Clinical trial NCT03916315: Transdiagnostic Treatment for Anxiety Disorders in Two Cities of México
Official title: Effectiveness of the Transdiagnostic Treatment in the Population of Tijuana and Juarez With Anxiety and Electrophysiological Correlation Measurements. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: General Anxiety Disorder
Social Anxiety Disorder
Specific Phobia
Obsessive Compulsive Disorder
posttraumatic stress disorder
Lead sponsor: Universidad Autonoma de Baja California
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Ciudad Juarez
First posted: 2019-04-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study has two arms, one is the intervention group that receive the treatment and the other is the control group that does not receive treatment, just waiting list, however at the end of the assesment the participants in the control group will also receive the treatment. The patients in both groups will be evaluated pre and post treatment. 11 sessions, once per week, therefore 3 months apart.
Primary purpose: TREATMENT

Brief summary: This study evaluates the effectiveness of The Unified Transdiagnostic Protocol, a psychological treatment for the intervention of a broad range of anxiety disorders. It is compared the effectiveness of the treatment with the changes of the same participants before and after the treatment and a control group. The changes are being assessed through subjective measures such as psychometrics and objective measures such as Electroencelophalography.

Detailed description: Anxiety disorders are among the highest prevalence of disorders in the general population worldwide, however, in the last decades they were treated by separate.

However, it has been proposed that several emotional disorders have a common root and can be treated similarly. This is called the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. The treatment has as objective to be implemented from 11 to 17 sessions, with 8 modules. This treatment can be applied to a bigger range of disorders, not only anxiety disorder, however, the objective of this study is to focus on the most urgent disorders in the border of Mexico and USA, that are anxiety disorders. According to the available scientific literature, this is the first time that this study has been applied in Mexican population. This study will have an intervention group that will receive the transdiagnostic treatment, and a control group that will be in a waiting list, and after the waiting list and the measured took place these patients will also receive the treatment. In both conditions the participants will be measured pre and post. The subjective measures will include the following psychometrics:

1. Post-Traumatic Stress Disorder (PTSD) Symptom Scale (PSS).
2. Interview Program for Anxiety Disorders.
3. Beck Depression Inventory.
4. State Trait Anxiety Inventory.
5. Generalized Anxiety Disorder 7-item (GAD-7) scale .
6. Big Five Inventory.
7. Scale of Beck's Suicidal Ideation.
8. Yale-BrownObsessive Compulsive Scale (Y-BOCS)

Also it is planned to measure the brain activity through an electroencephalogram, specifically the Gamma rhythm. It has been observed that when patients with General Anxiety disorder are emotionally aroused their Gamma rhythm increases. Part of the objectives of this study is to replicate the procedure by Oathes et al., that consist in measuring the brain activity of the participants with an electroencephalogram of 17 channels, following these steps: 2 minutes' base line, 5 minute relaxation and 5 minutes emotionally aroused, in their study it was observed in the patients that the Gamma rhythm was lower in the relaxation phase, increasing at the base line and having the highest record in the emotionally aroused minutes. To perform this measure, it will be used the EMOTIVE EPOC + of 14 channels is non-invasive, painless, low cost method Used for scientific research. The 14 channels with which the device counts. It allows to measure the cerebral areas AF3, F7, F3, FC5, T7, P7, O1, O2, P8, T8, FC6, F4, F8, AF4, based on the international system 10-20.

Eligibility criteria: Inclusion Criteria:

* Symptoms of General Anxiety Disorder and/or Panic Disorder and/or Posttraumatic Stress Disorder and/or Social Anxiety Disorder and / or Obsessive Compulsive Disorder.

Exclusion Criteria:

* Consuming drugs
* To receive another psychological treatment in the same period of the study
* To be consuming medicines to treat symptoms of anxiety or depression
* To show comorbidity with a psychiatric disorder
* Moderate to high score in the suicide scale
* Recent attempt of suicide (3 months) measured with the Scale of Beck's Suicidal Ideation (Beck, Steer and Ranieri, 1988).

Primary outcomes:
measure: Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Scale
timeFrame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
measure: Decrease in the score of Anxiety symptoms
timeFrame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
measure: Decrease in the symptoms of depression
timeFrame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
measure: Decrease in the symptoms of General Anxiety Disorder
timeFrame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
measure: Decrease in gamma rhythm measures
timeFrame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
measure: Decrease is Obsessive Compulsive symptoms
timeFrame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
Secondary outcomes:
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Autonomous University of Baja California
state: Baja California
city: Juarez
country: Mexico
facility: Universidad Autonoma de Ciudad Juarez
state: Chihuahua
Study officials:
affiliation: Autonomous University of Baja California
name: Alejandro Dominguez-Rodriguez, PhD
role: STUDY_DIRECTOR
References:
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citation: Beck AT, Steer RA, Ranieri WF. Scale for Suicide Ideation: psychometric properties of a self-report version. J Clin Psychol. 1988 Jul;44(4):499-505. doi: 10.1002/1097-4679(198807)44:43.0.co;2-6.
citation: Brown TA, Di Nardo PA, Lehman CL, Campbell LA. Reliability of DSM-IV anxiety and mood disorders: implications for the classification of emotional disorders. J Abnorm Psychol. 2001 Feb;110(1):49-58. doi: 10.1037//0021-843x.110.1.49.
citation: Ellard KK, Fairholme CP, Boisseau CL, Farchione TJ, Barlow DH. Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders: Protocol Development and Initial Outcome Data. Cogn Behav Pract. 2010 Feb;17(1):88-101. doi: 10.1016/j.cbpra.2009.06.002. Epub 2010 Jan 29.
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citation: Kennedy KA, Barlow DH. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: An introduction. In Farchione TJ, Barlow, DH (Eds.), Applications of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. New York: Oxford University Press. 2017
citation: Oathes DJ, Ray WJ, Yamasaki AS, Borkovec TD, Castonguay LG, Newman MG, Nitschke J. Worry, generalized anxiety disorder, and emotion: evidence from the EEG gamma band. Biol Psychol. 2008 Oct;79(2):165-70. doi: 10.1016/j.biopsycho.2008.04.005. Epub 2008 Apr 15.
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