Unified Protocol for Treatment of Emotional Disorders in Brief Groups in Primary Care Services in Spain
NCT Number: NCT06547450
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotional Disorder|Anxiety Disorders|Depressive Disorder
Interventions: BEHAVIORAL: 5-session UP condition|BEHAVIORAL: 8-session UP condition
Sponsor: Instituto de Investigación Sanitaria Aragón
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-23
Completion Date: 2027-09-01
Locations: Centro de Salud Carinyena, Hospital Universitario de La Plana, Villarreal, Comunidad Valenciana, 12540, Spain

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.

Primary Outcome Measures: 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 Outcome Measures: 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)., Up to 6 months|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), Up to 6 months|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., Up to 6 months|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)., Up to 6 months|Positive and negative affect scale, Evaluates the dimensions of positive and negative affect, through 20 items and is rated on a 5-point scale from 1 (not at all) to 5 (very much)., Up to 6 months|Adaptation of Client Satisfaction Questionnaire [CSQ-8], An adaptation of 13 items that measures quality of the intervention and its components, discomfort experienced during treatment through the following 7 questions with a 4-point Likert-type response scale (0 = nothing; 3 =very much): 1) How would you rate the quality of the treatment program you received?; 2) Did you find the kind of psychological intervention you were looking for?; 3) If a friend or family member needed similar help, would you recommend our treatment program?; 4) Has the content you have learned helped you cope more effectively with your problems?; 5) Overall, how satisfied are you with the treatment program you received?; 6) To what extent has this treatment program caused you discomfort?; 7) If you had to seek help again, would you choose a group treatment program?, Up to 6 months|Quality-adjusted Life Years (QALYs), Measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions., Up to 6 months