Development and Validation of an Online Treatment Program for Adjustment Disorders
NCT ID: NCT02758418
Last Updated: 2018-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
68 participants
INTERVENTIONAL
2016-04-30
2019-07-31
Brief Summary
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It is expected that, on the one side, the intervention group will improve significantly compared to the waiting list control group. On the other side, it is expected the self-applied online treatment program to be well accepted and valued by the patient.
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Detailed Description
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A growing body of research has found that cCBT is highly effective for anxiety and depressive disorders, achieving clinical improvements similar to those obtained with traditional face-to-face interventions. The use of internet to administer EBT allows reducing the contact time between the patient and the therapist and this way reach people who otherwise would not receive treatment. Therefore, the development of a cCBT for AD will mean an improvement in the delivery and dissemination of the current treatment programs. This is especially relevant for this problem considering the scarce attention received by the scientific community and the high interference caused in the patients' life. As far as we know, there is no cCBT program specifically designed for the treatment of AD. As a consequence, further research in this area is needed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Online Computerized Program group.
Intervention group that uses "TAO" program.
TAO
"TAO" is a self-applied online treatment program and consists on the computerized version of the traditional CBT protocol for Adjustment Disorders.
The treatment protocol comprises different therapeutic components (see section Intervention) which are presented to the patients through 7 modules (one of them introductory). The Internet platform allows audiovisual resources (videos, illustrations, music and exercises that provide quick feedback) to be included, that makes the program more interactive.
Waiting list control group.
Participants of this group are able to access the treatment program after 7 weeks of waiting period. After this waiting period of 7 weeks, those participants still interested in receiving assistance are randomly assigned to one of two intervention conditions (Online Computerized Program group or Bibliotherapy group).
No interventions assigned to this group
Interventions
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TAO
"TAO" is a self-applied online treatment program and consists on the computerized version of the traditional CBT protocol for Adjustment Disorders.
The treatment protocol comprises different therapeutic components (see section Intervention) which are presented to the patients through 7 modules (one of them introductory). The Internet platform allows audiovisual resources (videos, illustrations, music and exercises that provide quick feedback) to be included, that makes the program more interactive.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meet DSM-V (APA, 2013) criteria for Adjustment Disorder.
* Be able to understand and read Spanish.
* Be able to use a computer and have an Internet connection at home.
* Have an e-mail address.
* If having any medication, not change the drug or the dose during the treatment period.
Exclusion Criteria
* Meet criteria for other severe mental disorder on Axis I: abuse or dependence of alcohol or other substances, psychotic disorder, dementia or bipolar disorder.
* Meet criteria for a severe personality disorder or illness.
* Presence of risk of suicide or self-destructive behaviors.
18 Years
65 Years
ALL
No
Sponsors
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Ministerio de Economía y Competitividad, Spain
OTHER_GOV
Universitat Jaume I
OTHER
Responsible Party
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Locations
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Universitat Jaume I
Castellon, , Spain
Countries
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References
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Baños RM, Guillén V, Quero S, García-Palacios A, Alcañiz M, Botella C. A virtual reality system for the treatment of stress-related disorders: A preliminary analysis of efficacy compared to a standard cognitive behavioral program. Int J Hum Comput Stud 69: 602-13, 2011.
Botella C, Baños RM, Guillén V. Una propuesta de tratamiento para los trastornos adaptativos: Creciendo en la adversidad. In: Vázquez C, Hervás G, eds. Psicología Positiva aplicada. Bilbao: Desclée de Brouwer; 2008: 129-154.
Quero S, Andreu-Mateu S, Baños RM, Guillén V, Molés M, Botella C. Eficacia de un protocolo de tratamiento apoyado con realidad virtual para el tratamiento de los trastornos adaptativos: Un estudio controlado. Paper presented at: I Congreso Nacional de Psicología Positiva; March, 2012; Madrid, Spain.
Quero S, Andreu-Mateu S, Moragrega I, Baños RM, Molés M, Nebot S, Botella C. Un programa cognitivo-conductual que utiliza la realidad virtual para el tratamiento de los trastornos adaptativos: Una serie de casos. Revista Argentina de Psicología Clínica. In press.
Quero S, Moles M, Perez-Ara MA, Botella C, Banos RM. An online emotional regulation system to deliver homework assignments for treating adjustment disorders. Stud Health Technol Inform. 2012;181:273-7.
Rachyla I, Quero S, Botella C. Un tratamiento auto-aplicado a través de Internet para los Trastornos Adaptativos: Descripción de un ensayo clínico controlado aleatorizado. Paper presented at: IX Congreso de la Asociación Española de Psicología Clínica y Psicopatología (AEPCP); October, 2015; Valencia, Spain.
Molés M. Eficacia diferencial de dos formas de aplicación de las tareas para casa en el tratamiento de los Trastornos Adaptativos: Aplicación apoyada por las TICs versus aplicación de forma tradicional [dissertation]. Castellón de la Plana, Spain: Universitat Jaume I; 2016.
Rachyla I, Perez-Ara M, Moles M, Campos D, Mira A, Botella C, Quero S. An internet-based intervention for adjustment disorder (TAO): study protocol for a randomized controlled trial. BMC Psychiatry. 2018 May 31;18(1):161. doi: 10.1186/s12888-018-1751-6.
Related Links
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Psychology and Technology web platform which will include TAO (Adjustment Disorders Online), an online computerized program for the treatment of Adjustment Disorders.
Laboratory of Psychology and Technology of the Universitat Jaume I.
Other Identifiers
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UJaumeI
Identifier Type: -
Identifier Source: org_study_id
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