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
|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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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.
- 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)
- 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).
- 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.
- 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.
- 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.
- 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.
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
|University Jaume I|
|Castellón, Spain, 12071|
|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|