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Comprehensive technology-assisted training and supervision program to enhance depression management in primary care in Santiago, Chile: study protocol for a cluster randomized controlled trial.

ABSTRACT: Depression is a common and disabling condition. Since 2001, Chile has had a national program for depression in primary care and universal access to treatment for depressed people over the age of 15. There are National Guidelines to treat depression but no training program exists. The aim of the present study protocol is to measure the effectiveness of a comprehensive technology-assisted training and supervision program to enhance depression management in primary care.This is a two-arm, single-blind, cluster randomized controlled trial to compare the efficacy of the program versus usual care to treat depression in primary care clinics. In total, 434 depressed persons 18 to 65 years of age, recruited from four primary care clinics located in Santiago, will participate in the study.In order to ensure the quality of interventions supported by the national program for depression in Chile, it is desirable to have training programs of proven effectiveness.NCT02232854, registered on 2 September 2014.

SUBMITTER: Rojas G

PROVIDER: S-EPMC4512091 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Comprehensive technology-assisted training and supervision program to enhance depression management in primary care in Santiago, Chile: study protocol for a cluster randomized controlled trial.

Rojas Graciela G Martínez Pablo P Vöhringer Paul A PA Martínez Vania V Castro-Lara Ariel A Fritsch Rosemarie R

Trials 20150724

<h4>Background</h4>Depression is a common and disabling condition. Since 2001, Chile has had a national program for depression in primary care and universal access to treatment for depressed people over the age of 15. There are National Guidelines to treat depression but no training program exists. The aim of the present study protocol is to measure the effectiveness of a comprehensive technology-assisted training and supervision program to enhance depression management in primary care.<h4>Metho ...[more]

PMID: 26201546

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Project description:Introduction: Evidence from developed countries shows the efficacy of computer-assisted cognitive-behavioral therapy (cCBT) in addressing adolescent depression in home and/or school settings. This paper presents the results of a randomized controlled trial (RCT) of a brief therapist-guided cCBT intervention for adolescent depression in resource-constrained primary health care (PHC) settings. Material and methods: A multicenter, two-arm parallel-group, individually RCT with a 1:1 allocation ratio assigned 216 depressed adolescents (aged 15-19) attending four PHC centers in a low-income municipality of Santiago, Chile, to receive eight weekly face-to-face therapist-guided cCBT sessions by study therapists (N = 108), or to receive an enhanced usual care (EUC) intervention by trained PHC psychologists, encouraged to adhere to the national clinical guidelines for the management of depression (N = 108). Both groups received pharmacotherapy concordant with these guidelines. The primary outcome was the Beck Depression Inventory (BDI) at 4 months post-randomization, to assess depressive symptoms. BDI at 6 months post-randomization was a secondary outcome. Additional measures included patients' compliance, and satisfaction with different treatment components, at 6 months post-randomization. Main Results: The adjusted difference in mean BDI score between groups was -3.75 (95% CI -6.23 to -1.28; p = 0.003) at 4 months post-randomization. At 6 months post-randomization, the adjusted difference in mean BDI score between groups was -2.31 (95% CI -4.89 to 0.27; p = 0.078). The effect size was small-to-medium at 4 months post-randomization, d = 0.39 (0.12 to 0.67), and small and non-significant at 6 months post-randomization d = 0.29 (-0.00 to 0.59). Adolescents in the experimental treatment group were significantly more satisfied with treatment, with the PHC centers' facilities, with the psychological care received, and with non-professional staff than those in the comparator treatment group. Discussion: A brief therapist-guided cCBT eight-session intervention improves the response of depressed adolescents attending PHC centers at 4 months post-randomization. At 6 months post-randomization, the differences of between groups were not significant. Future research may focus on exploring strategies to sustain and increase response. Clinical trial registration: www.ClinicalTrials.gov, identifier NCT01862913 and URL: https://clinicaltrials.gov/ct2/show/NCT01862913.

Project description:BackgroundRates of perinatal depression in low and middle income countries are reported to be very high. Perinatal depression not only has profound impact on women's health, disability and functioning, it is associated with poor child health outcomes such as pre-term birth, under-nutrition and stunting, which ultimately have an adverse trans-generational impact. There is strong evidence in the medical literature that perinatal depression can be effectively managed with psychological treatments delivered by non-specialists. Our previous research in Pakistan led to the development of a successful perinatal depression intervention, the Thinking Healthy Program (THP). The THP is a psychological treatment delivered by community health workers. The burden of perinatal depression can be reduced through scale-up of this proven intervention; however, training of health workers at scale is a major barrier. To enhance access to such interventions there is a need to look at technological solutions to training and supervision.Methods/designThis is a non-inferiority, single-blinded randomized controlled trial. Eighty community health workers called Lady Health Workers (LHWs) working in a post-conflict rural area in Pakistan (Swat) will be recruited through the LHW program. LHWs will be randomly allocated to Technology-assisted Cascade Training and Supervision (TACTS) or to specialist-delivered training (40 in each group). The TACTS group will receive training in THP through LHW supervisors using a tablet-based training package, whereas the comparison group will receive training directly from mental health specialists. Our hypothesis is that both groups will achieve equal competence. Primary outcome measure will be competence of health workers at delivering THP using a modified ENhancing Assessment of Common Therapeutic factors (ENACT) rating scale immediately post training and after 3 months of supervision. Independent assessors will be blinded to the LHW allocation status.DiscussionWomen living in post-conflict areas are at higher risk of depression compared to the general population. Implementation of evidence-based interventions for depression in such situations is a challenge because health systems are weak and human resources are scarce. The key innovation to be tested in this trial is a Technology-assisted Cascade Training and Supervision system to assist scale-up of the THP.Trial registrationRegistered with ClinicalTrials.gov as GCC-THP-TACTS-2015, Identifier: NCT02644902 .

Dataset Information

Comprehensive technology-assisted training and supervision program to enhance depression management in primary care in Santiago, Chile: study protocol for a cluster randomized controlled trial.

Publications

Comprehensive technology-assisted training and supervision program to enhance depression management in primary care in Santiago, Chile: study protocol for a cluster randomized controlled trial.

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