Emotional DisorderNCT06547450
Unified Protocol for Treatment of Emotional Disorders in Brief Groups in Primary Care Services in Spain
A study testing 5-session UP condition and 8-session UP condition in people with Emotional Disorder and Anxiety Disorders, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Disorder, Anxiety Disorders, Depressive Disorder
- What is being tested?
- 5-session UP condition and 8-session UP condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 10 May 2025to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Centro de Salud Carinyena, Hospital Universitario de La Plana
Villarreal, Valencia, 12540
Laura
About this study
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)
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.
Read the 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).
- Conditions
- Emotional Disorder, Anxiety Disorders, Depressive Disorder
- Being tested
- 5-session UP condition, 8-session UP condition
- Keywords
- Emotional Disorder, Unified Protocol, Primary Care, Transdiagnostic approach, Group format, Brief format
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-session UP conditionBehavioural
Unified Protocol (UP) for transdiagnostic treatment of EDs in 5-session
8-session UP conditionBehavioural
Unified Protocol (UP) for transdiagnostic treatment of EDs in 8-session
| Study group | Role | What they receive |
|---|---|---|
| 5-session UP condition | Experimental | 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. Receives: Behavioral: 5-session UP condition |
| 8-session UP condition | Active comparator | 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. Receives: Behavioral: 8-session UP condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Diagnostic interview
Diagnostic interview
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
Measured: Up to 6 months
Secondary outcomes (7)
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).
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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?
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start10 May 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Emotional DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Javier Osma López, Instituto de Investigación Sanitaria Aragón
- Investigators
- Jorge Osma, Ph.D, Principal investigator, Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547450
- Sponsor's protocol ID
- PID2023-151473OB-100
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Under request
Publications
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.
PubMed 32394551Osma J, Sanchez-Albentosa M, Prieto-Rollan I, Fadrique-Jimenez A, Navarro-Haro MV, Peris-Baquero O. Cost-effectiveness and acceptability study of the Unified Protocol for the treatment of emotional disorders in brief groups in primary care services of the Spanish National Health System: a study protocol. BMC Prim Care. 2026 May 2;27(1):243. doi: 10.1186/s12875-026-03347-w.
PubMed 42067774Peris-Baquero O, Fadrique-Jimenez A, Prieto-Rollan I, Camacho-Guerrero L, Martinez-Lluesma S, Osma J. Brief Versions of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Spanish Primary Care Service: Results of a Feasibility Pilot Study. J Clin Psychol. 2025 Nov;81(11):1103-1117. doi: 10.1002/jclp.70016. Epub 2025 Jul 16.
PubMed 40667676
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06547450
- Acronym / sponsor ID
- PID2023-151473OB-100
- Conditions
- Emotional Disorder, Anxiety Disorders, Depressive Disorder
- Keywords
- Emotional Disorder, Unified Protocol, Primary Care, Transdiagnostic approach, Group format, Brief format
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Study start
- 10 May 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 5-session UP condition | Experimental | Behavioral: 5-session UP conditionIn 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. |
| 8-session UP condition | Active comparator | Behavioral: 8-session UP conditionIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-session UP conditionUnified Protocol (UP) for transdiagnostic treatment of EDs in 5-session | Behavioural | 5-session UP condition |
| 8-session UP conditionUnified Protocol (UP) for transdiagnostic treatment of EDs in 8-session | Behavioural | 8-session UP condition |
Primary outcome
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Time frame: Enrollment and Up to 6 months
Diagnostic interview Diagnostic interview
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.
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).
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).
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
7 secondary outcomes
The Multidimensional Emotional Disorder Inventory (MEDI)
Time frame: Up to 6 months
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Up to 6 months
Working Alliance Inventory-Short (WAI-S)
Time frame: Up to 6 months
Maladjustment Scale (MI)
Time frame: Up to 6 months
Positive and negative affect scale
Time frame: Up to 6 months
Adaptation of Client Satisfaction Questionnaire [CSQ-8]
Time frame: Up to 6 months
Quality-adjusted Life Years (QALYs)
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Background: PubMed 32394551Barlow 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.
- Derived from this study: PubMed 42067774Osma J, Sanchez-Albentosa M, Prieto-Rollan I, Fadrique-Jimenez A, Navarro-Haro MV, Peris-Baquero O. Cost-effectiveness and acceptability study of the Unified Protocol for the treatment of emotional disorders in brief groups in primary care services of the Spanish National Health System: a study protocol. BMC Prim Care. 2026 May 2;27(1):243. doi: 10.1186/s12875-026-03347-w.
- Derived from this study: PubMed 40667676Peris-Baquero O, Fadrique-Jimenez A, Prieto-Rollan I, Camacho-Guerrero L, Martinez-Lluesma S, Osma J. Brief Versions of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Spanish Primary Care Service: Results of a Feasibility Pilot Study. J Clin Psychol. 2025 Nov;81(11):1103-1117. doi: 10.1002/jclp.70016. Epub 2025 Jul 16.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- IPES web (Investigation group)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Under request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorge Osma, Ph.D principal investigator
Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-session UP condition and 8-session UP condition in people with Emotional Disorder and Anxiety Disorders, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jorge Osma, Ph.D (978645390, osma@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V) (time frame: Enrollment and Up to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06547450, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.