跳至主要内容
临床试验/NCT02345668
NCT02345668已完成不适用

Effectiveness of a Transdiagnostic Internet-based Treatment for Emotional Disorders vs Treatment as Usual in Specialized Care: a Randomized Controlled Trial

Universitat Jaume I1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Change in the Beck Depression Inventory (BDI-II) (Beck, Steer, & Brown, 1990; Sanz, Navarro, & Vázquez, 2003) at pre, post intervention and at 3 and 12 months follow-ups.

研究概览

简要总结

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).

详细描述

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.).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being aged between 18 and 70 years old.
  • Meeting the DSM-IV diagnosis criteria of emotional disorder (panic disorder with or without agoraphopia, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, major depression disorder and dysthimia).
  • Providing written, informed consent.
  • Being able to understand and read Spanish.
  • Having daily acces to the Internet in their natural environment.

排除标准

  • Being diagnosed a severe mental disorder (people with the following mental disorders will be excluded from the study: schizophrenia, bipolar disorder and personality disorders from clusters A and B).
  • Being diagnosed an alcohol and/or substance dependence disorder.
  • The presence of high suicidal risk.
  • A medical disease or condition which prevent the participant from carry out the psychological treatment.
  • Receiving another psychological treatment while the study is still ongoing.
  • The increase and/or changes in the medication of participants receiving pharmacological treament during the study.

研究组 & 干预措施

Transdiagnostic Internet-based Treatment

Experimental

Intervention group that carries out the Emotion Regulation Protocol and receives support by the therapist (a brief weekly two-minute phone call without clinical content and two weekly orientative text messages)

干预措施: Emotion Regulation Protocol (Behavioral)

Treatment as Usual

Experimental

Intervention group that receives psychological and/or pharmacological treatment from a clinician of the mental health unit.

干预措施: Treatment as Usual (Pharmacological Treatment) (Drug)

Treatment as Usual

Experimental

Intervention group that receives psychological and/or pharmacological treatment from a clinician of the mental health unit.

干预措施: Treatment as Usual (Psychological Treatment) (Behavioral)

结局指标

主要结局

Change in the Beck Depression Inventory (BDI-II) (Beck, Steer, & Brown, 1990; Sanz, Navarro, & Vázquez, 2003) at pre, post intervention and at 3 and 12 months follow-ups.

时间窗: Up to 12 months

It is one of the most widely used questionnaires to evaluate depression severity in pharmacological and psychotherapy trials. It consists of 21 items about the different symptoms characterizing major depression disorder, added together to obtain the total score, which can be a maximum of 63 points. The instrument has good internal consistency (α = 0.76 to 0.95). The Spanish version of this instrument has also shown a high internal consistency (α = 0.87) for both the general and clinical populations (α = .89) are coded from 0 to 4, added together to obtain a total score ranging from 0 to 20. The Spanish version has shown shown good internal consistency (α = 0.86), and convergent and discriminant validity.

Change in the Beck Anxiety Inventory (BAI) (Beck, & Steer, 1990; Magán, Sanz, & García-Vera, 2008) at pre, post intervention and at 3 and 12 months follow-ups.

时间窗: Up to 12 months

The BAI is a 21-item self-report measure designed to assess anxiety. Each item has a 4-point Severity scale (e.g., not at all, mildly, moderately, and severely) that addresses symptoms experienced during the past week. The internal consistency of the BAI has been found to range from .85 to .94.

次要结局

  • Change in Obsessive-Compulsive Inventory (OCI-R) (Foa et al., 2002; Fullana et al., 2004) at pre, post intervention and at 3 and 12 months follow-ups.(Up to 12 months)
  • Change in the Self-Reported Panic Disorder Severity Scale (PDSS-SR) (Houck, Spiegel, Shear, & Rucci, 2002) at pre, post intervention and at 3 and 12 months follow-ups.(Up to 12 months)
  • Change in the Social Interaction Anxiety Inventory (SIAS) (Mattick y Clarke, 1998) at pre, post intervention and at 3 and 12 months follow-ups.(Up to 12 months)
  • Change in the Pen State Worry Questionnaire (PSWQ) (Meyer, Miller, Metzger, & Borkovec, 1990) at pre, post intervention and at 3 and 12 months follow-ups.(Up to 12 months)

研究者

发起方
Universitat Jaume I
申办方类型
Other
责任方
Sponsor

研究点 (1)

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