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

May 23, 2017 updated by: Universitat Jaume I

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Castellon
      • Catellon, Castellon, Spain, 12006
        • University Jaume I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Homework assignments using TEO system
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.
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.
Other Names:
  • Psychological Treatment for Adjustment Disorders
EXPERIMENTAL: Homework assignments using Traditional method
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.
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.
Other Names:
  • Psychological Treatment for Adjustment Disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996)
Time Frame: 12 months
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)
Time Frame: 2 months
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)
Time Frame: 12 months
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Positive and Negative Affect Scale (PANAS) (Sandín et al., 1999).
Time Frame: 12 months
The PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). The range for each scale (10 items on each) is from 10 to 50. The Spanish version has demonstrated high internal consistency (0.89 to 0.91 for PA and NA, respectively, in women, and 0.87 and 0.89 for PA and NA, respectively, in men) in college students (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).
Time Frame: 12 months
The therapist makes a global evaluation of the patient's interference and severity on a scale from 0 ("No impaired or without symptoms") to 8 ("Severely impaired or Very severe").
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Jaume I

Investigators

  • Study Director: Soledad Quero, Lecturer, University Jaume I, Castellón, Spain
  • Study Chair: Maria del Mar Molés, Phd Student, University Jaume I, Castellón, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

May 20, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (ESTIMATE)

May 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UJaumeI010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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