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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Emotional Disorder
- Sponsor
- Instituto de Investigación Sanitaria Aragón
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
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).
Investigators
Jorge Javier Osma López
Principal Investigator
Instituto de Investigación Sanitaria Aragón
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.
Outcomes
Primary Outcomes
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Time Frame: Enrollment and Up to 6 months
Diagnostic interview Diagnostic interview
Overall Anxiety Severity and Impairment Scale (OASIS)
Time Frame: Up to 6 months
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).
Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Up to 6 months
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
Overall Depression Severity and Impairment Scale (ODSIS)
Time Frame: Up to 6 months
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.
Health-related quality of life (EuroQol-5D)
Time Frame: Up to 6 months
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).
Secondary Outcomes
- Working Alliance Inventory-Short (WAI-S)(Up to 6 months)
- Maladjustment Scale (MI)(Up to 6 months)
- Quality-adjusted Life Years (QALYs)(Up to 6 months)
- Five Facet Mindfulness Questionnaire (FFMQ)(Up to 6 months)
- Positive and negative affect scale(Up to 6 months)
- The Multidimensional Emotional Disorder Inventory (MEDI)(Up to 6 months)
- Adaptation of Client Satisfaction Questionnaire [CSQ-8](Up to 6 months)