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

Pontificia Universidad Catolica Madre y Maestra

Status: Unknown

Conditions: Emotional Disorder; Somatic Disorders; Depression; Anxiety Disorders

Treatments: Behavioral: Conventional treatment; Behavioral: PsicAP protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04642092

2018-2019-2A1-96

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

PsicAP protocol

Experimental group

Description:

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.

Treatment:

Behavioral: PsicAP protocol

Conventional treatment

Active Comparator group

Description:

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

Treatment:

Behavioral: Conventional treatment