Overview

This trial is active, not recruiting.

Condition adjustment disorders
Treatment cognitive behavioral treatment approach supported by virtual reality and positive psychology strategies.
Sponsor Universitat Jaume I
Start date January 2013
End date April 2016
Trial size 50 participants
Trial identifier NCT02452411, UJaumeI010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(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.
cognitive behavioral treatment approach supported by virtual reality and positive psychology strategies. 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.
(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.
cognitive behavioral treatment approach supported by virtual reality and positive psychology strategies. 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.

Primary Outcomes

Measure
Change in Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996)
time frame: 12 months
Change in Self-efficacy before and after homework assignment (Labpsitec 2010)
time frame: 2 months
Change in Inventory of Stress and Loss (Mor, Molés, Rachyla and Quero, 2015)
time frame: 12 months

Secondary Outcomes

Measure
Change in Posttraumatic Growth Inventory (PTGI) (Tedeschi y Calhoun, 1996)
time frame: 12 months
Change in Avoidance, Emotional Distress and Belief Scales (Adapted from Marks and Mathews 1979).
time frame: 12 months
Change in Mood State before and after homework assignments (Labpsitec 2010)
time frame: 2 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Universitat Jaume I.