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Efficacy of a Transdiagnostic Internet-based Protocol in Community Sample

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Universitat Jaume I
Sponsor:
Collaborator:
Ministerio de Economía y Competitividad, Spain
Information provided by (Responsible Party):
Universitat Jaume I
ClinicalTrials.gov Identifier:
NCT02578758
First received: October 15, 2015
Last updated: May 30, 2016
Last verified: October 2015
  Purpose
The aim of this study is to assess the efficacy of a Transdiagnostic Internet-based Protocol (Emotion Regulation Protocol) for the treatment of Emotional Disorders (ED) (major depression disorder, dysthimyc disorder, obsessive-compulsive disorder and four anxiety disorders: panic disorder, agoraphobia, generalized anxiety disorder, and social anxiety disorder) both in terms of efficacy regarding depressive and anxiety symptomatology and its potential impact on higher-order psychological dimensions (neuroticism/behavioral inhibition and low positive affect/behavioral activation) in a community sample. It will also be tested the differential effect of a specific treatment component based on positive psychology techniques in positive affect. The main hypotheses are: 1) both modalities of the protocol (TP and TP+PA) will be more effective than the WL condition in the primary outcome measures. Investigators also expect scores on positive affect to be higher in the TP+PA condition than in the TP condition.

Condition Intervention
Emotional Disorders
Anxiety
Depression
Behavioral: Transdiagnostic internet-based protocol
Behavioral: Transdiagnostic internet-based protocol + positive affect component
Other: Waiting List Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: The Differential Efficacy of a Specific Positive Psychology Components in a Transdiagnostic Internet-based Protocol for the Treatment of Emotional Disorders

Resource links provided by NLM:


Further study details as provided by Universitat Jaume I:

Primary Outcome Measures:
  • Change in the Beck Depression Inventory II (BDI-II) (Beck, Steer, & Brown, 1996) at pre, post intervention and at 3 and 12 months follow-ups. [ Time Frame: Up to 12 months ]
    The BDI-II is one of the most widely used questionnaires to evaluate the severity of depression in pharmacological and psychotherapy trials. It consists of 21 items about the different symptoms characterizing the major depression disorder, summed to obtain the total score, which can be a maximum of 63 points. The instrument has good internal consistency (Cronbach's alpha of 0.76 to 0.95) and a test-retest reliability of around 0.8.

  • Change in the Beck Anxiety Inventory (BAI) (Beck, & Steer, 1990) 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 and has been found to have adequate convergent and divergent validity.


Secondary Outcome Measures:
  • Change in the Obsessive-Compulsive Inventory (OCI-R) (Foa et al., 2002) 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 1 to 4 and organized in 6 dimensions (washing, verification, order, obsession, hoarding and mental neutralization) that assesses obsessive-compulsive behaviors. The OCI-R has a good internal consistency (coefficient alpha between .81 and .93), a good to excellent test-retest reliability (between .57 and .91), a good convergent validity and a solid factor structure.

  • 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.

  • The Positive and Negative Affect Schedule (PANAS) (Watson, Clark y Tellengen, 1988; Sandín et al., 1999) at pre, post intervention and at 3 and 12 months follow-ups. [ Time Frame: Up to 12 months ]
    The PANAS consists of 20 items that evaluate two independent dimensions: positive affect (PA) and negative affect (NA). The range for each scale (10 items on each) is from 10 to 50. The Spanish version has demonstrated high internal consistency (α = 0.89 and 0.91 for PA and NA in women, respectively, and α = 0.87 and 0.89 for PA and NA in men, respectively) in college students.


Other Outcome Measures:
  • Quality of Life Index (QLI) (Mezzich et al., 2000) at pre, post intervention and at 3 and 12 months follow-ups. [ Time Frame: Up to 12 months ]
    It consists of 10 items that evaluate perceived well-being in different areas (physical, psychological/emotional, occupational functioning, interpersonal functioning, among others). The test-retest reliability correlation coefficient of the Spanish version of the QLI mean score was .89.


Estimated Enrollment: 252
Study Start Date: September 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transdiagnostic Internet-Based Protocol
Intervention group that carries out the Transdiagnostic Internet-Based Protocol and receives support by the therapist (a brief weekly two-minute phone call without clinical content and two weekly orientative text messages).
Behavioral: Transdiagnostic internet-based protocol
Transdiagnostic internet-based protocol is an Internet-based Protocol for ED, 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 12 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: Transdiagnostic Internet-Based Protocol+Positive Affect
Intervention group that carries out the Transdiagnostic Internet-Based Protocol+Positive Affect component and receives support by the therapist (a brief weekly two-minute phone call without clinical content and two weekly orientative text messages).
Behavioral: Transdiagnostic internet-based protocol + positive affect component
Transdiagnostic internet-based protocol + positive affect component is an Internet-based protocol for ED. This protocol contains several transdiagnostic 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) and a specific positive affect regulation component. These components are organized in 16 treatment 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; Learning to move on; Learning to enjoy; Learning to live; Living and learning; and Relapse Prevention.
Waiting List Control Group
Participants in a 18-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the wating list period.
Other: Waiting List Control Group
Participants in a 18-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the wating list period.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be 18 years old or older.
  • Meeting the DSM-IV diagnosis criteria of emotional disorder (panic disorder, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02578758

Contacts
Contact: Cristina Botella, Professor 964387639 ext 763 botella@uji.es
Contact: Azucena García-Palacios, Professor 964387640 ext 7640 azucena@uji.es

Locations
Spain
University Jaume I Recruiting
Castellón, Spain, 12071
Contact: Cristina Botella, Professor    +34 964 38 76 39 ext 76 39    botella@psb.uji.es   
Contact: Azucena García, Professor    +34 964 38 76 40 ext 76 40    azucena@uji.es   
Principal Investigator: Cristina Botella, Professor         
Principal Investigator: Azucena García-Palacios, Professor         
Sub-Investigator: Amanda Díaz García, PhD Student         
Sponsors and Collaborators
Universitat Jaume I
Ministerio de Economía y Competitividad, Spain
Investigators
Study Director: Cristina Botella, Professor University Jaume I, Castellon, Spain
Study Chair: Amanda Díaz, PhD Student University Jaume I, Castellon, Spain
  More Information

Additional Information:
Publications:
Responsible Party: Universitat Jaume I
ClinicalTrials.gov Identifier: NCT02578758     History of Changes
Other Study ID Numbers: UJAUMEI014
Study First Received: October 15, 2015
Last Updated: May 30, 2016

Keywords provided by Universitat Jaume I:
Transdiagnostic Internet-based Protocol
Positive affect regulation

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 27, 2017