NCT02758418

Brief Summary

The purpose of this study is to determine the efficacy and effectiveness of a self-help treatment for adjustment disorders administered through a computerized program applied over the Internet. This treatment modality will be compared with a waiting list control group. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

3.2 years

First QC Date

April 25, 2016

Last Update Submit

September 28, 2018

Conditions

Online Computerized Program GroupWaiting List Control Group

Keywords

Adjustment disorders onlinePsychological TreatmentsInformation and Communication TechnologiesInternet

Outcome Measures

Primary Outcomes (2)

  • Change in Beck Depression Inventory - Second Edition (BDI-II) (Beck, Steer, & Brown, 1996; validated in Spanish population by Sanz, Navarro, & Vázquez, 2003) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups.

    BDI-II is a self-report inventory that measures characteristic attitudes and symptoms of depression. The total score is obtained adding the 21 items which constitute the instrument and can be a maximum of 63 points. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and a test-retest reliability of around 0.8.

    Up to 12 months

  • Change in Beck Anxiety Inventory (BAI) (Beck & Steer, 1990; validated in Spanish population by Magán, Sanz, & García-Vera, 2008) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups.

    BAI measures the severity of both physiological and cognitive symptoms of anxiety. The 21 items are rated on a 4-point Likert-type scale (from 0 to 3) and the total score, which oscillates between 0 and 63, is obtained after directly adding the score of each item. Psychometric analysis carried out so far show excellent internal consistency (Cronbach's alpha ≥ 0.85).

    Up to 12 months

Secondary Outcomes (2)

  • Change in Inventory of Stress and Loss (Mor, Molés, Rachyla, & Quero, 2015) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups.

    Up to 12 months

  • Change in Posttraumatic Growth Inventory (PTGI) (Tedeschi & Calhoun, 1996) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups.

    Up to 12 months

Other Outcomes (4)

  • Change in Positive and Negative Affect Scale (PANAS) (Watson, Clark, & Tellegen, 1988) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups.

    Up to 12 months

  • Change in Environmental Reward Observation Scale (EROS) (Armento & Hopko, 2007; adapted and translated into Spanish by Barraca & Pérez-Álvarez, 2010) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups.

    Up to 12 months

  • Change in Multidimensional Quality of Life Questionnaire (MQLI) (Mezzich et al., 1999) score from pre-intervention to post-intervention and 3, 6 and 12 months follow-ups.

    Up to 12 months

  • +1 more other outcomes

Study Arms (2)

Online Computerized Program group.

EXPERIMENTAL

Intervention group that uses "TAO" program.

Other: TAO

Waiting list control group.

NO INTERVENTION

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).

Interventions

TAOOTHER

"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.

Also known as: TAO: Adjustment Disorders Online, Online Computerized CBT for Adjustment Disorders, Internet-based CBT for Adjustment Disorders
Online Computerized Program group.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be between 18 and 65 years of age.
  • 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.

You may not qualify if:

  • Be receiving other psychological treatment.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Jaume I

Castellon, 12006, Spain

Location

Related Publications (8)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 22954870BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 29855281DERIVED

Related Links

MeSH Terms

Interventions

Troleandomycin

Intervention Hierarchy (Ancestors)

OleandomycinMacrolidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 2, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

October 2, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)