Effectiveness of a Transdiagnostic Internet-based Treatment for Emotional Disorders

NCT02345668 | Completed DMC

• 1 other identifier: UJaumeI09
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety; Depression

Keywords

Transdiagnostic Internet-based Protocol; Treatment as Usual (TAU)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 12 months

• 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.

  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.

  Up to 12 months

Secondary Outcomes (4)

• 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 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

• 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

Other Outcomes (2)

• Change in the EuroQoL-5D (Badía, 1999) at pre, post intervention and at 3 and 12 months follow-ups.

  Up to 12 months

• Client Service Receipt Inventory (CSRI) (Vázquez-Barquero et al., 1997) at pre, at 3 and 12 months follow-ups.

  Up to 12 months

Study Arms (2)

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)

Behavioral: Emotion Regulation Protocol

Treatment as Usual

EXPERIMENTAL

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

Drug: Treatment as Usual (Pharmacological Treatment); Behavioral: Treatment as Usual (Psychological Treatment)

Interventions

Emotion Regulation Protocol BEHAVIORAL

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.

Transdiagnostic Internet-based Treatment

Treatment as Usual (Pharmacological Treatment) DRUG

The Pharmacological Treatment provided by a psychiatrist in the mental health unit.

Treatment as Usual

Treatment as Usual (Psychological Treatment) BEHAVIORAL

The Psychological Treatment provided by a clinical psychologist in the mental health unit.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Jaume I: lead
• Consorcio Hospitalario Provincial de Castellón: collaborator

Study Sites (1)

University Jaume I

Castellon, Castellón, 12071, Spain

Location

Related Publications (6)

• Titov N, Andrews G, Johnston L, Robinson E, Spence J. Transdiagnostic Internet treatment for anxiety disorders: A randomized controlled trial. Behav Res Ther. 2010 Sep;48(9):890-9. doi: 10.1016/j.brat.2010.05.014. Epub 2010 May 24.

  PMID: 20561606 BACKGROUND

• Titov N, Dear BF, Schwencke G, Andrews G, Johnston L, Craske MG, McEvoy P. Transdiagnostic internet treatment for anxiety and depression: a randomised controlled trial. Behav Res Ther. 2011 Aug;49(8):441-52. doi: 10.1016/j.brat.2011.03.007. Epub 2011 Apr 3.

  PMID: 21679925 BACKGROUND

• Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18.

  PMID: 22697453 BACKGROUND

• Gonzalez-Robles A, Roca P, Diaz-Garcia A, Garcia-Palacios A, Botella C. Long-term Effectiveness and Predictors of Transdiagnostic Internet-Delivered Cognitive Behavioral Therapy for Emotional Disorders in Specialized Care: Secondary Analysis of a Randomized Controlled Trial. JMIR Ment Health. 2022 Oct 31;9(10):e40268. doi: 10.2196/40268.

  PMID: 36315227 DERIVED

• Gonzalez-Robles A, Diaz-Garcia A, Garcia-Palacios A, Roca P, Ramos-Quiroga JA, Botella C. Effectiveness of a Transdiagnostic Guided Internet-Delivered Protocol for Emotional Disorders Versus Treatment as Usual in Specialized Care: Randomized Controlled Trial. J Med Internet Res. 2020 Jul 7;22(7):e18220. doi: 10.2196/18220.

  PMID: 32673226 DERIVED

• Gonzalez-Robles A, Garcia-Palacios A, Banos R, Riera A, Llorca G, Traver F, Haro G, Palop V, Lera G, Romeu JE, Botella C. Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial. Trials. 2015 Oct 31;16:488. doi: 10.1186/s13063-015-1024-3.

  PMID: 26519046 DERIVED

Related Links

• Laboratory of Psychology and Technology of the University Jaume I
• Web site of the intervention program

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Therapeutics; Drug Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Cristina Botella, Professor

  University Jaume I, Castellon, Spain

  STUDY DIRECTOR

• Azucena García-Palacios, Professor

  University Jaume I, Castellon, Spain

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 26, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

ES (1)