This study protocol aims to determine the efficacy of a collaborative multidimensional model (CMD) to improve the results of depression in primary care (PHC) in Chile. The CMD includes training of PHC teams, on the recognition of clinical, functional and psycho-biographic dimensions associated to a complex depression sub-type, difficult to treat, prevalent in PHC in Chile, for which there are no recommendations in current clinical guidelines. This model implies the implementation of a collaborative model, trauma informed care, patient- centered, that includes a case manager, the use of instruments and a close relationship between the PHC team and the specialty level. At least twelve primary care teams belonging to the Maule Region will be randomly assigned to one of the two arms of the study, the CMD group and the current standard model (SM). After the implementation of the CMD, an intentional sample of 394 participants who agreed to participate, with prior informed consent, will be evaluated by a blind research team at the beginning, at three and six months with a battery of instruments. An improvement in depressive symptoms, anxiety and functional variables is expected in participants treated in CMD versus SM. This protocol was approved by the Research Ethics Council of the University of Talca, Talca. The goal is to publish the preliminary results in December 2022.
The research design is a cluster randomized clinical trial. Inter-professional teams from at least 12 primary care centers of the Maule area will be randomized in two arms: intervention and control. The intervention arm will receive a training in the collaborative multidimensional model for depression (CMD) and the control arm will be trained in the current clinical guide (SM). After the CMD implementation, a sample of 394 participants entered to treatment for depression at their respective center will be invited to participate. This sample has been calculated estimating a maximum error of 5 %, a confidence level of 95 %, a power of 80 % a maximum variance of 50 % and a retention of 85 %. The patients who agreed to participate, will be treated by their respective PHC team and their therapeutic indications will be included in the official clinical records for each participant. Also these patients, after informed consent, will be evaluated by a blind external research team at the beginning, at three and six months with a battery of instrument. The informed consents will be kept in locked folders. The data obtained by the external evaluators will be confidential, entered into a virtual spreadsheet in a coded form on a server of the U. of Talca through a personal computer. Participant's diagnoses will be coded using the MINI. A protocol for the management of adverse situations of an emergency nature will be provided. The results will be presented according to the CONSORT guide for randomized clinical trials, with its extensions to cluster and non-pharmacological interventions. Analysis of the primary and secondary outcomes will be performed by intention to treat. In the initial analysis, the balance between the characteristics of the different samples will be evaluated and a linear multi-variable regression will be performed to establish differences at 3 and 6 months, adjusting the results according to the initial data, in case of imbalance for all outcomes. A sensitivity analysis based on different assumptions will also be implemented, to investigate the possible effects of missing data. Statistical analysis will be done with SPSS software. The research protocol was approved by the Ethics Committee of the University of Talca and approved by the Agencia Nacional de Investigación y Desarrollo (ANID), the national institution that audit the project through a follow-up sheet and yearly controls.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
394
The teams enrolled in the CMD intervention will have a 22-hour training that integrates current knowledge of depression with skills for the management of functional variables, interpersonal, social, emotional regulation, and history of biographical adversity from childhood considering the trauma informed care paradigm. After the training, the PHC teams will implement the depression treatment according to a collaborative model.
The teams enrolled in the SM intervention will have a 22-hour training that integrates the current national clinical guide for Depression in Chile. This guide offers a staggered treatment according to the severity of the depression. After the training, the PHC teams will implement the depression treatment according to the SM.
Change in Depressive symptoms at three months relative to baseline
Depressive symptoms will be assessed by the Patient Health Questionnaire (PhQ9). The Patient Health Questionnaire is a nine-item self-report measure that assesses the presence of depressive symptoms based on the DSM-IV criteria for major depressive. The Spanish version of the Patient Health Questionnaire has been validated in Chile. The Patient Health Questionnaire measures the symptoms experienced by the patients during the two weeks prior to the interview. Total score ranges from 0 to 27 points and greater scores means worse symptoms.
Time frame: Three months after admission to depression treatment
Change in Depressive symptoms at six months relative to baseline
Depressive symptoms will be assessed by the Patient Health Questionnaire (PhQ9). The Patient Health Questionnaire is a nine-item self-report measure that assesses the presence of depressive symptoms based on the DSM-IV criteria for major depressive. The Spanish version of the Patient Health Questionnaire has been validated in Chile. The Patient Health Questionnaire measures the symptoms experienced by the patients during the two weeks prior to the interview. Total score ranges from 0 to 27 points and greater scores means worse symptoms.
Time frame: Six months after admission to depression treatment
Change in Anxiety symptoms at three months relative to baseline
Anxiety symptoms will be evaluated by the generalized anxiety scale-7 (GAD/7 validated in Spanish). The generalized anxiety scale-7 serve as screening for generalized anxiety disorder. The generalized anxiety scale-7 is a 7 Likert-type items with response options from 0 to 3 points . A total score ranges from 0 to 21 points, greater scores means worse anxiety symptoms.
Time frame: Three months after admission to depression treatment
Change in Anxiety symptoms at six months relative to baseline
Anxiety symptoms will be evaluated by the generalized anxiety scale-7 (GAD/7 validated in Spanish). The generalized anxiety scale-7 serve as screening for generalized anxiety disorder. The generalized anxiety scale-7 is a 7 Likert-type items with response options from 0 to 3 points . A total score ranges from 0 to 21 points, greater scores means worse anxiety symptoms.
Time frame: Six months after admission to depression treatment
Change in Interpersonal Dysfunction and Social Dysfunction at three months relative to baseline
Interpersonal and social areas will be evaluated by the sub-scales of the Outcome Questionnaire (OQ-45) interpersonal and social role. The Outcome Questionnaire version 45-2 (OQ-45) is a self-administered instrument with evaluations in interpersonal and social role with Lkert-items whose response options range from 0 to 4 points. The interpersonal subscale includes 12 items with scores that range from 0 to 48 points and the social scale includes 9 items with scores that range from 0 to 36 points. Greater score means worse Interpersonal and social function.
Time frame: Three months after admission to depression treatment
Change in Interpersonal Dysfunction and Social Dysfunction at six months relative to baseline
Interpersonal and social areas will be evaluated by the sub-scales of the Outcome Questionnaire (OQ-45) interpersonal and social role. The Outcome Questionnaire version 45-2 (OQ-45) is a self-administered instrument with evaluations in interpersonal and social role with Likert-items whose response options range from 0 to 4 points. The interpersonal subscale includes 12 items with scores that range from 0 to 48 points and the social scale includes 9 items with scores that range from 0 to 36 points. Greater score means worse Interpersonal and social function.
Time frame: Six months after admission to depression treatment
Change in Emotion Regulation at three months relative to baseline
Difficulties in Emotion regulation will be evaluated by the Emotion Regulation Scale (ERS) validated in Chile. The Emotion Regulation Scale assesses emotions with respect to control, rejection, inattention, interference, and confusion. ERS scale consists of 28 items with a Likert-type response options from 1 to 5 points, the scores range from 0 to 140 points and greater scores indicate worse emotional regulation.
Time frame: Three months after admission to depression treatment
Change in Emotion Regulation at six months relative to baseline
Difficulties in Emotion regulation will be evaluated by the Emotion Regulation Scale (ERS) validated in Chile. The Emotion Regulation Scale assesses emotions with respect to control, rejection, inattention, interference, and confusion. ERS scale consists of 28 items with a Likert-type response options from 1 to 5 points, the scores range from 0 to 140 points and greater scores indicate worse emotional regulation.
Time frame: Six months after admission to depression treatment
Therapeutic adherence at three months
Adherence to treatment will be evaluated by the Scale of Adherence to General Health Treatment validated in Chile. The scale of Adherence consists of 21 questions with a Likert scale whose response options range from 1 to 6 points adding up to a total score from 22 to 132, lesser score means worst therapeutic adherence.
Time frame: Three months after admission to depression treatment
Therapeutic adherence at six months
Adherence to treatment will be evaluated by the Scale of Adherence to General Health Treatment validated in Chile. The Scale of Adherence consists of 21 questions with a Likert scale whose response options range from 1 to 6 points adding up to a total score from 22 to 132, lesser score means worst therapeutic adherence.
Time frame: Six months after admission to depression treatment
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