Anxiety DisordersNCT03916315
Transdiagnostic Treatment for Anxiety Disorders in Two Cities of México
A study testing Transdiagnostic Treatment in people with Anxiety Disorders, run by Universidad Autonoma de Baja California at 2 sites in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Transdiagnostic Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesMexico
- Study dates
- 4 Feb 2019to 6 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Symptoms of General Anxiety Disorder and/or Panic Disorder and/or Posttraumatic Stress Disorder and/or Social Anxiety Disorder and / or Obsessive Compulsive Disorder.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Mexico2 sites
Universidad Autonoma de Ciudad Juarez
Juárez, Chihuahua, 32300
Autonomous University of Baja California
Tijuana, Estado de Baja California, 22427
About this study
Official title: Effectiveness of the Transdiagnostic Treatment in the Population of Tijuana and Juarez With Anxiety and Electrophysiological Correlation Measurements. A Randomized Clinical Trial
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.
Read the 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:
- Post-Traumatic Stress Disorder (PTSD) Symptom Scale (PSS).
- Interview Program for Anxiety Disorders.
- Beck Depression Inventory.
- State Trait Anxiety Inventory.
- Generalized Anxiety Disorder 7-item (GAD-7) scale .
- Big Five Inventory.
- Scale of Beck's Suicidal Ideation.
- 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.
- Conditions
- Anxiety Disorders
- Being tested
- Transdiagnostic Treatment
- Keywords
- General Anxiety Disorder, Social Anxiety Disorder, Specific Phobia, Obsessive Compulsive Disorder, posttraumatic stress disorder
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder, Phobia, Social, Phobia, Specific, Obsessive-Compulsive Disorder, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdiagnostic TreatmentBehavioural
The Unified Transdiagnostic Protocol (PUT) is a cognitive-behavioral treatment focused on emotions. "The PUT was developed to be applicable to anxiety disorders, mood disorders, as well as other disorders in which anxiety and emotional dysregulation play an important role, such as many somatoform and dissociative disorders".
The PUT proposal includes 8 modules, of which 5 are nuclear, it is recommended to give these modules between 11 to 17 sessions with a duration of one hour each.
| Study group | Role | What they receive |
|---|---|---|
| Transdiagnostic Treatment | Experimental | Participants in this group will receive from 11 to 17 sessions of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Receives: Behavioral: Transdiagnostic Treatment |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Scale
The Post-Traumatic Stress Disorder Symptom Scale is a 17-item structured interview. The severity over the last 2 weeks of each item on the PSS is rated by the interviewer using a 4-point scale: 0 = not at all, 1 = a little bit, 2 = somewhat, and 3 = very much. The maximum possible score is 51 (severely affected) and the minimum possible score is 0 (total absence of the symptoms). The total severity score is calculated as the sum of the severity ratings for the 17 items. The diagnosis of the Post-Traumatic Stress Disorder Symptom Scale is made when at least 1 re-experiencing, 3 avoidance and 2 arousal symptoms are endorsed on the scale by individuals who were traumatized at least one month prior to the assessment. It is expected a statistical significant decrease (P < 0.05) in the symptoms of Post-Traumatic Stress Disorder in the patients suffering from this disorder.
Measured: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
Decrease in the score of Anxiety symptoms
The State Trait Anxiety Inventory consists of two subscales of 20 items each that measure anxiety as a transient state of tension (Scale A-State), and as a characteristic of the personality relatively stable over time (Scale B -trait). The items are composed by an assertion to which the subject responds indicating their degree of identification. In the case of state anxiety, the scale goes from 1 (not at all), 2 (somewhat), 3 (moderately), 4 (very much), while in the trait anxiety it ranges from 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). In both, a percentage of the items evaluates well-being or absence of anxiety, while the rest of the items to the presence of anxiety. Scores range from 20 to 80, in each subscale, with higher scores correlating with greater anxiety. It is expected a statistical significant decrease (P < 0.05) in the anxiety symptoms.
Measured: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
Decrease in the symptoms of depression
The Beck Depression Inventory is a self-report that provides a measure of the presence and severity of depression. Contains 21 items indicative of symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, suicidal thoughts or desires, pessimism, etc. Each item is answered on a 4-point scale, from 0 to 3, where each number is identified different for each item, in all of them 0 means absence and 3 full presence (e.g. sadness), except for items 16 (changes in the sleep pattern) and 18 (changes in appetite) that contain 7 categories. The minimum and maximum scores in the test are 0 and 63. Cut-off points ha that allow to classify those evaluated in one of the following four groups: 0-13, minimum depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression. It is expected a statistical significant decrease (P < 0.05) in the depression symptoms.
Measured: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
Decrease in the symptoms of General Anxiety Disorder
On the Generalized Anxiety Disorder 7-item (GAD-7) scale subjects are asked how often, during the last 2 weeks, they have been bothered by each of the 7 core symptoms of generalized anxiety disorder. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 representing mild, moderate, and severe anxiety symptom levels, respectively. It is expected a statistical significant decrease (P < 0.05) in the General Anxiety symptoms.
Measured: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
Decrease in gamma rhythm measures
Decrease in the gamma rhythm trough the EEG measure. The decrease will be shown comparing the participants in the intervention group within their own results in the pre to post measures, and comparing the participants in the control group vs. the intervention group.
Measured: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
Decrease is Obsessive Compulsive symptoms
The Yale-BrownObsessive Compulsive Scale (Y-BOCS) is composed of 10 items: 5 related to obsessions and the other 5, to compulsions, having an answer option from 0 to 4 (from not presenting a symptom until presenting extreme symptoms). The diagnostic classification is based on the points of cut where 0 to 7 represents "without clinical manifestations", 8 to 15, "mild", 16 to 23, "moderate", 24 to 31 as "severe" and 32 to 40 as "extreme". It is expected a statistical significant decrease (P < 0.05) in the Obsesive Compulsive symptoms.
Measured: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start4 Feb 2019
- Primary completion6 Jan 2020
- Study completion6 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Baja California
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de Ciudad Juarez
- Responsible party
- Principal investigator, Alejandro Dominguez Rodriguez, Universidad Autonoma de Baja California
- Investigators
- Alejandro Dominguez-Rodriguez, PhD, Study director, Autonomous University of Baja California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916315
- Sponsor's protocol ID
- F-PROMEP-38/Rev-04
- Status last verified
- Jul 2020
- First submitted
- 8 Apr 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study. The protocol of the study is currently in progress to be published, in this article will be included such study protocol, statistical analysis plan and the informed consent is already shared in the register of clinical trials.
Publications
Beck AT, Steer, RA, Brown, GK. Manual for Beck Depression Inventory-II. (1996) San Antonio, TX: Psychological Corporation.
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.
PubMed 3170753Brown 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.
PubMed 11261399Ellard 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.
PubMed 33762811Foa EB, Cashman L, Jaycox L, Perry K. The validation of a self-report measure of posttraumatic stress disorder: The posttraumatic diagnostic scale. Psychol Assess 1997;9(4):445-451.
Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.
PubMed 2684084John OP, Naumann LP, Soto CJ. Paradigm Shift to the Integrative Big-Five Trait Taxonomy: History, Measurement, and Conceptual Issues. In O. P. John, R. W. Robins, & L. A. Pervin (Eds.), Handbook of personality: Theory and research (pp. 114-158). 2008 New York, NY: Guilford Press.
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
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.
PubMed 18499328Spielberger C, Diaz-Guerrero R. IDARE: Inventario de Ansiedad Rasgo-Estado. México: Manual Moderno. 1975
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Yacila GA, Cook-del Aguila L, Sanchez-Castro AE, Reyes-Bossio M, Tejada RA. Traducción y adaptación cultural del Yale-Brown Obsessive Compulsive Scale (Y-BOCS) para trastornos obsesivos compulsivos Spanish translation and cultural adaptation of Yale- Brown Obsessive Compulsive Scale (Y-BOCS). Acta Médica Peruana. 2016. 33 (3):253-255.
Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
PubMed 18388841Hishinuma ES, Miyamoto RH, Nishimura ST, Nahulu LB, Andrade NN, Makini GK Jr, Yuen NY, Johnson RC, Kim SP, Goebert DA, Guerrero AP. Psychometric properties of the state-trait anxiety inventory for Asian/Pacific-islander adolescents. Assessment. 2000 Mar;7(1):17-36. doi: 10.1177/107319110000700102.
PubMed 10668003
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Transdiagnostic Treatment in the Population of Tijuana and Juarez With Anxiety and Electrophysiological Correlation Measurements. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03916315
- Acronym / sponsor ID
- F-PROMEP-38/Rev-04
- Conditions
- Anxiety Disorders
- Keywords
- General Anxiety Disorder, Social Anxiety Disorder, Specific Phobia, Obsessive Compulsive Disorder, posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Universidad Autonoma de Baja CaliforniaUniversity, hospital or other
- Collaborators
- Universidad Autonoma de Ciudad Juarez
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 6 Jan 2020 (actual)
- Study completion
- 6 Jan 2020 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Post-Traumatic Stress Disorder (PTSD) Symptom Scale (PSS).
- Interview Program for Anxiety Disorders.
- Beck Depression Inventory.
- State Trait Anxiety Inventory.
- Generalized Anxiety Disorder 7-item (GAD-7) scale .
- Big Five Inventory.
- Scale of Beck's Suicidal Ideation.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transdiagnostic Treatment | Experimental | Behavioral: Transdiagnostic TreatmentParticipants in this group will receive from 11 to 17 sessions of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Symptoms of General Anxiety Disorder and/or Panic Disorder and/or Posttraumatic Stress Disorder and/or Social Anxiety Disorder and / or Obsessive Compulsive Disorder.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdiagnostic TreatmentThe Unified Transdiagnostic Protocol (PUT) is a cognitive-behavioral treatment focused on emotions. "The PUT was developed to be applicable to anxiety disorders, mood disorders, as well as other disorders in which anxiety and emotional dysregulation play an important role, such as many somatoform and dissociative disorders". The PUT proposal includes 8 modules, of which 5 are nuclear, it is recommended to give these modules between 11 to 17 sessions with a duration of one hour each. | Behavioural | Transdiagnostic Treatment |
Primary outcome
Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Scale
Time frame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
The Post-Traumatic Stress Disorder Symptom Scale is a 17-item structured interview. The severity over the last 2 weeks of each item on the PSS is rated by the interviewer using a 4-point scale: 0 = not at all, 1 = a little bit, 2 = somewhat, and 3 = very much. The maximum possible score is 51 (severely affected) and the minimum possible score is 0 (total absence of the symptoms). The total severity score is calculated as the sum of the severity ratings for the 17 items. The diagnosis of the Post-Traumatic Stress Disorder Symptom Scale is made when at least 1 re-experiencing, 3 avoidance and 2 arousal symptoms are endorsed on the scale by individuals who were traumatized at least one month prior to the assessment. It is expected a statistical significant decrease (P < 0.05) in the symptoms of Post-Traumatic Stress Disorder in the patients suffering from this disorder.
Decrease in the score of Anxiety symptoms
Time frame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
The State Trait Anxiety Inventory consists of two subscales of 20 items each that measure anxiety as a transient state of tension (Scale A-State), and as a characteristic of the personality relatively stable over time (Scale B -trait). The items are composed by an assertion to which the subject responds indicating their degree of identification. In the case of state anxiety, the scale goes from 1 (not at all), 2 (somewhat), 3 (moderately), 4 (very much), while in the trait anxiety it ranges from 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). In both, a percentage of the items evaluates well-being or absence of anxiety, while the rest of the items to the presence of anxiety. Scores range from 20 to 80, in each subscale, with higher scores correlating with greater anxiety. It is expected a statistical significant decrease (P < 0.05) in the anxiety symptoms.
Decrease in the symptoms of depression
Time frame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
The Beck Depression Inventory is a self-report that provides a measure of the presence and severity of depression. Contains 21 items indicative of symptoms such as sadness, crying, loss of pleasure, feelings of failure and guilt, suicidal thoughts or desires, pessimism, etc. Each item is answered on a 4-point scale, from 0 to 3, where each number is identified different for each item, in all of them 0 means absence and 3 full presence (e.g. sadness), except for items 16 (changes in the sleep pattern) and 18 (changes in appetite) that contain 7 categories. The minimum and maximum scores in the test are 0 and 63. Cut-off points ha that allow to classify those evaluated in one of the following four groups: 0-13, minimum depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression. It is expected a statistical significant decrease (P < 0.05) in the depression symptoms.
Decrease in the symptoms of General Anxiety Disorder
Time frame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
On the Generalized Anxiety Disorder 7-item (GAD-7) scale subjects are asked how often, during the last 2 weeks, they have been bothered by each of the 7 core symptoms of generalized anxiety disorder. Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of ≥5, ≥10, and ≥15 representing mild, moderate, and severe anxiety symptom levels, respectively. It is expected a statistical significant decrease (P < 0.05) in the General Anxiety symptoms.
Decrease in gamma rhythm measures
Time frame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
Decrease in the gamma rhythm trough the EEG measure. The decrease will be shown comparing the participants in the intervention group within their own results in the pre to post measures, and comparing the participants in the control group vs. the intervention group.
Decrease is Obsessive Compulsive symptoms
Time frame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.
The Yale-BrownObsessive Compulsive Scale (Y-BOCS) is composed of 10 items: 5 related to obsessions and the other 5, to compulsions, having an answer option from 0 to 4 (from not presenting a symptom until presenting extreme symptoms). The diagnostic classification is based on the points of cut where 0 to 7 represents "without clinical manifestations", 8 to 15, "mild", 16 to 23, "moderate", 24 to 31 as "severe" and 32 to 40 as "extreme". It is expected a statistical significant decrease (P < 0.05) in the Obsesive Compulsive symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- BackgroundBeck AT, Steer, RA, Brown, GK. Manual for Beck Depression Inventory-II. (1996) San Antonio, TX: Psychological Corporation.
- Background: PubMed 3170753Beck 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.
- Background: PubMed 11261399Brown 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.
- Background: PubMed 33762811Ellard 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.
- BackgroundFoa EB, Cashman L, Jaycox L, Perry K. The validation of a self-report measure of posttraumatic stress disorder: The posttraumatic diagnostic scale. Psychol Assess 1997;9(4):445-451.
- Background: PubMed 2684084Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.
- BackgroundJohn OP, Naumann LP, Soto CJ. Paradigm Shift to the Integrative Big-Five Trait Taxonomy: History, Measurement, and Conceptual Issues. In O. P. John, R. W. Robins, & L. A. Pervin (Eds.), Handbook of personality: Theory and research (pp. 114-158). 2008 New York, NY: Guilford Press.
- BackgroundKennedy 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
- Background: PubMed 18499328Oathes 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.
- BackgroundSpielberger C, Diaz-Guerrero R. IDARE: Inventario de Ansiedad Rasgo-Estado. México: Manual Moderno. 1975
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- BackgroundYacila GA, Cook-del Aguila L, Sanchez-Castro AE, Reyes-Bossio M, Tejada RA. Traducción y adaptación cultural del Yale-Brown Obsessive Compulsive Scale (Y-BOCS) para trastornos obsesivos compulsivos Spanish translation and cultural adaptation of Yale- Brown Obsessive Compulsive Scale (Y-BOCS). Acta Médica Peruana. 2016. 33 (3):253-255.
- EMOTIV Epoc + 14 Channel Wireless EEG Headset. (2019, April).Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The information will be available in a private server or in a server of the journal(s) that we will publish the articles that will be the result of this study. The protocol of the study is currently in progress to be published, in this article will be included such study protocol, statistical analysis plan and the informed consent is already shared in the register of clinical trials.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Dominguez-Rodriguez, PhD study director
Autonomous University of Baja California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdiagnostic Treatment in people with Anxiety Disorders, run by Universidad Autonoma de Baja California at 2 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Scale (time frame: 3 to 4.5 months, depending on the development of the patient and the sessions needed, 11 to 17.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916315, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.