About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Parallel
Treatments tested in this trial
5-session UP condition
BehavioralUnified Protocol (UP) for transdiagnostic treatment of EDs in 5-session
8-session UP condition
BehavioralUnified Protocol (UP) for transdiagnostic treatment of EDs in 8-session
Treatment groups
Trial outcomes
Primary outcomes
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Diagnostic interview Diagnostic interview
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.
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).
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).
Secondary outcomes
The Multidimensional Emotional Disorder Inventory (MEDI)
A self-report measure that includes only 49 items and enables to quickly assess the main transdiagnostic dimensions of Emotional disorders: neurotic temperament (MEDI\_NT), positive temperament (MEDI\_PT), depressed mood (MEDI\_DM), autonomic arousal (MEDI\_AA), somatic anxiety (MEDI\_SOM), intrusive cognitions (MEDI\_IC), social concerns (MEDI\_SOC), traumatic re-experiencing (MEDI\_TRM), and avoidance (MEDI\_AVD). It uses a 9-point Likert-type response scale (0 = Does not characterize me; 8 = Totally characterizes me).
Five Facet Mindfulness Questionnaire (FFMQ)
Is a 39-item questionnaire that measures five facets of mindfulness. responses use a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true)
Working Alliance Inventory-Short (WAI-S)
Evaluate the therapeutic or working alliance through 12 items grouped in three dimensions, called task (1, 2, 10 and 12), links (3, 5, 7 and 9) and objectives (4, 6, 8 and 11) measured through a Likert-type scale with scores ranging from 1 = Never to 7 = Always.
Maladjustment Scale (MI)
Evaluates interference in different vital areas through six items with a 6-point Likert-type response scale (0 = Not at all; 5 = Extremely).
Locations
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Sponsors and contacts
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