Efficacy of Two Ways of Applying Homework Assignments in the Treatment of Adjustment Disorders
Condition: Adjustment Disorders
MeSH terms: Adjustment Disorders
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioral Treatment approach supported by virtual reality and positive psychology strategies.
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): Psychological Treatment for Adjustment Disorders
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Internet; Adjustment disorders; Homework assignments; Cognitive-Behavioral treatment; Online therapy; Emotional Regulation; ICT's