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A randomized efficacy trial of a cognitive-behavioral group intervention to prevent Internet Use Disorder onset in adolescents: The PROTECT study protocol.

ABSTRACT: Background:The reduction of prevalence rates of Internet Use Disorder (IUD) and its effective treatment are at high priority in both public health and educational policies. School-based preventive interventions facilitate a low-threshold approach for individuals with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated approaches which target adolescents at high-risk show larger effects than universal prevention programs. Simultaneously, they reduce unnecessary burden for the majority of high-school students that is not at-risk. The PROTECT group intervention for indicated prevention of IUD in school settings was developed based on these preventive strategies. Methods:Three-hundred and forty adolescents, aged 12-18 years, from 40 secondary schools in Germany, screened for high-risk of IUD onset, are randomly assigned to a) PROTECT preventive intervention group or b) assessment only control group. The tested intervention consists of a cognitive-behavioral 4-session brief-protocol. Follow-up assessments are at 1, 4 and 12 months after admission. Primary outcome is the 12-months incidence rate of IUD. Secondary outcomes are the reduction of IUD and comorbid symptoms as well as the promotion of problem solving, cognitive restructuring and emotion regulation skills. Conclusion:The indicated preventive intervention PROTECT follows the APA-guidelines for psychological prevention, i.e., it is theory- and evidence-based and addresses both risk-reduction and strength-promotion, it considers current research and epidemiology and ethical standards such as professional secrecy and is designed as a systemic intervention at the school-level. It is expected that the intervention decreases risk of IUD onset (incidence rate). Trial registration:ClinicalTrials.gov: NCT02907658.

SUBMITTER: Lindenberg K

PROVIDER: S-EPMC5936841 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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A randomized efficacy trial of a cognitive-behavioral group intervention to prevent Internet Use Disorder onset in adolescents: The PROTECT study protocol.

Lindenberg Katajun K Halasy Katharina K Schoenmaekers Sophie S

Contemporary clinical trials communications 20170329

<h4>Background</h4>The reduction of prevalence rates of Internet Use Disorder (IUD) and its effective treatment are at high priority in both public health and educational policies. School-based preventive interventions facilitate a low-threshold approach for individuals with IUD, who are typically characterized by high therapy avoidance. Moreover, indicated approaches which target adolescents at high-risk show larger effects than universal prevention programs. Simultaneously, they reduce unneces ...[more]

PMID: 29740637

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Project description:ImportanceBehavioral addictions were introduced as novel mental disorders in the International Classification of Diseases, 11th Revision, based on evidence that human behavior itself can become addictive, similar to addiction to substances. However, previous studies on prevention of gaming disorder and unspecified internet use disorder lacked randomization, follow-up measurements, and diagnostic interviews that assessed incidence rates; this trial was intended to fill this gap.ObjectivesTo investigate whether the PROTECT (Professioneller Umgang mit technischen Medien [Professional Use of Technical Media]) intervention can reduce the symptom severity and prevent full syndrome and subthreshold onset of gaming disorder and unspecified internet use disorder in at-risk adolescents.Design, setting, and participantsA multicenter cluster randomized clinical trial conducted recruitment, screening, intervention delivery, and data collection among at-risk adolescents aged 12 to 18 years in 33 high schools in Germany. Inclusion criteria for the study and symptom severity analyses were elevated symptoms of gaming disorder and unspecified internet use disorder. A subsample that met the inclusion criteria for incidence analyses (no full syndrome of gaming disorder or unspecified internet use disorder, depression, or anxiety at baseline) was analyzed for illness onset. Participants were randomized to either the PROTECT intervention group or the assessment-only control group. Participants were assessed at baseline, 1-month follow-up, 4-month follow-up, and 12-month follow-up between October 1, 2015, and September 30, 2018. Based on intent-to-treat principle, data analyses were conducted from February 8, 2019, to May 7, 2021.InterventionsPROTECT, a theory-driven, manualized, cognitive behavioral therapy-based indicated preventive group intervention that is delivered in 4 sessions by trained psychologists. It targets changes in addictive reward processing and pathological cognitive mechanisms.Main outcomes and measuresThe primary outcome was symptom severity (measured by CSAS [Computerspielabhängigkeitsskala], a modified German video game dependency scale with a score range of 0-56 [higher scores indicating greater pathology]) along with incidence rates (assessed by a structured clinical interview) after 12 months. Secondary outcomes were comorbid psychopathology and problem behaviors.ResultsA total of 422 at-risk adolescents (mean [SD] age, 15.11 [2.01] years; 229 female participants [54.3%]) were randomized to either the PROTECT intervention group (n = 167; mean [SD] risk score, 29.05 [6.98]) or the assessment-only control group (n = 255; mean [SD] risk score, 26.21 [5.01]) and were included in the symptom severity analyses. Compared with the control group, the PROTECT group showed a significantly greater reduction in symptom severity of gaming disorder or unspecified internet use disorder (γ11 = -0.128; 95% CI, -0.246 to -0.011; P = .03), reflecting a 39.8% vs 27.7% reduction of symptoms with an effect size of Cohen d = 0.67 (baseline vs 12-month follow-up) for the PROTECT group. Differences in incidence rates did not reach statistical significance. The PROTECT group showed a significantly greater decrease in procrastination (γ11 = -0.458; 95% CI, -0.735 to -0.180; P < .001) over 12 months, but no significant differences were found for other secondary outcomes.Conclusions and relevanceResults of this trial showed that the PROTECT intervention effectively reduced symptoms of gaming disorder and unspecified internet use disorder over 12 months. The intervention did not change incidence rates of gaming disorder or unspecified internet use disorder.Trial registrationClinicalTrials.gov Identifier: NCT02907658.

Project description:ImportanceTherapist-guided, internet-delivered cognitive behavioral therapy is an effective treatment option for children and adolescents with obsessive-compulsive disorder, but to our knowledge, its cost-effectiveness compared with traditional in-person treatment has not been established.ObjectiveTo evaluate the cost-effectiveness of guided internet-delivered cognitive behavioral therapy implemented within a stepped-care model compared with in-person cognitive behavioral therapy for young people with obsessive-compulsive disorder.Design, setting, and participantsThis economic evaluation of a randomized noninferiority trial conducted at 2 specialist obsessive-compulsive disorder clinics in Sweden enrolled 152 children and adolescents aged 8 to 17 years with obsessive-compulsive disorder, mainly through clinician referrals (110 [72%]). Recruitment began October 6, 2017, and ended May 24, 2019. Follow-up ended April 14, 2020.InterventionsParticipants were randomly assigned to receive either guided internet-delivered cognitive behavioral therapy or in-person cognitive behavioral therapy during a 16-week period. At the 3-month follow-up, nonresponders in both groups were offered additional in-person cognitive behavior therapy sessions.Main outcomes and measuresHealth outcomes were treatment response rates (primary outcome), remission rates, and quality-adjusted life-years. Cost data were collected before treatment, after treatment, at 3-month follow-up, and at 6-month follow-up (primary end point) and are presented in 2020 US dollars. The differences in incremental costs and health outcomes were compared between the groups and presented from the health care professional, health care sector, and societal perspectives.ResultsA total of 152 participants (94 girls [62%]; mean [SD] age, 13.4 [2.5] years) were randomized; 151 (99%) completed the trial. At the 6-month follow-up, 50 of 74 participants (68%) in the stepped-care group and 52 of 77 participants (68%) in the in-person cognitive behavioral therapy group were classified as treatment responders (odds ratio, 1.00 [95% CI, 0.51-1.98]; P = .99). Health economic analyses showed that the stepped-care group used fewer therapist resources than the in-person cognitive behavioral therapy group, resulting in a mean cost savings of $2104 (95% CI, $1202-$3006) per participant for the full study period of 10 months, corresponding to a relative savings of 39%. The cost savings remained largely comparable when taking wider health care sector and societal perspectives.Conclusions and relevanceThis study suggests that, for young people with obsessive-compulsive disorder, a low-cost digital intervention followed by in-person treatment for nonresponders was cost-effective compared with in-person cognitive behavior therapy alone.

Project description:ImportanceSocial anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong adversity and high costs for the individual and society at large. Cognitive behavioral therapy (CBT) is an established evidence-based treatment for SAD, but its availability is limited.ObjectiveTo assess the efficacy and cost-effectiveness of therapist-guided internet-delivered cognitive behavioral therapy (ICBT) for SAD in youths vs an active comparator, internet-delivered supportive therapy (ISUPPORT).Design, setting, and participantsThis single-masked, superiority randomized clinical trial enrolled participants at a clinical research unit integrated within the child and adolescent mental health services in Stockholm, Sweden, from September 1, 2017, to October 31, 2018. The final participant reached the 3-month follow-up (primary end point) in May 2019. Children and adolescents 10 to 17 years of age with a principal diagnosis of SAD and their parents were included in the study.InterventionsICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist.Main outcomes and measuresThe Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule, rated by masked assessors 3 months after the end of treatment. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor-rated diagnostic status of SAD and global functioning, child- and parent-reported social anxiety and depressive symptoms, and health-related costs.ResultsOf the 307 youths assessed for eligibility, 103 were randomized to 10 weeks of therapist-guided ICBT (n = 51) or therapist-guided ISUPPORT (n = 52) for SAD. The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Internet-delivered cognitive behavioral therapy was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. There was a significant between-group effect size of d = 0.67 (95% CI, 0.21-1.12) at the 3-month follow-up. Similarly, all of the secondary outcome measures demonstrated significant differences with small to large effect sizes, except for child-rated quality of life (nonsignificant). The cost-effectiveness analyses indicated cost savings associated with ICBT compared with ISUPPORT, with the main drivers of the savings being lower medication costs (z = 2.38, P = .02) and increased school productivity (z = 1.99, P = .047) in the ICBT group. There was 1 suicide attempt in the ISUPPORT group; no other serious adverse events occurred in either group.Conclusions and relevanceIn this randomized clinical trial, internet-delivered cognitive behavioral therapy was an efficacious and cost-effective intervention for children and adolescents with SAD. Implementation in clinical practice could markedly increase the availability of effective interventions for SAD.Trial registrationClinicalTrials.gov Identifier: NCT03247075.

Project description:Background: Informal caregivers are individuals who provide care for ill, frail, or otherwise dependent family members, siblings, or friends. Due to the caregiving demands, informal caregivers are known to experience negative mental health symptoms, such as stress or anxiety. Interventions based on Internet-based Cognitive Behavioral Therapy (ICBT) principles have been previously found to be effective for different populations and could also be considered as a plausible support option for informal caregivers. However, findings regarding effectiveness alone might not be sufficient for informing about the overall feasibility of the intervention. Objective: The aim of this process evaluation study was to evaluate the feasibility of a previously developed ICBT intervention for informal caregivers in Lithuania. More specifically, we evaluated the suitability of the intervention in relation to its content and delivery mode. Methods: Two studies were conducted. Study 1 consisted of participant evaluations of an 8-week, 8-module long therapist supported ICBT intervention. Evaluations for the Study 1 were retrieved from previously unused data, obtained from pilot testing of the intervention in which 63 informal caregivers took part. The evaluations contained of qualitative data (participant comments), as well as quantitative data (evaluations of each of the sessions). The Study 2 was an online stakeholder focus-group discussion conducted via Zoom. Eight stakeholders took part in the discussion, among whom there were social workers, medical professionals as well as individuals with caregiving experience themselves. Data were analyzed using descriptive statistics, thematic analysis, and data coding. Results: Results of the Study 1 showed that most of the pilot randomized controlled trial participants evaluated content and format of the intervention positively. These results were complemented by the findings in the Study 2, in which stakeholders evaluated the intervention as suitable and promising. In addition, stakeholders made certain suggestions for improving the intervention's usability for the informal caregivers. This included improving the instructions, providing with more guidance, and considering personalization options. Conclusion: The process evaluation helped to evaluate the feasibility of the ICBT intervention for informal caregivers in Lithuania from the two perspectives: users and stakeholders. Our findings suggest that the intervention is suitable for the target population.

Project description:Risky sexual behaviors of adolescents in Mexico are a public health problem; 33.4 % of adolescent girls and 14.7 % of boys report not having used any protection at their first intercourse. The fertility rate is 77 births/1000 girls aged 15-19 years. The infrequent contact of adolescents with health services and the limited extent of school sex and reproductive health education require the support of innovative strategies. The objective of this paper is to present the design of an internet-based educational strategy to prevent risky sexual behaviors in Mexican adolescents.A field trial with intervention and comparison group and with ex-ante and ex-post measurements will be conducted in two public secondary schools. Adolescents between 14 and 15 years of age will participate. The intervention will be conducted in one school and the second school will serve as a comparison group where the investigators will observe the usual sex education provided by the school. The intervention will be delivered using an internet web page that includes four educational sessions provided during a 4 week period. Follow-up will last 3 months. Information on the study variables will be obtained through an Internet-based self-applied questionnaire and collected on three occasions: 1) when the adolescents enter the study (baseline), 2) once the intervention is completed (at 1 month) and 3) after 3 months of follow-up (at the fourth month). There will be three outcome variables: 1) knowledge in regard to sexually transmitted infections, 2) attitudes regarding condom use, and 3) self-efficacy toward consistent condom use. The generalized linear model will be used to assess changes in each outcome variable controlling for baseline measures and for study covariates.The design and evaluation of an Internet-based educational strategy to prevent risky sexual behaviors in Mexican adolescents is important in order to provide a new, large-scale, easily implemented preventive tool.The study was registered at the ClinicalTrials.gov ID: NCT02686736 .

Project description:BackgroundAnxiety disorder is the most prevalent mental disorder among children and adolescents, causing significant psychosocial problems and physical health conditions. Cognitive behavioral therapy (CBT) is an effective treatment for anxiety disorder in children and adolescents. And parent-only CBT is an alternative treatment for childhood anxiety disorder, which includes psychologists and parents rather than children in the treatment. As a new type of CBT, parent-only CBT has some advantages. However, it remains unclear whether parent-only CBT interventions are effective for treating children and adolescents with anxiety disorder.MethodsIn this study, we evaluated the efficacy (the mean change scores of the anxiety rating scale from baseline to post-treatment, standardized mean difference SMD) and acceptability (the proportion of patients in the treatment group who withdrew from treatment early for any reason, risk ratios RRs) of parent-only cognitive behavioral therapy (CBT) for children and adolescents with anxiety disorder. We searched electronic databases, including PubMed, Cochrane Library, Embase, Web of Science, ProQuest, and PsycINFO from inception to June 2019. We included randomized controlled trials (RCTs) comparing parent-only CBT either with waitlist (WL), or CBT with parents in children and adolescents with anxiety disorder.ResultsFinally, six RCTs with 407 participants were included in the meta-analyses. In terms of efficacy, pooled analyses indicated that parent-only CBT was significantly more effective than WL for reducing anxiety symptoms with SMD of -?0.72 (95% CI -?1.41 to -?0.03, p = 0.04), and more remission rate with RR of 4.33 (37.96% vs. 6.85, 95% CI 1.82 to 10.27, p = 0.0009) at post-treatment. And our analyses showed no evidence that parent-only CBT had significantly greater efficacy than CBT with parents with SMD of 0.21 (95% CI -?0.09 to 0.50, p = 0.17). Acceptability in the parent-only CBT group was not significantly different to the WL group with RR of 0.92 (95% CI 0.52 to 1.62, p = 0.77), and was significantly worse than in the CBT with parents group with RR of 1.93 (95% CI 1.05 to 3.57, p = 0.03).ConclusionsCurrent evidence indicates that parent-only CBT can be an alternative and acceptable intervention for treating children and adolescents with anxiety disorder.

Dataset Information

A randomized efficacy trial of a cognitive-behavioral group intervention to prevent Internet Use Disorder onset in adolescents: The PROTECT study protocol.

Publications

A randomized efficacy trial of a cognitive-behavioral group intervention to prevent Internet Use Disorder onset in adolescents: The PROTECT study protocol.

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