychosocial interventions are effective, but they require specialized professionals. Low- and middle-income countries (LMIC) such as Brazil do not have enough mental health professionals needed to meet this demand. In this context, smartphone-based interventions show immense potential. We developed Motherly, a smartphone application (app) designed to treat maternal depression. We aim to test the efficacy of Motherly in addition to brief cognitive-behavioral therapies (CBT) to treat maternal depression.MethodsWe will conduct a 2-arm parallel-randomized controlled clinical trial in which 70 pregnant women aged between 16 and 40 years with depression will be randomized to intervention or active control. The intervention group will have access to Motherly, a smartphone app based on three concepts: psychoeducation, behavior monitoring, and gaming elements. Motherly is composed of a package of interventions composed of modules: mental health, sleep, nutrition, physical activity, social support, prenatal/postnatal support, and educational content. The main focus of Motherly is delivering behavioral activation (BA), a brief and structured psychological treatment. The app allows participants to schedule and engage in, and monitor activities according to a plan to avoid acting exclusively according to their mood. The active control group will have access to a simplified version of the app consisting of educational content about various aspects of pregnancy, maternal physical and mental health, and infant development (BA, activity scheduling, sleep hygiene, among other functionalities, will not be present in this version). Both groups will receive four sessions of brief CBT in 8 weeks. Participants will be evaluated by assessors blind to randomization and allocation status. Assessments will occur at baseline (T0), midpoint (T1, week 4-5), posttreatment (T2, week 8), and follow-up (T3, when the child is 2 months old). Maternal mental health (prenatal anxiety, psychological well-being, perceived stress, depression, depression severity, and sleep quality), quality of life, physical activity levels, and infant developmental milestones and social/emotional problems will be measured. Our primary outcome is the change in maternal prenatal depression from baseline to posttreatment (8 weeks).DiscussionThe potential of digital technology to deliver mental health interventions has been increasingly recognized worldwide. There is a growing literature on interventions using smartphone applications to promote mental health, both with or without the intermediation of a mental health professional. Our study adds to the literature by testing whether an app providing an intervention package, including CBT, psychoeducation, nutrition, physical activity, and social support, can promote maternal and child health and well-being. In particular, we aim to treat depression, for which the use of digital technologies is still scarce. Smartphone applications designed to treat maternal depression are especially relevant because of the potential to circumvent barriers that prevent pregnant women from accessing mental health care.Trial registrationClinicalTrials.gov NCT04495166 . Prospectively registered on July 29, 2020.

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The Back2School modular cognitive behavioral intervention for youths with problematic school absenteeism: study protocol for a randomized controlled trial.

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The Back2School modular cognitive behavioral intervention for youths with problematic school absenteeism: study protocol for a randomized controlled trial.

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