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

Adjustment Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02452411
• Other study ID #: UJaumeI010
• Status: Completed
• Phase: N/A
• First received: May 20, 2015
• Last updated: May 23, 2017
• Start date: January 2013
• Est. completion date: April 2016

Study information

• Verified date: May 2017
• Source: Universitat Jaume I
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjustment Disorders
• Disease

Intervention

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.

Locations

Country	Name	City	State
Spain	University Jaume I	Catellon	Castellon

Sponsors (1)

Lead Sponsor	Collaborator
Universitat Jaume I

Country where clinical trial is conducted

Spain, 

References & Publications (10)

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

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.

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.

Casey P. (2014). Adjustment Disorder: New Developments. Current Psychiatry report, 451, 1-8.

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. — View Citation

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).

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)

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.

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Positive and Negative Affect Scale (PANAS) (Sandín et al., 1999).	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
Other	Change in Interference /Severity Scale rated by the Therapist (Adapted from ADIS-IV Interview by Di Nardo, Brown and Barlow 1994).	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
Primary	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
Primary	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
Primary	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	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.	12 months
Secondary	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	12 months
Secondary	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.	2 months

External Links

•   Laboratory of Psychology and Technology of the University Jaume I
•   Online Emotional Therapy system (TEO)