Unified Protocol for Treatment of Emotional Disorders in Brief Groups in Primary Care Services in Spain

NCT06547450 | Not Yet Recruiting

• 1 other identifier: PID2023-151473OB-100
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to contribute to the improvement of psychological care received in primary care (PC), through the study of the cost-effectiveness and acceptability of the Unified Protocol for the treatment of emotional disorders in brief groups in primary care services in Spain (PU-AP) for the treatment of emotional disorders (EDs), the most prevalent in our society. To do so, a pilot study will be carried out, and, subsequently, a randomized clinical trial to study the efficacy, cost-effectiveness and acceptability of the Unified Protocol for the transdiagnostic treatment of EDs, applied in 5 or 8 group sessions. Finally, the researchers will analyze whether there are specific patient profiles that will benefit more from one or the other condition. The results will contribute to the personalization of the psychological treatment of users with EDs attending PC in the Spanish public health system.

Conditions

Emotional Disorder; Anxiety Disorders; Depressive Disorder

Keywords

Emotional Disorder; Unified Protocol; Primary Care; Transdiagnostic approach; Group format; Brief format

Outcome Measures

Primary Outcomes (5)

• Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)

  Diagnostic interview Diagnostic interview

  Enrollment and Up to 6 months

• Overall Depression Severity and Impairment Scale (ODSIS)

  Consist of five items that evaluate the frequency and the intensity of depressive symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4.

  Up to 6 months

• Overall Anxiety Severity and Impairment Scale (OASIS)

  The scale presents five items. These items are related with the frequency and intensity of anxiety symptoms and their interference with the person's work or school life and with social life. All items are rated on a 5-point Likert scale ranging from 0 (I didn't feel anxious) to 4 (Constant anxiety).

  Up to 6 months

• Health-related quality of life (EuroQol-5D)

  Evaluation through 5 items of quality of life. For this study, the visual analog scale (EQ-VAS) was used, using a score from 0 to 100 (0 = worst imaginable state of health; 100 = best imaginable state of health).

  Up to 6 months

• Difficulties in Emotion Regulation Scale (DERS)

  Consists of 36-item of six facets of emotion regulation. Items are rated on a scale of 1 ("almost never \[0-10%\]") to 5 ("almost always \[91-100%\]"). Higher scores indicate more difficulty in emotion regulation

  Up to 6 months

Secondary Outcomes (7)

• The Multidimensional Emotional Disorder Inventory (MEDI)

  Up to 6 months

• Five Facet Mindfulness Questionnaire (FFMQ)

  Up to 6 months

• Working Alliance Inventory-Short (WAI-S)

  Up to 6 months

• Maladjustment Scale (MI)

  Up to 6 months

• Positive and negative affect scale

  Up to 6 months

Study Arms (2)

5-session UP condition

EXPERIMENTAL

In both conditions, the contents of the UP manual were worked following the 2nd edition of the UP manual (Barlow et al., 2018). In the 5-session version, modules 1 (Motivation for change and commitment to treatment) and 8 (Achievement, maintenance, and relapse prevention) were removed and modules 6 and 7 (interoceptive and emotional exposure) were combined. The sessions were group sessions, 2 hours long and weekly.

Behavioral: 5-session UP condition

8-session UP condition

ACTIVE COMPARATOR

In both conditions, the contents of the UP manual were worked following the 2nd edition of the UP manual (Barlow et al., 2018). In the 8-session UP condition, each of the original 8 treatment modules was worked on per week. The sessions were group sessions, 2 hours long and weekly.

Behavioral: 8-session UP condition

Interventions

5-session UP condition BEHAVIORAL

Unified Protocol (UP) for transdiagnostic treatment of EDs in 5-session

5-session UP condition

8-session UP condition BEHAVIORAL

Unified Protocol (UP) for transdiagnostic treatment of EDs in 8-session

8-session UP condition

Eligibility Criteria

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

You may qualify if:

• Have at least one EDs diagnosis (anxiety, depressive, obsessive-compulsive, trauma and somatic disorders) from the ADIS-5 interview
• Have a score between 0 and 5 severity (mild-moderate) on the diagnoses on the CSR of the ADIS-5
• Be able to attend all assessment and treatment sessions
• Individuals on pharmacological treatment will be asked to maintain the dosage for the duration of the study, unless there is a medical contraindication

You may not qualify if:

• Absence of clinical diagnosis
• Presenting a diagnosis of EDs with a severity score on diagnoses between 6 and 8 on the ADIS-5 CSR (severe) or a clinical condition requiring specialized mental health intervention such as presence of severe mental disorder (e.g., personality disorder, bipolar disorder, or schizophrenia), suicide risk at the time of assessment, or substance use in the past three months
• Who have received 8 or more sessions of CBT (during the past five years) with techniques such as cognitive flexibility or exposure
• Who are receiving psychological treatment.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

Centro de Salud Carinyena, Hospital Universitario de La Plana

Villarreal, Valencia, 12540, Spain

Location

Related Publications (2)

• Barlow DH, Harris BA, Eustis EH, Farchione TJ. The unified protocol for transdiagnostic treatment of emotional disorders. World Psychiatry. 2020 Jun;19(2):245-246. doi: 10.1002/wps.20748. No abstract available.

  PMID: 32394551 BACKGROUND

• Peris-Baquero O, Fadrique-Jimenez A, Prieto-Rollan I, Camacho-Guerrero L, Martinez-Lluesma S, Osma J. Brief Versions of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Spanish Primary Care Service: Results of a Feasibility Pilot Study. J Clin Psychol. 2025 Nov;81(11):1103-1117. doi: 10.1002/jclp.70016. Epub 2025 Jul 16.

  PMID: 40667676 DERIVED

Related Links

• Related Info
• Related Info
• Related Info
• Related Info
• IPES web (Investigation group)

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Study Officials

• Jorge Osma, Ph.D

  Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Osma, Ph.D

CONTACT

978645390; osma@unizar.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Patients (participants) will know the treatment they have been assigned to. Healthcare professionals and researchers will know the condition each patient has been assigned to (mandatory to provide a given type of intervention).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All consecutive patients with emotional disorders attending any of the collaborating centers will be asked to participate in the present study. Once inclusion criteria are met, each patient will be randomly assigned to one of the two experimental groups: the 8-session UP group or the 5-session UP group. Randomization will be performed by a researcher unrelated to the study using a computer-generated sequence (Randomizer). Randomization will be stratified according to the severity of the primary measures of depression and anxiety, using the recommended cutoff in the manuals. Stratification will be made to ensure a comparable proportion of severely depressed and anxious individuals in each group. For each subgroup (i.e., severe or less severe depression and/or anxiety), participants will be randomly assigned to the 8-session UP group or the 5-session UP group.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: May 10, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 3, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)