Evidence-Based Psychological Treatment for Emotional Disorders Attended in Dominican Primary Care Units (PsicAP)

NCT ID: NCT04642092

Last Updated: 2021-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2023-05-31

Brief Summary

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Emotional disorders affect millions of people all over the world. Thousands of Dominicans suffer from depression, anxiety, and other emotional disorders that have negative impact on their lives. Nevertheless, many of them do not receive a proper treatment. The purpose of this study is to describe a pilot project, in which a protocol of evidence-based psychological treatment for emotional disorders, supported by mHealth (mobile health), will be applied on Dominicans who attend Primary Care services. It will be a collaborative program, divided into three phases, and based on cognitive behavioral therapy. The hypothesis of this research is that this protocol is an effective strategy to treat emotional disorders.

Detailed Description

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Emotional disorders, such as anxiety, depression and somatic disorders, represent a serious public health issue. Many people who suffer from them do not have access to an adequate psychological treatment. Some of the reasons why this situation happens are: the high cost that tends to represent a proper psychological treatment, and, in countries like Dominican Republic, the lack of a protocol that guides health professionals of Primary Care Units on the diagnosis and treatment of these emotional disorders. The purpose of this study is to describe a pilot project, in which a treatment protocol for emotional disorders will be applied by trained mental health professionals in Dominican Primary Care Units. It will be a randomized controlled trial with 300 patients. To prove the effectiveness of this protocol, the phases of this study will be: 1) psychological assessment of the study sample; 2) seven sessions of conventional treatment offered to a control group, and seven sessions of the evidence-based psychological techniques, suggested by this new protocol, given to an experimental group; 3) psychological reassessment of the study sample. This protocol suggests transdiagnostic approaches and collaborative interventions, that include group-sessions and evidence-based psychological techniques derived from cognitive behavioral therapy. Also, the protocol will be supported by mHealth tools. Some of the points included in the protocol are: psychoeducation on emotional disorders symptoms, relaxation and breathing techniques, thought management, improvement of quality of life and relapse prevention.

Conditions

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Anxiety Disorders Depression Somatic Disorders Emotional Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Participants and therapists will know if they are from the control or the experimental group. This study will be blinded only for the evaluators (the ones who will apply the psychological tests). Psychologists with the the role of evaluators will not give any therapy to the participants, and will not know from which group the patients are, neither who gave them the treatment.

Study Groups

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PsicAP protocol

The treatment of the experimental group will be according to the PsicAP protocol: seven sessions of a psychological treatment based on transdiagnostic approaches, collaborative interventions, group-sessions, and evidence-based psychological techniques derived from cognitive behavioral therapy.

Group Type EXPERIMENTAL

PsicAP protocol

Intervention Type BEHAVIORAL

The intervention will include: psychoeducation, relaxation and breathing techniques, thought management, tips to improve quality of life and relapse prevention. All of these activities will be based on scientific evidence and many of these aspects will be supported by mobile devices.

Conventional treatment

The control group will have seven sessions based on the typical psychological services that currently are offered in the Dominican Primary Care Units.

Group Type ACTIVE_COMPARATOR

Conventional treatment

Intervention Type BEHAVIORAL

Typical treatment that is currently given to patients with emotional disorders in Dominican primary care units.

Interventions

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PsicAP protocol

The intervention will include: psychoeducation, relaxation and breathing techniques, thought management, tips to improve quality of life and relapse prevention. All of these activities will be based on scientific evidence and many of these aspects will be supported by mobile devices.

Intervention Type BEHAVIORAL

Conventional treatment

Typical treatment that is currently given to patients with emotional disorders in Dominican primary care units.

Intervention Type BEHAVIORAL

Other Intervention Names

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Evidence-Based Psychological Techniques and mHealth

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 79 years old.
* Adults with mild or moderate levels of anxiety, depression or somatic disorders.
* Dominicans.
* People who are not receiving any psychological treatment.
* People who know how to read and write.

Exclusion Criteria

* A diagnostic of severe mental/emotional disorder.
* Recent suicide attempt.
* Severe disability.
* People who do not meet sufficient criteria to be diagnosed with mental or emotional disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministerio de Educación Superior, Ciencia y Tecnología, Dominican Republic

UNKNOWN

Sponsor Role collaborator

Pontificia Universidad Catolica Madre y Maestra

OTHER

Sponsor Role lead

Responsible Party

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Zoilo Emilio García Batista

PhD in Cognition, Emotion and Health; Director of the Vice-Rectory of Research and Innovation in PUCMM

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zoilo E García Batista, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica Madre y Maestra

Kiero Guerra Peña, PhD

Role: STUDY_CHAIR

Pontificia Universidad Catolica Madre y Maestra

Antonio Cano-Vindel, PhD

Role: STUDY_CHAIR

Universidad Complutense de Madrid

Ricardo Araya, PhD

Role: STUDY_CHAIR

King's College London

Locations

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Centro de Atención Primaria Dr. Sergio Bisonó (Barrio Lindo)

Santiago de los Caballeros, Santiago Province, Dominican Republic

Site Status RECRUITING

Centro de Atención Primaria El Guano

Santiago de los Caballeros, Santiago Province, Dominican Republic

Site Status RECRUITING

Centro de Atención Primaria Mamachen

Santiago de los Caballeros, Santiago Province, Dominican Republic

Site Status RECRUITING

Centro Diagnóstico Gurabo

Santiago de los Caballeros, Santiago Province, Dominican Republic

Site Status RECRUITING

Countries

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Dominican Republic

Central Contacts

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Zoilo E García Batista, PhD

Role: CONTACT

809 580 1962 ext. 4043

Kiero Guerra Peña, PhD

Role: CONTACT

809 580 1962 ext. 4526

Facility Contacts

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Cristhian A. García Díaz, MD

Role: primary

+18498893549

Claribel H. Ramírez Cabrera, Nurse

Role: backup

+18297944475

Altagracia Paulino González, MD

Role: primary

+18296821309

Lisbeth P Pérez Rodríguez, MD

Role: backup

+18297696842

Yolanda Y Castro Quezada, MD

Role: primary

+18299176751

Rosa E Cuello, MD

Role: backup

+18493548180

Juan G Durán, MD

Role: primary

+18295022024

Wanny W Roa Cabrera, MD

Role: backup

+18498584437

References

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Cano Vindel A. Bases teóricas y apoyo empírico de la intervención psicológica sobre los desórdenes emocionales en Atención Primaria. Una actualización. Ansiedad y estrés. 2011; 17(2-3): 157-184.

Reference Type BACKGROUND

Garcia-Batista ZE, Cantisano-Guzman LM, Guerra-Pena K, Alvarez A, Moretti L, Cano-Vindel A, Munoz-Navarro R, Medrano LA, Baltra RA. PsicAP transdiagnostic protocol of group cognitive-behavioral training for emotional disorders in Dominican Republic: a randomized controlled trial protocol. BMC Psychiatry. 2023 May 24;23(1):363. doi: 10.1186/s12888-023-04771-3.

Reference Type DERIVED
PMID: 37226144 (View on PubMed)

Other Identifiers

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2018-2019-2A1-96

Identifier Type: -

Identifier Source: org_study_id

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