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

Instituto de Investigación Sanitaria Aragón

Status: Not yet enrolling

Conditions: Emotional Disorder; Anxiety Disorders; Depressive Disorder

Treatments: Behavioral: 5-session UP condition; Behavioral: 8-session UP condition

Study type: Interventional

Funder types: Other

Identifiers

NCT06547450

PID2023-151473OB-100

Details and patient eligibility

About

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.

Full description

Emotional disorders (EDs;including anxiety disorders, unipolar mood disorders, and related disorders) are the most prevalent mental disorders in the general population. In Spain, anxiety disorders and mood disorders affect approximately two million (4.1%) and two and half million (5.2%) individuals, respectively. As a result of their prevalence in the society, EDs have become an alarming health problem due to their associate costs. These disorders have a direct cost of 22.000 million euros (500 euros per capita and year). The total expense of these disorders entails 2.2% of the Gross Domestic Product in Spain.

In recent years, several alternatives have been proposed to address this situation, one of them being an increase in the number of clinical psychologists in our national health system (NHS) and, especially, their incorporation into primary care (PC) services.

It is considered that the incorporation of psychology in PC will help to reduce referral to specialized care because it will be possible to carry out a more exhaustive screening and determine which cases do not require psychological treatment, which cases should be referred to other health care resources and which cases can be treated in PC, usually mild-moderate TE. Another alternative to mitigate the excessive demand for care, regardless of the level of care, is the use of group psychological interventions, a cost-effective format for systems with limited resources such as our NHS.

Transdiagnostic interventions, like the Unified Protocol for the Treatment of EDs (UP), in brief group format, has emerged as a viable option for treating EDs in PC services.

The aim of the present study is to analyze the efficacy, cost-effectiveness and acceptability of the Unified Protocol for the transdiagnostic treatment of EDs, applied in 5 or 8 group sessions.

Furthermore, it will try to find out which characteristics of the participants (e.g., gender, clinical diagnoses, transdiagnostic dimensions affected, symptom severity) predict a better outcome (e.g., clinical improvement and quality of life) as a function of the sessions received. Thus, in the future, it will be possible to offer the optimal number of sessions according to specific profiles (personalization of treatments).

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

5-session UP condition

Experimental group

Description:

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.

Treatment:

Behavioral: 5-session UP condition

8-session UP condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: 8-session UP condition