NCT04642092

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

Treatment for Emotional Disorders in Primary Care Units With Evidence-Based Psychological Techniques and mHealth: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Pontificia Universidad Catolica Madre y Maestra · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Anxiety Disorders
• Depression
• Somatic Disorders
• Emotional Disorder

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Conventional treatment	Typical treatment that is currently given to patients with emotional disorders in Dominican primary care units.

Timeline

• Start date: 2021-08-09
• Primary completion: 2023-05-01
• Completion: 2023-05-01
• First posted: 2020-11-24
• Last updated: 2021-10-07

Locations

4 sites across 1 country: Dominican Republic