Online Group Psychological Intervention for People With Emotional Disorders

Online Group Psychological Intervention for People With Emotional Disorders Using the Unified Protocol

Participants will receive an online synchronous group therapy based on the Unified Protocol (UP) model for 11 subsequent weeks, with 90-minute meetings. After every session, they will be sent the chapter with the notions addressed in the session from the UP's patient manual (Barlow et al., 2011) and the scales to work with during the week.

Participants in the waiting list will complete the evaluation scales at the same time as people in the intervention group (before the intervention, in the middle, after the intervention, three months after and six months after). After this period they will receive the group therapy based on the UP.

The group admission criteria are: 1) being 18 years old or older; 2) submitting the informed consent; 3) agreeing to participate in all the scheduled sessions; 4) agreeing to have the sessions recorded (both audio and video) for oversight purposes; 5) submitting a primary diagnosis of an anxiety disorder (e.g., panic disorder; agoraphobia; social anxiety disorder; generalized anxiety disorder; unspecific anxiety disorder), unipolar depression (major depressive disorder; dysthymia), obsessive-compulsive disorder, or post-traumatic stress disorder, according to DSM criteria and disrupting individuals' daily life or causing significant discomfort.

The group exclusion criteria are: 1) comorbidity with psychotic disorders, bipolar disorder, eating disorders, borderline personality disorder, or active severe suicidal ideation, and 2) currently receiving pharmacological treatment. All candidates who are not included in the group will be informed of this decision and will be given information on places to seek treatment. Evaluations will be carried out via video calls on the Google Meet platform, using the MINI (Ferrando et al., 2000) and SCID-II (Grilo, Anez & McGlashan, 2003) diagnostic interviews.

Study Overview

• Status: Not yet recruiting
• Conditions: To Assess the Clinical Usefulness and Acceptability Level of the UP Online Group Format in Argentina as Well as Participants' Satisfaction
• Intervention / Treatment: Behavioral: Unified Protocol

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin J Etchevers, Dr.; Phone Number: +5491150386539; Email: metcheve@psi.uba.ar

Study Locations

• Argentina
  • Ciudad Autónoma De Buenos Aires
    • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
      • Faculty of Psychology, University of Buenos Aires
      • Contact: Cristian J Garay, Dr.; Phone Number: +5491159647264; Email: cristiangaray@psi.uba.ar
      • Contact: Camila F Cremades, Lic.; Phone Number: +5491136823931; Email: camilacremades@gmail.com
      • Sub-Investigator: Milagros Celleri, Lic.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1) being 18 years old or older; 2) submitting the informed consent; 3) agreeing to participate in all the scheduled sessions; 4) agreeing to have the sessions recorded (both audio and video) for oversight purposes; 5) submitting a primary diagnosis of an anxiety disorder (e.g., panic disorder; agoraphobia; social anxiety disorder; generalized anxiety disorder; unspecific anxiety disorder), unipolar depression (major depressive disorder; dysthymia), obsessive-compulsive disorder, or post-traumatic stress disorder, according to DSM criteria and disrupting individuals' daily life or causing significant discomfort.

Exclusion Criteria:

• 1) comorbidity with psychotic disorders, bipolar disorder, eating disorders, borderline personality disorder, or active severe suicidal ideation, and 2) currently receiving pharmacological treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group	Behavioral: Unified Protocol; The Unified Protocol for transdiagnostic treatment of EDs (hereinafter UP) is a transdiagnostic treatment based on emotional regulation published in 2011 by David H. Barlow et al. (Barlow et al., 2011). It consists of eight treatment modules, with five of them being central (mindfulness, cognitive flexibility, countering emotional behaviors, tolerating physical sensations, and emotional exposure).
No Intervention: Waiting list group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory II	Beck Depression Inventory II (BDI II; Beck et al, 2006; Argentine adaptation by Brenlla & Rodríguez, 2006). The BDI II is a questionnaire designed to gauge how severe people's depressive symptoms are. It includes 21 items that probe the typical symptoms of a depressive episode. Every item features 4 options, ranging from 0 (not at all) to 3 (severe, nearly unbearable), on a Likert-type scale. It was validated and adapted to Argentina's population, with an adequate internal consistency and a Cronbach alpha coefficient of .88.	5 weeks
Beck Anxiety Inventory	Beck Anxiety Inventory (BAI; Beck et al., 1988; Argentine adaptation by Vizioli & Pagano, 2020). The BAI is an inventory designed to measure the severity of anxiety symptoms. It consists of 21 items, each addressing an anxiety symptom. Every item is rated on a Likert scale answer format that goes from 0 (not at all) to 4 (it upset me very much). This instrument was validated and adapted to Argentina's setting, with a Cronbach alpha coefficient of 0.93.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Affect Schedule	Positive and Negative Affect Schedule (PANAS; Thompson, 2007; Argentine adaptation by Moriondo et al., 2012). The PANAS inventory has been designed to measure affect in a dimensional fashion (negative affect and positive affect). The short version designed by Thompson (2007) and adapted to Argentina by Moriondo et al. (2012) has been chosen. This version covers four dimensions: trait positive affect (five items), trait negative affect (five items), state positive affect (five items), and state negative affect (five items). Every item uses a Likert-type scale rating from 1 (slightly or not at all) through 5 (very much or totally). This instrument features a Cronbach alpha coefficient of .73 (Cronbach alpha coefficient of .84 for Negative Affect and .75 for Positive Affect).	5 weeks
Difficulties in Emotion Regulation Scale	Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004; Argentine adaptation by Cremades et al., 2021). This scale measures the extent to which people use several Emotional Regulation strategies. The adapted scale includes 30 self-administered items with a Likert-type five-option scale that goes from 1 (hardly ever) to 5 (almost always) and a six-factor structure, including: (1) impulse control difficulties (six items); (2) limited access to emotional regulation strategies (six items); (3) lacking emotional acceptance (six items); (4) interference in goal-oriented behaviors (four items); (5) lacking emotional awareness (three items), and (6) lacking emotional clarity (six items).	5 weeks

Collaborators and Investigators

• Sponsor: University of Buenos Aires

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): March 11, 2022
• Last Update Submitted That Met QC Criteria: March 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PDE2120.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No