Clinical trial NCT02452411: Efficacy of Two Ways of Applying Homework Assignments in the Treatment of Adjustment Disorders
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adjustment Disorders
Keywords: Internet
Adjustment disorders
Homework assignments
Cognitive-Behavioral treatment
Online therapy
Emotional Regulation
ICT's
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2015-05-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996)
timeFrame: 12 months
measure: Change in Self-efficacy before and after homework assignment (Labpsitec 2010)
timeFrame: 2 months
measure: Change in Inventory of Stress and Loss (Mor, Molés, Rachyla and Quero, 2015)
timeFrame: 12 months
Secondary outcomes:
measure: Change in Posttraumatic Growth Inventory (PTGI) (Tedeschi y Calhoun, 1996)
timeFrame: 12 months
measure: Change in Avoidance, Emotional Distress and Belief Scales (Adapted from Marks and Mathews 1979).
timeFrame: 12 months
measure: Change in Mood State before and after homework assignments (Labpsitec 2010)
timeFrame: 2 months
Other outcomes:
measure: Change in Positive and Negative Affect Scale (PANAS) (Sandín et al., 1999).
timeFrame: 12 months
measure: Change in Interference /Severity Scale rated by the Therapist (Adapted from ADIS-IV Interview by Di Nardo, Brown and Barlow 1994).
timeFrame: 12 months
Locations:
city: Catellon
country: Spain
facility: University Jaume I
state: Castellon
Study officials:
affiliation: University Jaume I, Castellón, Spain
name: Soledad Quero, Lecturer
role: STUDY_DIRECTOR
affiliation: University Jaume I, Castellón, Spain
name: Maria del Mar Molés, Phd Student
role: STUDY_CHAIR
References:
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).
citation: 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.
citation: Beck, J. y Tompkins, M. Handbook of Homework Assignments in Psychotherapy. Nueva York. Springer. 2007
citation: 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.
citation: 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.
citation: 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.
citation: 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)
citation: 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.
citation: Casey P. Adjustment disorder: new developments. Curr Psychiatry Rep. 2014 Jun;16(6):451. doi: 10.1007/s11920-014-0451-2.
citation: 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.