Efficacy of a Transdiagnostic Internet-based Protocol in Community Sample

NCT02578758 | Completed DMC

• 1 other identifier: UJAUMEI014
• Study Type: interventional
• Target: 252
• 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 Emotional Disorders (ED) (major depression disorder, dysthymic 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.

Conditions

Emotional Disorders; Anxiety; Depression

Keywords

Transdiagnostic Internet-based Protocol; Positive affect regulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 12 months

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

  Up to 12 months

Secondary Outcomes (5)

• Change in the Obsessive-Compulsive Inventory (OCI-R) (Foa et al., 2002) 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

• 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.

  Up to 12 months

Other Outcomes (1)

• Quality of Life Index (QLI) (Mezzich et al., 2000) at pre, post intervention and at 3 and 12 months follow-ups.

  Up to 12 months

Study Arms (3)

Transdiagnostic Internet-Based Protocol

EXPERIMENTAL

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+Positive Affect

EXPERIMENTAL

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

Waiting List Control Group

OTHER

Participants in a 18-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the waiting list period.

Other: Waiting List Control Group

Interventions

Transdiagnostic internet-based protocol BEHAVIORAL

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.

Transdiagnostic Internet-Based Protocol

Transdiagnostic internet-based protocol + positive affect component BEHAVIORAL

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.

Transdiagnostic Internet-Based Protocol+Positive Affect

Waiting List Control Group OTHER

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.

Waiting List Control Group

Eligibility Criteria

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

You may qualify if:

• Be 18 years old or older.
• Meeting the DSM-IV diagnosis criteria of emotional disorder (panic disorder, agoraphobia, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, major depression disorder and dysthymia).
• Providing written, informed consent.
• Being able to understand and read Spanish.
• Having daily access 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 treatment during the study.

Sponsors & Collaborators

• Universitat Jaume I: lead
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Universitat Jaume I

Castellon, Castelló, 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

• Carl JR, Soskin DP, Kerns C, Barlow DH. Positive emotion regulation in emotional disorders: a theoretical review. Clin Psychol Rev. 2013 Apr;33(3):343-60. doi: 10.1016/j.cpr.2013.01.003. Epub 2013 Jan 12.

  PMID: 23399829 BACKGROUND

• Diaz-Garcia A, Gonzalez-Robles A, Garcia-Palacios A, Fernandez-Alvarez J, Castilla D, Breton JM, Banos RM, Quero S, Botella C. Negative and Positive Affect Regulation in a Transdiagnostic Internet-Based Protocol for Emotional Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Feb 1;23(2):e21335. doi: 10.2196/21335.

  PMID: 33522977 DERIVED

• Diaz-Garcia A, Gonzalez-Robles A, Fernandez-Alvarez J, Garcia-Palacios A, Banos RM, Botella C. Efficacy of a Transdiagnostic internet-based treatment for emotional disorders with a specific component to address positive affect: Study protocol for a randomized controlled trial. BMC Psychiatry. 2017 Apr 20;17(1):145. doi: 10.1186/s12888-017-1297-z.

  PMID: 28424068 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

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Cristina Botella, Professor

  Universitat Jaume I, Castellon, Spain

  STUDY DIRECTOR

• Amanda Díaz, PhD Student

  Universitat 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: October 15, 2015
• First Posted: October 19, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: June 1, 2020
• Last Updated: June 16, 2022

Record last verified: 2022-06

Locations

ES (1)