Online Group Psychological Intervention for People With Emotional Disorders

NCT05275322 | Unknown

• 1 other identifier: PDE2120.21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

To Assess the Clinical Usefulness and Acceptability Level of the UP Online Group Format in Argentina as Well as Participants' Satisfaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Positive and Negative Affect Schedule

  5 weeks

• Difficulties in Emotion Regulation Scale

  5 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Behavioral: Unified Protocol

Waiting list group

NO INTERVENTION

Interventions

Unified Protocol BEHAVIORAL

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).

Treatment group

Eligibility Criteria

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

You may qualify if:

• \) 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Buenos Aires: lead

Study Sites (1)

Faculty of Psychology, University of Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Location

Related Publications (1)

• Celleri M, Cremades CF, Etchevers MJ, Garay CJ. Effectiveness of the Unified Protocol for the transdiagnostic treatment of emotional disorders in online and group format in Argentina: study protocol for a randomized controlled trial. Trials. 2023 Oct 19;24(1):678. doi: 10.1186/s13063-023-07428-4.

  PMID: 37858249 DERIVED

Central Study Contacts

Martin J Etchevers, Dr.

CONTACT

+5491150386539; metcheve@psi.uba.ar

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

AR (1)