Clinical trial NCT04642092: Evidence-Based Psychological Treatment for Emotional Disorders Attended in Dominican Primary Care Units (PsicAP)
Official title: Treatment for Emotional Disorders in Primary Care Units With Evidence-Based Psychological Techniques and mHealth: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety Disorders
Depression
Somatic Disorders
Emotional Disorder
Keywords: Cognitive Behavioral Therapy
Primary Care
Emotional Disorders
Lead sponsor: Pontificia Universidad Catolica Madre y Maestra
Sponsor class: OTHER
Collaborators: name: Ministerio de Educación Superior, Ciencia y Tecnología, Dominican Republic
First posted: 2020-11-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the score of Patient Health Questionnaire-2
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Patient Health Questionnaire-4
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Patient Health Questionnaire-9
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Patient Health Questionnaire-15
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Patient Health Questionnaire-PD
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Generalized Anxiety Disorder Test-2
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Generalized Anxiety Disorder Test-7
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Sheehan Disability Inventory
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of the Brooding subscale from Ruminative Responses Scale (RRS)
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of the Penn State Worry Questionnaire (PSWQ)
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Inventory of Cognitive Activity in Anxiety Disorders
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Questionnaire of Cognitive Distorsions in Emotional Disorders
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Emotion Regulation Questionnaire (ERQ)
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of Metacognitions Questionnaire (MCQ-30)
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of World Health Organization Quality of Life - BREF (WHOQOL-BREF)
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
measure: Change in the score of EuroQol-5 D (EQ-5D)
timeFrame: An average of 16 months (from baseline to psychological treatment completion).
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de los Caballeros
country: Dominican Republic
facility: Centro de Atención Primaria Dr. Sergio Bisonó (Barrio Lindo)
state: Santiago
city: Santiago de los Caballeros
country: Dominican Republic
facility: Centro de Atención Primaria El Guano
state: Santiago
city: Santiago de los Caballeros
country: Dominican Republic
facility: Centro de Atención Primaria Mamachen
state: Santiago
city: Santiago de los Caballeros
country: Dominican Republic
facility: Centro Diagnóstico Gurabo
state: Santiago
Study officials:
affiliation: Pontificia Universidad Catolica Madre y Maestra
name: Zoilo E García Batista, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pontificia Universidad Catolica Madre y Maestra
name: Kiero Guerra Peña, PhD
role: STUDY_CHAIR
affiliation: Universidad Complutense de Madrid
name: Antonio Cano-Vindel, PhD
role: STUDY_CHAIR
affiliation: King's College London
name: Ricardo Araya, PhD
role: STUDY_CHAIR
References:
citation: 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.