Effectiveness of a Transdiagnostic Internet-based Treatment for Emotional Disorders
Condition: Anxiety; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol
      (Emotion Regulation Protocol) for the treatment of unipolar mood disorders (major depression
      and dysthimia) four anxiety disorders (Panic disorder, agoraphobia, generalized anxiety
      disorder and social anxiety disorder) and obsessive-compulsive disorder in comparison with
      Treatment as Usual in specialized care (Spanish public mental health system).
    

Detailed description: 
      Emotional disorders (ED) (anxiety and mood disorders) are among the most prevalent mental
      disorders, with a life prevalence of 29% and comorbidity rates that range between 40 and 80%.
      If they are not adequately treated the course is often chronic, and them significantly affect
      important functioning areas such as work and social relationships. Thus, these data strongly
      suggest efficacious and efficient treatments are needed in order to address this important
      health problem. The classification and differentiation of mental disorders carried out in
      manuals like the DSM and the ICD has played an important role in the emphasis placed on the
      research about the treatment of specific disorders; however, it has also been a problem in
      the dissemination of evidenced-based treatments due to the difficulties in training the
      clinicians in the variety of the available disorder-specific programs. In fact, less than 50%
      of people suffering from emotional disorders receive a psychological treatment; and this is
      also accounted for by its costs and time of application. As a consequence, many people decide
      not to search for psychological treatment. In addition, epidemiological studies have shown
      that at least 55% of people suffering from an anxiety disorder suffer from another anxiety
      disorder at the moment of the assessment, and this prevalence rate is up to 76% when
      different lifespan diagnoses are taken into account. This high comorbidity rate indicates
      that the different ED share important characteristics and it has been proposed that this
      overlapping is accounted for by common biological and psychological vulnerabilities that
      along with psychosocial stress factors leads to different manifestations of the same
      vulnerability, i. e., the different mood and anxiety disorders. Thus, a Transdiagnostic
      approach could help overcome these barriers.

      Transdiagnostic approaches have implications in the treatment of psychological disorders as a
      number of treatment protocols have been developed based on this perspective. Clark has
      distinguished three perspectives in transdiagnostic cognitive-behavioral therapy: a) The
      transdiagnostic practice, a pragmatic perspective that includes components of various
      disorder-specific intervention protocols whose aim is to determine which are the active
      components in samples with those disorders. The contributions of Norton, Andrews and Titov,
      and the study: Coordinated Anxiety Learning and Management (CALM) belong to this category. b)
      The transdiagnostic theory, that specifies a theoretical framework which outlines the common
      psychological constructs that influence the maintenance of ED. For instance, the tripartite
      model of anxiety and depression, with positive and negative affect as relevant constructs. c)
      The Unified Protocol. The Barlow's team has designed a protocol, adequate for the treatment
      of ED which focuses on four essential aspects: to increase present-focused emotional
      awareness, to identify and modify emotional avoidance patterns, to promote the cognitive
      flexibility and to facilitate exposure to avoided situations and sensations.

      Another aspect that could enhance the dissemination of evidence-based treatments as well as
      considerably reduce the costs is the use of the Internet. A number of sistematic reviews has
      shown that Internet-based treatments yield similar results when compared to face-to-face
      therapy. Nevertheless, most of these programs are focused on a single disorder since a few
      Transdiagostic Internet-based treatments have been developed and tested by means of
      randomized controlled trials so far. Furthermore, no studies on efficacy of Internet-based
      Transdiagnostic vs Treatment as usual (TAU) have been carried out in specialized care.
      Therefore, we have developed a Transdiagnostic Internet-based protocol treatment (Emotion
      Regulation Protocol) based on the Unified Protocol proposed by Barlow, that also includes
      components of emotion regulation and acceptance.

      The aim of this study will be to test the efficacy of a Transdiagnostic Internet-based
      protocol (Emotion Regulation Protocol) for the treatment of emotional disorders by means of a
      randomized controlled trial in a sample made up of participants from specialized care of the
      Spanish public mental health system. The study will include two conditions: a)
      Transdiagnostic Internet-based treatment protocol and b) TAU. The main hypothesis is that the
      Transdiagnostic protocol will be more efficacious than TAU and that will obtain a good
      acceptance by patients and mental health professionals. We also expect the online
      Transdiagnostic protocol to be more efficient when compared with TAU (e. g., a significant
      greater number of patients which receive a psychological treatment, a significant reduction
      of the waiting lists and costs such as hours of clinical assistance and hours of face-to-face
      treatment, etc.).
    

Intervention name(s): Emotion Regulation Protocol; Treatment as Usual (Pharmacological Treatment); Treatment as Usual (Psychological Treatment)
Intervention type(s): Behavioral; Drug; Behavioral
Intervention description(s): Emotion Regulation Protocol is an Internet-based Self-administered Protocol for emotional disorders, which will allow the individual to learn and practice adaptive ways to regulate their emotions from a transdiagnostic perspective. The protocol contains the following components: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention, which are organized in twelve modules: Emotional disorders and emotion regulation; Motivation for change; Understanding the role of emotions; The acceptance of emotional experiences; Practicing the acceptance; Learning to be flexible; Practicing the cognitive flexibility; The emotional avoidance; Emotion driven behaviors; Accepting and facing physical sensations; Facing emotions in the contexts in which they occur; and Relapse Prevention.; The Pharmacological Treatment provided by a psychiatrist in the mental health unit.; The Psychological Treatment provided by a clinical psychologist in the mental health unit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Transdiagnostic Internet-based Protocol; Treatment as Usual (TAU)