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Transdiagnostic Treatment for Anxiety Disorders in Two Cities of México

U

Universidad Autonoma de Baja California

Status

Completed

Conditions

Anxiety Disorders

Treatments

Behavioral: Transdiagnostic Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT03916315
F-PROMEP-38/Rev-04

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

74 participants in 2 patient groups

Transdiagnostic Treatment
Experimental group
Description:
Participants in this group will receive from 11 to 17 sessions of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders.
Treatment:
Behavioral: Transdiagnostic Treatment
Control group
No Intervention group
Description:
The participants in this group will not receive the treatment, just waiting list. They will be measured one time and then a second time 3 months after. Calculating when 3 months corresponding to 11-12 sessions will take place in the intervention group.

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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