NCT02452411

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 25, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

May 20, 2015

Last Update Submit

May 23, 2017

Conditions

Adjustment Disorders

Keywords

InternetAdjustment disordersHomework assignmentsCognitive-Behavioral treatmentOnline therapyEmotional RegulationICT's

Outcome Measures

Primary Outcomes (3)

  • 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.

    12 months

  • 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".

    2 months

  • 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.

    12 months

Secondary Outcomes (3)

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

    12 months

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

    12 months

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

    2 months

Other Outcomes (2)

  • Change in Positive and Negative Affect Scale (PANAS) (Sandín et al., 1999).

    12 months

  • Change in Interference /Severity Scale rated by the Therapist (Adapted from ADIS-IV Interview by Di Nardo, Brown and Barlow 1994).

    12 months

Study Arms (2)

Homework assignments using TEO system

EXPERIMENTAL

Experimental: 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.

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

Homework assignments using Traditional method

EXPERIMENTAL

The 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.

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

Interventions

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

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.

Also known as: Psychological Treatment for Adjustment Disorders
Homework assignments using TEO systemHomework assignments using Traditional method

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Jaume I

Catellon, Castellon, 12006, Spain

Location

Related Publications (10)

  • 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).

    BACKGROUND

  • 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.

    PMID: 14981791BACKGROUND

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

    BACKGROUND

  • 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.

    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

  • 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.

    BACKGROUND

  • 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)

    BACKGROUND

  • 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.

    BACKGROUND

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

    PMID: 24748555BACKGROUND

  • 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.

    PMID: 24096776BACKGROUND

Related Links

MeSH Terms

Conditions

Adjustment DisordersEmotional Regulation

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • Soledad Quero, Lecturer

    University Jaume I, Castellón, Spain

    STUDY DIRECTOR

  • Maria del Mar Molés, Phd Student

    University Jaume I, Castellón, Spain

    STUDY CHAIR

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

May 20, 2015

First Posted

May 22, 2015

Study Start

January 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 25, 2017

Record last verified: 2017-05

Locations

ES(1)