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Randomized Clinical Trial of a Primary Care Internet-based Intervention to Prevent Adolescent Depression: One-year Outcomes.

ABSTRACT: OBJECTIVE:We developed a primary care/Internet-based intervention for adolescents at risk for depression (CATCH-IT, Competent Adulthood Transition with Cognitive-behavioral, Humanistic and Interpersonal Training). This phase II clinical trial compares two forms of primary care provider (PCP) engagement (motivational interview [MI] and brief advice [BA]) for adolescents using the Internet program. METHOD:ADOLESCENTS SCREENING POSITIVE FOR DEPRESSION WERE RECRUITED FROM PRIMARY CARE PRACTICES AND RANDOMLY ASSIGNED TO A VERSION OF THE INTERVENTION: PCP MI + Internet program or PCP BA + Internet program. Between-group and within-group comparisons were conducted on depressive disorder outcome measures at baseline and one-year post-enrollment. Regression analyses examined factors predicting declines in depressed mood. RESULTS:Both groups demonstrated significant within-group decreases in depressed mood, loneliness, and self-harm ideation. While no between-group differences were noted in depressed mood or depressive disorder measures at one-year, fewer participants in the MI group had experienced a depressive episode. Greater participant automatic negative thoughts and more favorable ratings of a component of the Internet-based training experience predicted declines in depressed mood at one-year. CONCLUSIONS:A primary care/Internet-based intervention for depression prevention demonstrated sustained reductions in depressed mood, and, when coupled with motivational interviewing, reduction in the likelihood of being diagnosed with a depressive episode. This tool may help extend the services at the disposal of a primary care provider and can provide a bridge for adolescents at risk for depression prior to referral to mental health specialists.

SUBMITTER: Saulsberry A

PROVIDER: S-EPMC3647626 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

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Randomized Clinical Trial of a Primary Care Internet-based Intervention to Prevent Adolescent Depression: One-year Outcomes.

Saulsberry Alexandria A Marko-Holguin Monika M Blomeke Kelsey K Hinkle Clayton C Fogel Joshua J Gladstone Tracy T Bell Carl C Reinecke Mark M Corden Marya M Van Voorhees Benjamin W BW

Journal of the Canadian Academy of Child and Adolescent Psychiatry = Journal de l'Academie canadienne de psychiatrie de l'enfant et de l'adolescent 20130501 2

<h4>Objective</h4>We developed a primary care/Internet-based intervention for adolescents at risk for depression (CATCH-IT, Competent Adulthood Transition with Cognitive-behavioral, Humanistic and Interpersonal Training). This phase II clinical trial compares two forms of primary care provider (PCP) engagement (motivational interview [MI] and brief advice [BA]) for adolescents using the Internet program.<h4>Method</h4>ADOLESCENTS SCREENING POSITIVE FOR DEPRESSION WERE RECRUITED FROM PRIMARY CARE ...[more]

PMID: 23667356

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Project description:Depression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain.Our aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression.Multicenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken.There was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings.An Internet-based intervention for depression combined with iTAU conferred a benefit over iTAU alone in the Spanish primary health care system.Clinicaltrials.gov NCT01611818; https://register.clinicaltrials.gov/prs/app/action/SelectProtocol? selectaction=Edit&uid=U0001NPQ&ts=2&cx=gctdh2&sid=S0003KJ6 (Archived by WebCite at http://www.webcitation.org/6jbsUvUDz).

Project description:BackgroundThe high prevalence of major depressive disorder in adolescents and the low rate of successful treatment highlight a pressing need for accessible, affordable adolescent depression prevention programs. The Internet offers opportunities to provide adolescents with high quality, evidence-based programs without burdening or creating new care delivery systems. Internet-based interventions hold promise, but further research is needed to explore the efficacy of these approaches and ways of integrating emerging technologies for behavioral health into the primary care system.Methods/designWe developed a primary care Internet-based depression prevention intervention, Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training (CATCH-IT), to evaluate a self-guided, online approach to depression prevention and are conducting a randomized clinical trial comparing CATCH-IT to a general health education Internet intervention. This article documents the research framework and randomized clinical trial design used to evaluate CATCH-IT for adolescents, in order to inform future work in Internet-based adolescent prevention programs. The rationale for this trial is introduced, the current status of the study is reviewed, and potential implications and future directions are discussed.DiscussionThe current protocol represents the only current, systematic approach to connecting at-risk youth with self-directed depression prevention programs in a medical setting. This trial undertakes the complex public health task of identifying at-risk individuals through mass screening of the general primary care population, rather than solely relying on volunteers recruited over the Internet, and the trial design provides measures of both symptomatic and diagnostic clinical outcomes. At the present time, we have enrolled N = 234 adolescents/expected 400 and N = 186 parents/expected 400 in this trial, from N = 6 major health systems. The protocol described here provides a model for a new generation of interventions that blend substantial computer-based instruction with human contact to intervene to prevent mental disorders such as depression. Because of the potential for broad generalizability of this model, the results of this study are important, as they will help develop the guidelines for preventive interventions with youth at-risk for the development of depressive and other mental disorders.Trial registrationClinical trial registryNCT01893749 date 6 May 2012.

Project description:Although 13-20% of American adolescents experience a depressive episode annually, no scalable primary care model for adolescent depression prevention is currently available. To study whether CATCH-IT (Competent Adulthood Transition with Cognitive Behavioral Humanistic and Interpersonal Training) reduces the hazard for depression in at-risk adolescents identified in primary care, as compared to a general health education attention control (HE). The Promoting AdolescenT Health (PATH) study compares CATCH-IT and HE in a phase 3 single-blind multicenter randomized attention control trial. Participants were enrolled from 2012 to 2016 and assessed at 2, 6, 12, 18, and 24 months post-randomization. Primary care. Eligible adolescents were 13-18 years with subsyndromal depression and/or history of depression and no current depression diagnosis or treatment. Of 2,250 adolescents screened for eligibility, 446 participants completed the baseline interview and 369 were randomized into CATCH-IT (n=193) and HE (n=176). CATCH-IT is a 20-module (15 adolescent modules, 5 parent modules) online psychoeducation course that includes a parent program, supported by three motivational interviews. Time-to-event for depressive episode; depressive symptoms at 6 months. Mean age was 15.4 years, and 68% were female; 28% had both a past episode and subsyndromal depression; 12% had a past episode only, 59% had subsyndromal depression only, and 1% had borderline subsyndromal depression. The outcome of time-to-event favored CATCH-IT but was not significant with intention-to-treat analyses (N=369; unadjusted HR=0.59; 95% CI 0.27, 1.29; p=0.18; adjusted HR=0.53; 95% CI 0.23, 1.23, p=0.14). Adolescents with higher baseline CES-D10 scores showed a significantly stronger effect of CATCH-IT on time-to-event relative to those with lower baseline scores (p=0.04). For example, for a CES-D10 score of 15 (significant sub-syndromal depression), HR=0.20 (95% CI 0.05, 0.77), compared to CES-D10 of 5 (no sub-syndromal depression), HR=1.44 (95% CI, 0.41, 5.03). In both CATCH-IT and HE groups, depression symptoms declined and functional scores increased. CATCH-IT may be better than HE for preventing depressive episodes for at-risk adolescents with sub-syndromal depression. CATCH-IT may be a scalable approach to prevent depressive episodes in adolescents in primary care.

Project description:BackgroundDepression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care.MethodsCost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months.ResultsWith a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results.ConclusionsCompared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated.Trial registrationClinicalTrials.gov, NCT01151982. Registered on June 29, 2010.

Project description:Background: Depression is one of the most prevalent psychological disorders worldwide. Although psychotherapy for depression is effective, there are barriers to its implementation in primary care in Spain. The use of the Internet has been shown to be a feasible solution. However, the acceptability of Internet-based interventions has not been studied sufficiently. Objective: To assess the acceptability of an Internet-based intervention (IBI) for depression in primary care, and explore the relationship between expectations and satisfaction and the improvement in the clinical variables in primary care patients receiving this intervention. Furthermore, it offers data about the effects of some sociodemographic characteristics on these acceptability variables and analyzes whether the expectations are related to finalizing the intervention. Methods: Data were based on depressive patients who were participants in a randomized controlled trial. In the present study, we present the data from all the participants in the Internet intervention groups (N = 198). All the participants filled out the expectation and satisfaction scales (six-item scales regarding treatment logic, satisfaction, recommending, usefulness for other disorders, usefulness for the patient, and unpleasantness), the Beck Depression Inventory-II, and the secondary outcome measures: depression and anxiety impairment, and positive and negative affect. Results: Results showed that participants' expectations and satisfaction with the program were both high and differences in expectations and satisfaction depended on some sociodemographic variables (age: older people have higher expectations; sex: women have greater satisfaction). A positive relationship between these variables and intervention efficacy was found: expectations related to "usefulness for the patient" were a statistically related predictor to the results on the BDI-II (Beta = 0.364), and the perception of how logical the treatment is (Beta = 0.528) was associated with change in the clinical variable. Furthermore, the higher the expectations, the higher the improvements exhibited by the patients in all measures evaluated during the ten intervention modules. High expectations were also directly related to finalizing the intervention. Conclusions: This is the first study in Spain to address this issue in the field of IBIs for depression in primary care. The IBI showed high acceptance related to the intervention's efficacy and completion. Research on IBI acceptability could help to implement the treatment offered. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT01611818.

Dataset Information

Randomized Clinical Trial of a Primary Care Internet-based Intervention to Prevent Adolescent Depression: One-year Outcomes.

Publications

Randomized Clinical Trial of a Primary Care Internet-based Intervention to Prevent Adolescent Depression: One-year Outcomes.

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