Feasibility of a Group Blended Transdiagnostic CBT Protocol for Emotional Disorders

NCT04008576 | Completed DMC

• 1 other identifier: UJaumeI_Transd_Group_Blended
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to analyze the feasibility of a blended transdiagnostic group protocol for the treatment of depression and anxiety disorders (emotional disorders) in a one-group clinical trial.

Conditions

Anxiety Disorders; Depressive Disorder

Keywords

Transdiagnostic CBT; Internet-delivered CBT; Blended CBT; Group CBT; Negative affect; Positive affect

Outcome Measures

Primary Outcomes (2)

• Change in the Overall Anxiety Severity and Impairment Scale (OASIS) (Campbell-Sills et al., 2009; González-Robles et al., 2018) at pre-, post-treatment, and at 3-month follow-up.

  The OASIS is a 5-item self-report scale that evaluates the frequency and severity of anxiety symptoms, the functional impairment related to these symptoms (i.e. school, work, home, or social impairment), and behavioral avoidance. Each item instructs respondents to endorse one of five responses that best describes their experiences over the past week. Response items are coded from 0 to 4, added together to obtain a total score ranging from 0 to 20. Previous studies have shown good internal consistency (α = 0.80), test-retest reliability, and convergent and discriminant validity. The Spanish version has shown good internal consistency (α = 0.86), and convergent and discriminant validity.

  Pre-treatment, Post treatment (4 months), follow-up (7 months)

• Change in the Overall Depression Severity and Impairment Scale (ODSIS) (Bentley et al., 2014; Mira et al., 2019) at pre-, post-treatment, and at 3-month follow-up.

  The ODSIS is a brief self-reported scale with 5 items that assess the severity and functional impairment associated with depressive symptoms. Items are coded on a 5-point scale (0-4). The sum of the scores is used to obtain the total score, which can be a maximum of 20. The measure has shown excellent internal consistency (α = 0.94 in an outpatient sample, 0.92 in a community sample, and 0.91 in a student sample) and good convergent/discriminant validity. The Spanish validation has excellent internal consistency (α = 0.93), as well as convergent and discriminant validity.

  Pre-treatment, Post treatment (4 months), follow-up (7 months).

Secondary Outcomes (6)

• Change in the Positive and Negative Affect Schedule (PANAS) (Watson, Clark, & Tellegen, 1988; Sandín et al., 1999) at pre-, post-treatment, and at 3-month follow-up.

  Pre-treatment, Post treatment (4 months), follow-up (7 months).

• Change in the NEO-five factor Inventory (NEO-FFI) (Costa & McCrae, 1992; Robins, Fraley, Roberts, & Trzesniewski, 2001; Aluja, García, Rossier, & García, 2005) at pre-, post-treatment, and at 3-month follow-up.

  Pre-treatment, Post treatment (4 months), follow-up (7 months).

• Change in the Quality of Life Index (QLI) (Mezzich, Cohen, Ruiperez, Banzato, & Zapata-Vega, 2011; Mezzich et al., 2000) at pre-, post-treatment, and at 3-month follow-up.

  Pre-treatment, Post treatment (4 months), follow-up (7 months).

• Score on the Work and Social Adjustment Scale (WSAS) (Echezarraga, Calvete, & Las Hayas, 2018; Mundt, Marks, Shear, & Greist, 2002)

  Pre-treatment, Post treatment (4 months), follow-up (7 months).

• Score on the Expectations scale and the Opinion scale (adapted from Borkovec & Nau, 1972)

  Pre-treatment, post-treatment (4 months).

Study Arms (1)

Group Blended Transdiagnostic treatment

OTHER

Behavioral: Group Blended Transdiagnostic treatment

Interventions

Group Blended Transdiagnostic treatment BEHAVIORAL

The treatment combines group face-to-face and Internet-delivered psychotherapy: 7 group sessions delivered every 3 weeks plus the use of an online treatment platform between sessions. Its goal is to learn and practice adaptive regulation strategies from a mechanistically transdiagnostic approach, with a focus on both negative and positive affectivity. Each group session will focus on one of the following core components: the first group session will focus on CBT traditional strategies such as motivation for change and psychoeducation about emotions; sessions 2 to 5 will focus on strategies to down-regulate negative affect: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, and interoceptive and situation-based emotion exposure; session 6 will focus on strategies to regulate positive affect; the final session will teach relapse prevention techniques. All the treatment components are delivered in 16 online treatment modules.

Group Blended Transdiagnostic treatment

Eligibility Criteria

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

You may qualify if:

• Aged 18 years old or older
• DSM-5 diagnosis of emotional disorder (panic disorder, agoraphobia, generalized anxiety disorder, social anxiety disorder, major depressive disorder, dysthymic disorder, other specified/unspecified depressive disorder, other specified/unspecified anxiety disorder, obsessive-compulsive disorder)
• Fluent in Spanish
• Daily access to the Internet at home; email address

You may not qualify if:

• Diagnosis of a severe mental disorder (schizophrenia, bipolar disorder, substance/alcohol use disorder)
• High risk of suicide
• Receiving another psychological treatment during the study period
• Changes and/or increases in pharmacological treatment during the study period (a decrease is accepted)

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

University Jaume I

Castellon, 12071, Spain

Location

Related Publications (1)

• Diaz-Garcia A, Gonzalez-Robles A, Garcia-Palacios A, Fernandez-Felipe I, Tur C, Castilla D, Botella C. Blended transdiagnostic group CBT for emotional disorders: A feasibility trial protocol. Internet Interv. 2021 Jan 7;23:100363. doi: 10.1016/j.invent.2021.100363. eCollection 2021 Mar.

  PMID: 33520670 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Study Officials

• Alberto González-Robles, Dr

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

• Amanda Díaz-García, Dr

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 5, 2019
• Study Start: October 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available immediately following publication.
• Access Criteria: The data will be available to anyone who wishes to access them.

Locations

ES (1)