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Adjustment DisordersNCT02452411

Efficacy of Two Ways of Applying Homework Assignments in the Treatment of Adjustment Disorders

A study testing Cognitive Behavioral Treatment approach supported by virtual reality and positive psychology strategies. in people with Adjustment Disorders, run by Universitat Jaume I at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the differential efficacy of two ways of applying homework assignments in the treatment of Adjustment Disorders: 1) using an Internet-based emotional regulation therapy system (TEO) and 2) in the traditional way (using reading and audio materials). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Adjustment Disorders
What is being tested?
Cognitive Behavioral Treatment approach supported by virtual reality and positive psychology strategies.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
Jan 2013to Apr 2016
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

  • 18-65 years old
  • To meet current DSM-IV-TR criteria for Adjustment Disorder
  • Be able to use a computer and having an Internet connection at home.

Who cannot join

  • A severe mental disorder on Axis I: abuse or dependence of alcohol or other substances, psychotic disorder or Schizophrenia.
  • A severe personality disorder or illness
  • Presence of risk suicide
  • Be receiving other psychological treatment.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University Jaume I

    Catellon, Castellon, 12006

Other trials in Spain

About this study

Official title: Differential Efficacy of Two Ways of Applying Homework Assignments in the Treatment of Adjustment Disorders: Application Supported by Information and Communication Technologies Versus Traditional Application

The purpose of this study is to determine the differential efficacy of two ways of applying homework assignments in the treatment of Adjustment Disorders: 1) using an Internet-based emotional regulation therapy system (TEO) and 2) in the traditional way (using reading and audio materials).

The principal hypothesis is that both treatment conditions (TEO and Traditional) will show a similar efficacy. All participants will improve significantly on all outcome measures, regardless the type of homework assigned (TEO or Traditional) with no differences between them.

Read the detailed description

Adjustment Disorders (AD) are very prevalent in primary care and hospital settings. The available data indicate that the percentage of adults suffering from AD in primary care ranges from 5% to 21%. Furthermore, AD is an important public mental health problem in economic terms. Very frequently the distress and activity deterioration associated to this problem result in a decrease of work performance, causing a high percentage of sick leaves. However, nowadays there are no evidence-based psychological treatments for this problem, and only general treatment guidelines are available for this problem. For these reason, a Cognitive-Behavioral Treatment (CBT) supported by Virtual Reality (VR; EMMA system) was developed and has already shown its utility to treat this disorder. Information and Communication Technologies (ICTs) are useful tools for offer and improve therapeutic services. VR offers a safe and flexible environment in where the person can explore and manage their problems in a controlled and gradual way. Computerized programs allow reducing the contact time between therapist and patient, so it can reach patients who would not receive treatment otherwise. ICTs have been mainly used within the therapeutic context; specifically many studies have been centered on how to use the technologies to deliver the treatment. As far as the investigators know, no study analyzes the ICTs contribution in the homework assignments field. CBT approach provides a crucial role to homework assignments because it allows reinforcing and supporting the patients along the therapy. More studies examining the utility of the application of ICTs for the treatment of AD are needed. Furthermore, the application of the homework assignments component through the Internet is also relevant. It is necessary an adaptive and flexible system that allows adjusting the therapeutic homework on every patient's characteristics and needs, attending to the specific meaning of his/her problem. This would be a way to facilitate the patient's treatment adherence and in consequence improve the effectiveness of the AD treatment. In the present study the differential efficacy of two ways of applied homework assignments for the treatment of AD is explored with a between subject randomized controlled trial. After the evaluation phase, all participants receive a 6-8 sessions weekly CBT program. After each treatment session, they practice their assigned homework (using TEO or in the Traditional way) and they assess several clinical variables. After treatment completion, a post-treatment assessment will be carried out as well as follow-up assessments at 6- and 12-month.

Being tested
Cognitive Behavioral Treatment approach supported by virtual reality and positive psychology strategies.
Keywords
Internet, Adjustment disorders, Homework assignments, Cognitive-Behavioral treatment, Online therapy, Emotional Regulation, ICT's
Medical subject headings
Adjustment Disorders, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Treatment approach supported by virtual reality and positive psychology strategies.Behavioural

    Also called Psychological Treatment for Adjustment Disorders

    The CBT program consists of 6 weekly sessions (and 2 additional ones depending on the patient's needs) with the following main therapeutic components: educational component, exposure/processing of the stressful event with VR (EMMA's World) and relapse prevention. EMMA's World is an open and flexible VR system that uses symbols (e.g., 3D-objects, pictures, sounds) to reflect and evoke the negative emotions associated to the stressful event. Also, several strategies from Positive Psychology (e.g., My best virtues or strengths exercise) and others based on Neimeyer's (2000) suggestions for pathological grief (e.g., projection letter to the future) are also included in the protocol.

Study groups in NCT02452411
Study groupRoleWhat they receive
Homework assignments using TEO systemExperimentalExperimental: Homework assignments using TEO system. It is an internet-based system which allows the therapist to create homework sessions using multimedia materials (videos, images, texts, and narratives) and to offer and present this material to the patients through the Internet. Participants receive a CBT treatment for adjustment disorder supported by virtual reality and they do the homework assignments component using TEO at home over the Internet.
Receives: Behavioral: Cognitive Behavioral Treatment approach supported by virtual reality and positive psychology strategies.
Homework assignments using Traditional methodExperimentalThe traditional way of applying homework assignments consists of reading and writing materials and audio session records. Participants receive a CBT treatment supported by virtual reality for adjustment disorder and they do the homework assignments component at home using traditional materials.
Receives: Behavioral: Cognitive Behavioral Treatment approach supported by virtual reality and positive psychology strategies.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996)

    BDI-II is one of the most widely used questionnaires to evaluate the severity of depression in pharmacological and psychotherapy trials. It consists of 21 items about the different symptoms characterizing the major depression disorder, summed to obtain the total score, which 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: 12 months

  2. Change in Self-efficacy before and after homework assignment (Labpsitec 2010)

    The participant assesses perceived self-efficacy to cope with her problem before and after practicing the homework assigned in both conditions (TEO and Traditional) in a scale from 1= "Nothing at all" to 7= "Totally".

    Measured: 2 months

  3. Change in Inventory of Stress and Loss (Mor, Molés, Rachyla and Quero, 2015)

    It is an adaptation of the Complicated Grief Inventory (CGI; Prigerson, 1995). It includes 17 items that assess to which extent the lost person/situation interferes in the individual's life on a scale ranging from 0 ("Never") to 4 ("Always"). The instrument has excellent internal consistency (Cronbach's alpha 0.86) and a test-retest reliability of around 0.9.

    Measured: 12 months

Secondary outcomes (3)

  1. Change in Posttraumatic Growth Inventory (PTGI) (Tedeschi y Calhoun, 1996)

    • It is an instrument that assesses positive outcomes reported by people who have experienced a traumatic event. For each of the statements, participants indicate the degree to which this change occurred in their life as a result of their crisis, using the scale ranging 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 0,90) and acceptable test-retest reliability of around 0.71.

    Measured: 12 months

  2. Change in Avoidance, Emotional Distress and Belief Scales (Adapted from Marks and Mathews 1979).

    This instrument establishes the main situations and behaviors evoking distress, the intrusive thoughts or images, the predominant negative emotions, and the irrational thoughts related to the stressor event. The patient assesses using 0-10 scales (0= "Nothing at all"; 10= "Totally") the degree of avoidance and distress related to the situations/behaviors, thoughts/images, and emotions, as well as the degree of belief in the irrational thoughts

    Measured: 12 months

  3. Change in Mood State before and after homework assignments (Labpsitec 2010)

    The participant assesses mood state before and after practicing the homework assigned in both conditions (TEO and Traditional) on a 7-point Likert scale using faces reflecting different mood states.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2015 (estimated)
  2. Study startJan 2013
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02452411
Sponsor's protocol ID
UJaumeI010
Status last verified
May 2017
First submitted
20 May 2015
Last updated
25 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Quero S, Botella C, Andreu-Mateu S, Baños R, Molés M. An adaptative Virtual Reality System for the treatment of Adjustment Disorder: 12-Months follow-up efficacy (November 2013). Symposium presented in ABCT's 47th Annual Convention. Nashville (EE.UU).

  • Rochlen AB, Zack JS, Speyer C. Online therapy: review of relevant definitions, debates, and current empirical support. J Clin Psychol. 2004 Mar;60(3):269-83. doi: 10.1002/jclp.10263.

    PubMed 14981791

  • Beck, J. y Tompkins, M. Handbook of Homework Assignments in Psychotherapy. Nueva York. Springer. 2007

  • Botella C, Baños R.M & Guillén V. Creciendo en la adversidad. Una propuesta de tratamiento para los trastornos adaptativos. In C. Vázquez & G. Hervás (Eds.), Psicología Positiva aplicada. Bilbao: DDB, 2008.

  • Quero, S., Molés, M., Pérez-Ara, M.A., Botella, C & Baños, R.M. An Online Emotional System to Deliver Homework Assignments for Treating Adjustment Disorders. En B.K. Wiederhold y G. Riva (Eds.), Annual Review of Cybertherapy and Telemedicine 2012. Advanced Technologies in the Behavioral, Social and Neurosciences (pp. 273-278). Amsterdam: Interactive Media Institute e IOS Press.

  • Baños, R. M., Guillen, V., Quero, S., García-Palacios, A., Alcaniz, M., & Botella, C. (2011). A virtual reality system for the treatment of stress-related disorders: A preliminary analysis of efficacy compared to a standard cognitive behavioral program. International Journal of Human-Computer Studies, 69 (9) 602-613.

  • Quero, S., Andreu-Mateu, S., Moragrega, I., Baños, R.M., Molés, M., Nebot, S. y Botella, C. (en revisión). 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 (en prensa)

  • Andreu-Mateu, S., Botella, C., Quero, S., Guillen, V., & Baños, R. (2012). La utilización de la realidad virtual y estrategias de psicología positiva en el tratamiento de los trastornos adaptativos. Behavioral Psychology/ Psicologia Conductual, 20 (2) 323-348.

  • Casey P. Adjustment disorder: new developments. Curr Psychiatry Rep. 2014 Jun;16(6):451. doi: 10.1007/s11920-014-0451-2.

    PubMed 24748555

  • Maercker A, Brewin CR, Bryant RA, Cloitre M, van Ommeren M, Jones LM, Humayan A, Kagee A, Llosa AE, Rousseau C, Somasundaram DJ, Souza R, Suzuki Y, Weissbecker I, Wessely SC, First MB, Reed GM. Diagnosis and classification of disorders specifically associated with stress: proposals for ICD-11. World Psychiatry. 2013 Oct;12(3):198-206. doi: 10.1002/wps.20057.

    PubMed 24096776

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Treatment approach supported by virtual reality and positive psychology strategies. in people with Adjustment Disorders, 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 3 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: finished, as of the sponsor's last update on 25 May 2017. 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?

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?

Change in Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996) (time frame: 12 months). The study lists 3 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 NCT02452411, which also lists 10 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 25 May 2017.

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