Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anxiety Disorders
  • Depression
  • Emotional Disorder
  • Somatic Disorders
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Care Provider)Masking Description: 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.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 79 years
Gender
Both males and females

Description

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 pro...

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.

Tracking Information

NCT #
NCT04642092
Collaborators
Ministerio de Educación Superior, Ciencia y Tecnología, Dominican Republic
Investigators
Principal Investigator: Zoilo E García Batista, PhD Pontificia Universidad Catolica Madre y Maestra Study Chair: Kiero Guerra Peña, PhD Pontificia Universidad Catolica Madre y Maestra Study Chair: Antonio Cano-Vindel, PhD Universidad Complutense de Madrid Study Chair: Ricardo Araya, PhD King's College London