Emotional DisorderNCT04304911
UP in Blended Format for Transdiagnostic Treatment of Emotional Disorders in the Spanish National Health System
A study testing Blended intervention (UP-APP) and Cognitive Behavioral Therapy (TAU) in people with Emotional Disorder and Anxiety Disorders, run by Instituto de Investigación Sanitaria Aragón at 1 site in Spain.
Trial summary
The present randomized, controlled trial will compare the efficacy, cost-effectiveness, and implementation characteristics of a blended intervention based on the Unified Protocol (UP) for transdiagnostic treatment of emotional disorders against the treatment as usual in a sample of patients with emotional disorders in… 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?
- Blended intervention (UP-APP) and Cognitive Behavioral Therapy (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Principal diagnosis of Emotional disorder (Evaluated by MINI interview)
- The patient is over 18 years of age
- The patient is fluent in the language in which the therapy is performed (Spanish in the present study)
- To have a Smartphone
- Patients taking pharmacological treatment for their ED will be asked to maintain the same dosages and medications for at least 3 months prior to enrolling in the study and during the whole treatment
- The patient signs the informed consent form.
Who cannot join
- The patient presents a severe condition that would require to be prioritized for treatment, these include a severe mental disorder (bipolar disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance use in the last three months
- The patient has previously received 8 or more sessions of psychological treatment with clear and identifiable Cognitive behavioral therapy (CBT) principles within the past 5 years.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Comarcal de Vinaròs
Vinaròs, Valencia, 12500
Vanessa
About this study
Official title: Implementation, Effficacy and Cost-effective Study of the Unified Protocol in Blended Format for Transdiagnostic Treatment of Emotional Disorders in the Spanish National Health System
The present randomized, controlled trial will compare the efficacy, cost-effectiveness, and implementation characteristics of a blended intervention based on the Unified Protocol (UP) for transdiagnostic treatment of emotional disorders against the treatment as usual in a sample of patients with emotional disorders in the Spanish National 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. Due to the excessive demand for treatment, mental health services of our National Health System (NHS) are collapsed with large waiting lists, which results in a great difficulty to dedicate the recommended time to attend patients who require psychological treatment. Therefore, it is needed to find solutions for the effective and cost-effective treatment of EDs in our NHS. In the last years, several solutions have been proposed to alleviate this important health problem.
The general objective of this project is to contribute to the dissemination of evidence-based psychological treatments in our Public National Health System for the most prevalent mental disorders in our society, emotional disorders (EDs). The investigators will study the efficacy, cost-effectiveness, and implementation characteristics (acceptability, usability, and utility) of a blended intervention which will enhance face-to-face treatment by incorporating an app-based intervention onsite treatment. Based on the most recent clinical advances in the treatment of EDs, the investigators will use the Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP). The investigators hypothesize that the blended intervention will be superior to the treatment as usual (face-to-face, specific-disorder treatment) because patients in the UP-APP condition will continue working with the app at home between sessions. In sum, this project is composed of three connected studies: a validation study in a clinical sample of patients with EDs, two pilot studies to help develop the app based on the UP principles, and a multicenter, randomized and controlled clinical trial that will be conducted by 12 clinical psychologist working in 8 different provinces in Spain.
- Conditions
- Emotional Disorder, Anxiety Disorders, Depressive Disorder
- Being tested
- Blended intervention (UP-APP), Cognitive Behavioral Therapy (TAU)
- Keywords
- Emotional Disorder, Unified Protocol, Public health, Transdiagnostic approach
- 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.
Blended intervention (UP-APP)Behavioural
Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP)
Cognitive Behavioral Therapy (TAU)Behavioural
TAU group that carries out Cognitive Behavioral Therapy in an individual format
| Study group | Role | What they receive |
|---|---|---|
| UP in blended format | Experimental | Clinicians will follow the UP therapist manual, 2nd edition, recently translated by Osma and Crespo (13,14). The same contents through a digital material (video and audio) will be integrated in the UP-APP. The program can be developed in a range of 12 to 16 sessions. The UP includes 8 modules Receives: Behavioral: Blended intervention (UP-APP) |
| Treatment as usual (TAU) | Active comparator | Cognitive Behavioral Therapy in individual format is the treatment of choice (TAU) by psychologists and psychiatrists at the collaborating Public Mental Health Centers and Primary Care Centers, together with pharmacological treatment (i.e., antidepressants and / or anxiolytics). Receives: Behavioral: Cognitive Behavioral Therapy (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 12 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 12 months
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Diagnostic interview
Measured: Enrolment and Up to 12 months
Secondary outcomes (14)
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
Measured: Up to 12 months
Health-related quality of life (EuroQol-5D)
Evaluation through 5 items of quality of life.
Measured: Up to 12 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 and the experience of participating in a blended format.
Measured: Up to 12 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 12 months
Emotion Regulation Questionnaire (ERQ)
Consists of 10 items covering two factors: Cognitive Reappraisal (six items) and Expressive Suppression (four items). Items are rated on a 7-point Likert scale ranging from ''Strongly disagree'' to ''Strongly agree'
Measured: Up to 12 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 12 months
Credibility/Expectancy Questionnaire (CEQ)
The CEQ consists of six items scored on a scale of 1 to 9 and measures treatment expectancy and credibility of justification for use in clinical outcome studies.
Measured: Up to 12 months
System Usability Scale (SUS)
Composed of 10 statements that are scored on a 5-point scale of strength of agreement [0-100]
Measured: Up to 12 months
Client Service Receipt Inventory (CSRI)
Evaluate the emergency service (total visits), general medical inpatient hospital admissions (total days); outpatient health care services (total visits to general practitioner, nurse, social worker, psychologist, and other community health care professionals).
Measured: Up to 12 months
Working Alliance Inventory-Short (WAI-S)
Evaluate the therapeutic or working alliance
Measured: During psychological treatment
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 12 months
UP-APP outcomes
Number and time of use of the UP-APP, videos viewed and exercises completed
Measured: During psychological treatment
Evaluation of the UP-APP
16 items that evaluate the opinion about the app's aesthetics, handling and components
Measured: Up to 12 months
Evaluation questionnaire of the Unified Protocol (UP) modules
Consists of 7 items that evaluate the usefulness of the program to improve emotional regulation and the usefulness of each of the skills that are worked on in the different UP modules
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start1 Mar 2023
- Primary completionMar 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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: Treatment as Usual (TAU) or UP-APP. 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 UP-APP or to TAU.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria Aragón
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Osma, Ph.D, Principal investigator, Instituto de Investigación Sanitaria de Aragón, Universidad de Zaragoza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304911
- Sponsor's protocol ID
- IPES/PI20/00697
- Status last verified
- Sep 2023
- First submitted
- 9 Mar 2020
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Under request
Publications
Martinez-Garcia L, Schaeuffele C, Peris-Baquero O, Torres Alfosea MA, Osma J. Acceptability and preliminary effectiveness of the Unified Protocol in blended format in the Spanish public mental health system: Results from a Pilot Randomized Controlled Trial. Psychother Res. 2026 Jun;36(5):987-1004. doi: 10.1080/10503307.2025.2541707. Epub 2025 Aug 12.
PubMed 40792553Osma J, Martinez-Garcia L, Peris-Baquero O, Navarro-Haro MV, Gonzalez-Perez A, Suso-Ribera C. Implementation, efficacy and cost effectiveness of the unified protocol in a blended format for the transdiagnostic treatment of emotional disorders: a study protocol for a multicentre, randomised, superiority controlled trial in the Spanish National Health System. BMJ Open. 2021 Dec 31;11(12):e054286. doi: 10.1136/bmjopen-2021-054286.
PubMed 34972770
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation, Effficacy and Cost-effective Study of the Unified Protocol in Blended Format for Transdiagnostic Treatment of Emotional Disorders in the Spanish National Health System
- ClinicalTrials.gov ID
- NCT04304911
- Acronym / sponsor ID
- IPES/PI20/00697
- Conditions
- Emotional Disorder, Anxiety Disorders, Depressive Disorder
- Keywords
- Emotional Disorder, Unified Protocol, Public health, Transdiagnostic approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria AragónUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 12 Mar 2020 (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 present randomized, controlled trial will compare the efficacy, cost-effectiveness, and implementation characteristics of a blended intervention based on the Unified Protocol (UP) for transdiagnostic treatment of emotional disorders against the treatment as usual in a sample of patients with emotional disorders in the Spanish National 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. Due to the excessive demand for treatment, mental health services of our National Health System (NHS) are collapsed with large waiting lists, which results in a great difficulty to dedicate the recommended time to attend patients who require psychological treatment. Therefore, it is needed to find solutions for the effective and cost-effective treatment of EDs in our NHS. In the last years, several solutions have been proposed to alleviate this important health problem.
The general objective of this project is to contribute to the dissemination of evidence-based psychological treatments in our Public National Health System for the most prevalent mental disorders in our society, emotional disorders (EDs). The investigators will study the efficacy, cost-effectiveness, and implementation characteristics (acceptability, usability, and utility) of a blended intervention which will enhance face-to-face treatment by incorporating an app-based intervention onsite treatment. Based on the most recent clinical advances in the treatment of EDs, the investigators will use the Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP). The investigators hypothesize that the blended intervention will be superior to the treatment as usual (face-to-face, specific-disorder treatment) because patients in the UP-APP condition will continue working with the app at home between sessions. In sum, this project is composed of three connected studies: a validation study in a clinical sample of patients with EDs, two pilot studies to help develop the app based on the UP principles, and a multicenter, randomized and controlled clinical trial that will be conducted by 12 clinical psychologist working in 8 different provinces in Spain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- 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: Treatment as Usual (TAU) or UP-APP. 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 UP-APP or to TAU.
| Arm | Type | Receives |
|---|---|---|
| UP in blended format | Experimental | Behavioral: Blended intervention (UP-APP)Clinicians will follow the UP therapist manual, 2nd edition, recently translated by Osma and Crespo (13,14). The same contents through a digital material (video and audio) will be integrated in the UP-APP. The program can be developed in a range of 12 to 16 sessions. The UP includes 8 modules |
| Treatment as usual (TAU) | Active comparator | Behavioral: Cognitive Behavioral Therapy (TAU)Cognitive Behavioral Therapy in individual format is the treatment of choice (TAU) by psychologists and psychiatrists at the collaborating Public Mental Health Centers and Primary Care Centers, together with pharmacological treatment (i.e., antidepressants and / or anxiolytics). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Principal diagnosis of Emotional disorder (Evaluated by MINI interview)
- The patient is over 18 years of age
- The patient is fluent in the language in which the therapy is performed (Spanish in the present study)
- To have a Smartphone
- Patients taking pharmacological treatment for their ED will be asked to maintain the same dosages and medications for at least 3 months prior to enrolling in the study and during the whole treatment
Key exclusion criteria (2 listed)
- The patient presents a severe condition that would require to be prioritized for treatment, these include a severe mental disorder (bipolar disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance use in the last three months
- The patient has previously received 8 or more sessions of psychological treatment with clear and identifiable Cognitive behavioral therapy (CBT) principles within the past 5 years.
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 |
|---|---|---|
| Blended intervention (UP-APP)Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP) | Behavioural | UP in blended format |
| Cognitive Behavioral Therapy (TAU)TAU group that carries out Cognitive Behavioral Therapy in an individual format | Behavioural | Treatment as usual (TAU) |
Primary outcome
Overall Depression Severity and Impairment Scale (ODSIS)
Time frame: Up to 12 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 12 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).
Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-V)
Time frame: Enrolment and Up to 12 months
Diagnostic interview
14 secondary outcomes
The Multidimensional Emotional Disorder Inventory (MEDI)
Time frame: Up to 12 months
Health-related quality of life (EuroQol-5D)
Time frame: Up to 12 months
Adaptation of Client Satisfaction Questionnaire [CSQ-8]
Time frame: Up to 12 months
Five Facet Mindfulness Questionnaire (FFMQ)
Time frame: Up to 12 months
Emotion Regulation Questionnaire (ERQ)
Time frame: Up to 12 months
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Up to 12 months
Credibility/Expectancy Questionnaire (CEQ)
Time frame: Up to 12 months
System Usability Scale (SUS)
Time frame: Up to 12 months
Client Service Receipt Inventory (CSRI)
Time frame: Up to 12 months
Working Alliance Inventory-Short (WAI-S)
Time frame: During psychological treatment
Quality-adjusted Life Years (QALYs)
Time frame: Up to 12 months
UP-APP outcomes
Time frame: During psychological treatment
Evaluation of the UP-APP
Time frame: Up to 12 months
Evaluation questionnaire of the Unified Protocol (UP) modules
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Derived from this study: PubMed 40792553Martinez-Garcia L, Schaeuffele C, Peris-Baquero O, Torres Alfosea MA, Osma J. Acceptability and preliminary effectiveness of the Unified Protocol in blended format in the Spanish public mental health system: Results from a Pilot Randomized Controlled Trial. Psychother Res. 2026 Jun;36(5):987-1004. doi: 10.1080/10503307.2025.2541707. Epub 2025 Aug 12.
- Derived from this study: PubMed 34972770Osma J, Martinez-Garcia L, Peris-Baquero O, Navarro-Haro MV, Gonzalez-Perez A, Suso-Ribera C. Implementation, efficacy and cost effectiveness of the unified protocol in a blended format for the transdiagnostic treatment of emotional disorders: a study protocol for a multicentre, randomised, superiority controlled trial in the Spanish National Health System. BMJ Open. 2021 Dec 31;11(12):e054286. doi: 10.1136/bmjopen-2021-054286.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink 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. This study is not recruiting at the moment.
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 Blended intervention (UP-APP) and Cognitive Behavioral Therapy (TAU) 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Sep 2023. 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?
Results are not available in the source record.
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?
Overall Depression Severity and Impairment Scale (ODSIS) (time frame: Up to 12 months). The study lists 3 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 NCT04304911, which also lists 2 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 25 Sep 2023.