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Trial record 6 of 21 for:    "Depressive Disorder" [DISEASE] AND Behavioral AND Spanish | ( Map: Spain )

Effectiveness of a Transdiagnostic Internet-based Treatment for Emotional Disorders

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ClinicalTrials.gov Identifier: NCT02345668
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Consorcio Hospitalario Provincial de Castellón
Information provided by (Responsible Party):
Universitat Jaume I

Brief 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).

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Emotion Regulation Protocol Drug: Treatment as Usual (Pharmacological Treatment) Behavioral: Treatment as Usual (Psychological Treatment) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of a Transdiagnostic Internet-based Treatment for Emotional Disorders vs Treatment as Usual in Specialized Care: a Randomized Controlled Trial
Study Start Date : April 2015
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Transdiagnostic Internet-based Treatment
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)
Behavioral: Emotion Regulation Protocol
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.

Experimental: Treatment as Usual
Intervention group that receives psychological and/or pharmacological treatment from a clinician of the mental health unit.
Drug: Treatment as Usual (Pharmacological Treatment)
The Pharmacological Treatment provided by a psychiatrist in the mental health unit.

Behavioral: Treatment as Usual (Psychological Treatment)
The Psychological Treatment provided by a clinical psychologist in the mental health unit.




Primary Outcome Measures :
  1. 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. [ Time Frame: 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.

  2. 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. [ Time Frame: 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.


Secondary Outcome Measures :
  1. 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. [ Time Frame: Up to 12 months ]
    The OCI-R is a scale made up of 18 items rated from 1 to 4 and organized in six dimensions (washing, verification, order, obsession, hoarding and mental neutralization) that assess obsessive-compulsive behaviors. The OCI-R has showed good internal consistency (α = .81 to .93), good to excellent test-retest reliability (α = .57 to .91) and good convergent validity. The internal consistency of the Spanish version of the OCI-R has been found to be good (α = .86)

  2. 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. [ Time Frame: Up to 12 months ]
    The scale measures the severity of the panic disorder through measures of panic attack frequency, distress during the panic attacks, anticipatory anxiety, fear and agoraphobic avoidance, fear and avoidance of physical sensations, and work and social impairment. The reliability of the scale has proved to be excellent (coefficient alpha of .917) as also has done the test-retest reliability (ICC = .81).

  3. 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. [ Time Frame: Up to 12 months ]
    It is a questionnaire that evaluates the worry as an incontrollable, generalized and excessive experience. The psychometric properties of the PSWQ have proved to be good, with an internal consistency ranging from .91 to .95, and a good validity and test-retest reliability.

  4. Change in the Social Interaction Anxiety Inventory (SIAS) (Mattick y Clarke, 1998) at pre, post intervention and at 3 and 12 months follow-ups. [ Time Frame: Up to 12 months ]
    This scale is made up of twenty items rated 0 to 4 that asses the anxiety experienced by the patient in social interactive situations. The scale has a good internal consistency (alpha coefficient between .88 and .94), good test-retest and discriminant reliability, as well as appropriate construct validity.


Other Outcome Measures:
  1. Change in the EuroQoL-5D (Badía, 1999) at pre, post intervention and at 3 and 12 months follow-ups. [ Time Frame: Up to 12 months ]
    Generic instrument of health-related quality of life. It consists of two parts: Part 1 assesses self-reported problems in each of five domains: mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each domain is divided into three levels of severity corresponding to no problems, some problems, and extreme problems Part 2 records the subject's self-assessed health on a VAS, a 10 cm vertical line on which the best and worst imaginable health states score 100 and 0, respectively.

  2. Client Service Receipt Inventory (CSRI) (Vázquez-Barquero et al., 1997) at pre, at 3 and 12 months follow-ups. [ Time Frame: Up to 12 months ]
    The CSRI is an interview that allows the clinician to collect quantitative and qualitative information about the use of health and social services, as well as information about the economic impact of the disease (e. g., time off sick from work due to the disease). The CSRI takes about 20 minutes to be administered and includes multiple choice items as well as open questions. The version utilized in this study was designed to assess the use of services in the previous twelve months.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345668


Locations
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Spain
University Jaume I
Castellón, Spain, 12071
Sponsors and Collaborators
Universitat Jaume I
Consorcio Hospitalario Provincial de Castellón
Investigators
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Study Director: Cristina Botella, Professor University Jaume I, Castellon, Spain
Study Director: Azucena García-Palacios, Professor University Jaume I, Castellon, Spain
Study Chair: Francisco Traver Consorcio Hospitalario Provincial de Castellón, Spain
Study Chair: Gonzalo Haro Consorcio Hospitalario Provincial de Castellón, Spain
Study Chair: Ginés Llorca Consorcio Hospitalario Provincial de Castellón, Spain
Study Chair: Alberto Gonzalez-Robles, PhD Student University Jaume I, Castellon, Spain

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitat Jaume I
ClinicalTrials.gov Identifier: NCT02345668     History of Changes
Other Study ID Numbers: UJaumeI09
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Keywords provided by Universitat Jaume I:
Transdiagnostic Internet-based Protocol
Treatment as Usual (TAU)
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms