Clinical trial NCT06547450: Unified Protocol for Treatment of Emotional Disorders in Brief Groups in Primary Care Services in Spain
Official title: Study of the Cost-efficacy and Acceptability of the Unified Protocol for Treatment of Emotional Disorders in Brief Groups in Primary Care Services in Spain (PU-AP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional Disorder
Anxiety Disorders
Depressive Disorder
Keywords: Emotional Disorder
Unified Protocol
Primary Care
Transdiagnostic approach
Group format
Brief format
Lead sponsor: Instituto de Investigación Sanitaria Aragón
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
timeFrame: Enrollment and Up to 6 months
measure: Overall Depression Severity and Impairment Scale (ODSIS)
timeFrame: Up to 6 months
measure: Overall Anxiety Severity and Impairment Scale (OASIS)
timeFrame: Up to 6 months
measure: Health-related quality of life (EuroQol-5D)
timeFrame: Up to 6 months
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Up to 6 months
Secondary outcomes:
measure: The Multidimensional Emotional Disorder Inventory (MEDI)
timeFrame: Up to 6 months
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Up to 6 months
measure: Working Alliance Inventory-Short (WAI-S)
timeFrame: Up to 6 months
measure: Maladjustment Scale (MI)
timeFrame: Up to 6 months
measure: Positive and negative affect scale
timeFrame: Up to 6 months
measure: Adaptation of Client Satisfaction Questionnaire [CSQ-8]
timeFrame: Up to 6 months
measure: Quality-adjusted Life Years (QALYs)
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Villarreal
country: Spain
facility: Centro de Salud Carinyena, Hospital Universitario de La Plana
state: Comunidad Valenciana
Study officials:
affiliation: Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza
name: Jorge Osma, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.