Online Computerized Program GroupTAONCT02758418
Development and Validation of an Online Treatment Program for Adjustment Disorders
A study testing TAO in people with Online Computerized Program Group and Waiting List Control Group, run by Universitat Jaume I at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Online Computerized Program Group, Waiting List Control Group
- What is being tested?
- TAO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Jul 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Internet-based CBT Program for Adjustment Disorders: A Randomized Controlled Trial
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.
Read the detailed description
Adjustment Disorder (AD) is a highly prevalent health problem that causes a great suffering and can result in suicidal thinking and/or behavior. However, unlike mood and anxiety disorders, AD has received little attention from scientific community and very few studies have been carried out to develop evidence-based treatments (EBT) for this problem. Besides, although a cognitive behavioral therapy (CBT) protocol is currently available for the treatment of AD, many patients with this diagnosis remain untreated. There is therefore an evident need to design strategies that guarantee the patients receive adequate treatment. A feasible solution might be self-administered computerized CBT (cCBT).
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.
- Being tested
- TAO
- Keywords
- Adjustment disorders online, Psychological Treatments, Information and Communication Technologies, Internet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAOOther
Also called TAO: Adjustment Disorders Online, Online Computerized CBT for Adjustment Disorders, Internet-based CBT for Adjustment Disorders
"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.
| Study group | Role | What they receive |
|---|---|---|
| Online Computerized Program group. | Experimental | Intervention group that uses "TAO" program. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
This inventory is an adaptation of the Complicated Grief Inventory (CGI; Prigerson et al., 1995). It consists of 17 first-person statements regarding the degree to which the lost person/situation interferes in the individual's life. There are 5 response options, ranging from 0 ("Never") to 4 ("Always"). The instrument has excellent internal consistency (Cronbach's alpha .86) and a test-retest reliability of around 0.90
Measured: 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.
PTGI is a 21-item instrument which assesses positive outcomes reported by persons who have experienced traumatic events. A 6-point Likert response format is used, so that each statement is rated from "I did not experience this change as a result of my crisis" (scored 0), to "I experienced this change to a very great degree as a result of my crisis" (scored 5). The instrument has an excellent internal consistency (Cronbach's alpha of 0.90) and acceptable test-retest reliability of around 0.71.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Online Computerized Program GroupStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758418
- Sponsor's protocol ID
- UJaumeI
- Acronym
- TAO
- Status last verified
- Sep 2018
- First submitted
- 25 Apr 2016
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22954870Rachyla 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.
PubMed 29855281
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Internet-based CBT Program for Adjustment Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02758418
- Acronym / sponsor ID
- TAO / UJaumeI
- Keywords
- Adjustment disorders online, Psychological Treatments, Information and Communication Technologies, Internet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- Ministerio de Economía y Competitividad, Spain
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 2 May 2016 (estimated)
- 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.
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.
Detailed description
Adjustment Disorder (AD) is a highly prevalent health problem that causes a great suffering and can result in suicidal thinking and/or behavior. However, unlike mood and anxiety disorders, AD has received little attention from scientific community and very few studies have been carried out to develop evidence-based treatments (EBT) for this problem. Besides, although a cognitive behavioral therapy (CBT) protocol is currently available for the treatment of AD, many patients with this diagnosis remain untreated. There is therefore an evident need to design strategies that guarantee the patients receive adequate treatment. A feasible solution might be self-administered computerized CBT (cCBT).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Computerized Program group. | Experimental | Other: TAOIntervention group that uses "TAO" program. |
| 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| TAOAlso: TAO: Adjustment Disorders Online, Online Computerized CBT for Adjustment Disorders, Internet-based CBT for Adjustment Disorders"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 | Online Computerized Program group. |
Primary outcome
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.
Time frame: Up to 12 months
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.
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.
Time frame: Up to 12 months
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).
2 secondary outcomes
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.
Time frame: 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.
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- BackgroundBaños 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.
- BackgroundBotella 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.
- BackgroundQuero 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.
- BackgroundQuero 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: PubMed 22954870Quero 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.
- BackgroundRachyla 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.
- BackgroundMolés 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.
- Derived from this study: PubMed 29855281Rachyla 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.
- Psychology and Technology web platform which will include TAO (Adjustment Disorders Online), an online computerized program for the treatment of Adjustment Disorders.Link provided by the sponsor.
- Laboratory of Psychology and Technology of the Universitat Jaume I.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAO in people with Online Computerized Program Group and Waiting List Control Group, run by Universitat Jaume I at 1 site in Spain.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Results are not available in the source record.
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?
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. (time frame: Up to 12 months). The study lists 2 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 NCT02758418, which also lists 8 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 2 Oct 2018; AzTrials last refreshed its copy on 1 Nov 2026.