Identity-Based Transdiagnostic Therapy for Young People With Anxiety and Depression (IBTTYOUNG)

January 22, 2026 updated by: Dr. Guillem Feixas, University of Barcelona

Identity-Based Transdiagnostic Therapy for Young People With Anxiety and Depression: Engagement, Efficacy, and Predictors of Outcome

Depression and anxiety are the most prevalent mental disorders among both the general population and young adults, and transdiagnostic treatments for these patients are mostly based on cognitive-behavioral therapy (CBT). Based on common (transdiagnostic) principles of treatment (e.g., emotional exposure), these approaches have proliferated and demonstrated their efficacy in comparison to disorder-specific treatments. Although there are a few transdiagnostic approaches for children and adolescents, it was not possible to not find anyone targeting young people. For this reason, the investigators proposed the Identity-Based Transdiagnostic Therapy (IBTT) as a new treatment modality ideally created to address the challenge of improving the outcomes of psychotherapy for young adults with anxiety and/or depression. The IBTT is a psychological treatment for emotional disorders specifically designed for the youths in terms of their attitudes to treatment (attractiveness, engagement), and highly personalized to their construal of self and others. This project will allow testing the hypothesis that a novel brief psychotherapeutic intervention, IBTT, will be more efficacious in the treatment of the anxiety and/or depression of young adults than the well-established CBT-based Unified Protocol.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Depression and anxiety are the most prevalent mental disorders among both the general population and young adults, and transdiagnostic treatments for these patients are mostly based on cognitive-behavioral therapy (CBT). One reason for their emergence is the observation of common psychological processes (e.g., negative affectivity) among emotional disorders that outweigh differences between specific disorders. Relatedly, in favor of a transdiagnostic approach, there is the more pragmatic argument of the high comorbidity among these disorders, making the consecutive application of specific manuals a barrier to evidence-based practice in the real world. Based on common (transdiagnostic) principles of treatment (e.g., emotional exposure), these approaches have proliferated and demonstrated their efficacy in comparison to disorder-specific treatments. The investigators propose Identity-Based Transdiagnostic Therapy (IBTT), a new treatment modality, to address the challenge of improving the outcomes of psychotherapy for young adults with anxiety and/or depression. IBTT is a psychological treatment for emotional disorders specifically designed for the youths in terms of their attitudes to treatment (attractiveness, engagement), by enhancing current constructivist psychotherapy practice with Explore Your Meanings (EYME), a technological platform including Virtual Reality (VR), to enable the immersive exploration of the participants self-identity. This project will allow testing the hypothesis that a novel brief psychotherapeutic intervention, IBTT, will be more efficacious in the treatment of the anxiety and/or depression of young adults than the well-established CBT-based Unified Protocol.

General objectives

With this project, the goal is to increase the efficacy of psychological therapies for anxiety and/or depression in young adults. That is, aiming to obtain better clinical results with IBTT, a promissory and novel treatment modality, than with the Unified Protocol, which is based on CBT and considered the most efficacious transdiagnostic treatment for emotional disorders. By obtaining supporting evidence for IBTT, the range of psychotherapeutic alternatives for these emotional disorders will be increased. This will benefit the potential for adapting the interventions to each patient's personal style, characteristics, and preferences. An optimal personalization of the treatment favors the patient's engagement in therapy and strengthens the therapeutic alliance, which, in turn, should be reflected in the facilitation of the change process.

Specific objectives

  1. To assess the efficacy of an innovative VR-enhanced treatment modality of psychotherapy (IBTT) which has never been tested before. Differential outcomes will be considered not only in terms of statistical but also clinical significance, drop-out, and remission rates. In addition to the reduction of anxiety and depressive symptoms, our study is aimed at bettering psychological functioning, self-concept clarity, self-esteem, metacognitive mastery, well-being, and satisfaction with the services provided.
  2. To identify baseline variables predicting outcome, including sociodemographic and clinical variables as well as characteristics of the personal construct system such as the level of cognitive conflict.
  3. To gauge the significance of the therapeutic alliance in the two treatment modalities of the study, and its influence on the therapeutic outcomes.
  4. To explore the personal views of participants concerning the therapy process that they will have experienced, as a way to advance our knowledge of the therapy process (including the incorporation of VR into that process) and of the potential adverse effects of each treatment. To compare this knowledge with the quantitative results of the study might be helpful for a better understanding of the entire process.
  5. To analyze the gender-specific effects of the two treatments so that we can better adapt future applications of these treatments according to gender variables.
  6. To disseminate the results of the project: the study protocol, therapy outcomes, the IBTT therapy manual, and the qualitative aspects.

Procedure

The project will be presented to clinical professionals of the centers participating in the study to stimulate the recruitment of participants according to the eligibility criteria. Referring professionals will provide a link (or QR) to participants interested in the study. Participants will find a welcome message with an explanation of the purpose and characteristics of the study and the option to provide informed consent to participate (including permission for the audio recording of the sessions). For those people who agree to participate, the online platform will ask to complete the sociodemographic data form, DASS-21, CORE-SFB, SCCS, RSES, MSAS-D, and LSS). After completion, an online meeting using a secure platform (Microsoft Teams) will be arranged for a clinical interview based on ICD-11 for diagnostic evaluation conducted by psychology graduates contracted by the project and trained for that purpose by researchers of the team. Participants meeting the inclusion criteria and not meeting any of the exclusion criteria will be randomly assigned to one of the two treatments of the study (1:1 ratio). Once the participant has completed the treatment (maximum 16 sessions), the end-of-therapy assessment will be conducted using DASS-21, CORE-SFB, SCCS, RSES, MSAS-D, and LSS. Then, a new online meeting will be arranged to administer the diagnostic interview and the Change Interview. It will be performed by the same evaluators who carried out the baseline assessment (whenever possible). A follow-up assessment including DASS-21, CORE-SFB, LSS, and CRES-4 will be conducted online three months after treatment termination.

Data analyses

Intention-to-treat analysis will be performed for the main statistical analyses. Descriptive analysis and intergroup comparisons will be performed with the Student´s T-test for quantitative variables, or the U-Mann-Whitney test for non-normally distributed data, and the Chi-square test for categorical variables. Linear mixed models will be used to analyze and compare treatment effects for the two arms. Baseline measurements, gender (coded as woman/male/other condition), and other sociodemographic and clinical variables will be entered into the model as covariates (DASS-21 as the primary outcome measure). For all the analyses, effect sizes and confidence intervals will be calculated.

Participants with comorbid conditions (eating and/or personality disorders, etc.) or taking psychotropic medication will not be excluded but they will be assessed and recorded for statistical analysis.

In addition to the statistical significance, the proportion of participants who attain clinically significant improvement on the outcome measures will be calculated and compared between treatment conditions. Clinical improvement will be calculated considering two conditions: reliable change (reliability of pre-to-post-difference score) and clinically significant change (to verify whether post-treatment scores lie in the normal or clinical range). To test the differences in frequencies between the treatment conditions, a Chi-square test will be applied.

The inclusion of CORE-SFB will permit assessment of the degree of therapeutic change with regard to psychological distress, psychosocial functioning, symptoms, and suicide risk. In addition, this application of CORE-SFB in each session will allow assessing the change experienced as a function of the number of sessions and the percentage of change session by session. Subgroup analyses by gender and other social determinants of health will be explored to check if there are significant differences in the therapy course. A secondary analysis will be performed by taking as a criterion variable satisfaction with life (LSS), as a way to assess the evolution of a positive outcome, and its relationship with the other outcomes will also be examined using correlational analysis. Other secondary analyses will examine the change that occurred in SCCS, RSES, and MSAS-D.

For the analysis of the Change Interview (used to capture the participants' subjective experience on the changes they may have experienced), the transcript of the audio recording of the interview will be used. Two independent researchers (psychology graduates) will record the mean number of changes elicited by subjects to be compared across samples, as well as the means of the following quantitative measures for each change, which are rated by respondents using a 5-point Likert scale: (1) relevance of the change experienced; (2) the extent to which the change was expected or surprising; (3) the extent to which the change was attributable to the effect of therapy. In addition, some qualitative analyses of the retrieved information will be conducted. First, two judges (psychology graduates) will independently perform content analysis, categorizing each change using the coding manual developed for this purpose. Second, another two judges (psychology graduates contracted) will also perform a similar analysis, but this time there will be no given categories, so these judges will have to make up their own. This second approach is based on the "grounded theory". This way, more information will be obtained about the areas of the subject's life that have been more affected by the occurring changes, as well as indicators of the techniques that were perceived as more useful.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Guillem Feixas, PhD
  • Phone Number: +34933125100
  • Email: gfeixas@ub.edu

Study Locations

  • Spain
      • Badalona, Spain, 08911
        • Recruiting
        • Badalona Serveis Assistencials
        • Contact:
      • Barcelona, Spain, 08042
        • Recruiting
        • Associació Centre Higiene Mental Nou Barris
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Participants with symptoms of depression and/or anxiety as their primary complaint.

Exclusion Criteria:

  • Participants with post-traumatic stress, bipolar and substance use disorders, psychotic symptoms, organic brain dysfunction, marked suicidal ideation and/or intellectual disability.
  • Participants receiving psychological treatment, unless it is suspended at the time of inclusion in the study itself in agreement with their therapist.
  • Participants for whom the use of virtual reality may pose a risk, even a minor risk (epilepsia, acute otorhinolaryngological processes or recent interventions, severe cardiovascular disease, unstable hypertension, and pregnancy).
  • Participants with substantial visual, hearing, and cognitive deficits.
  • Participants who do not have enough competence to communicate in Spanish or Catalan.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Identity-Based Transdiagnostic Therapy (IBTT)
IBTT is based on Personal Construct Therapy enhanced with Virtual Reality. In this version, psychotherapy focuses on identity conflicts and processes using an immersive exploration of self and others. After some observational evidence, this is the first study to test the efficacy of this innovative approach rigorously.
Behavioral: Identity-Based Transdiagnostic Therapy (IBTT)
In this study, IBTT is applied in 16, one-hour weekly sessions based on contemporary constructivist psychotherapy enhanced with the technological platform EYME-Explore Your Meanings to enable the immersive exploration of the patient's self-identity. Although it could be applied to other populations, IBTT has been designed to improve the mental health of late adolescents and young people.
Active Comparator: Unified Protocol (UP)
The UP is a transdiagnostic psychotherapy for anxiety and/or depression based on Cognitive-Behavioral Therapy (CBT). Several previous studies provide substantive evidence for the efficacy of the UP for these disorders.
Behavioral: Unified Protocol
In this study, the UP is applied in 16, one-hour weekly sessions based on contemporary cognitive and behavioral techniques.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Depression, Anxiety and Stress Scales (DASS-21)
Time Frame: DASS-21 will be administered at baseline, at 16 weeks (at completion), and at three-month follow-up.
This 21-item version of the DASS comprises 7 items for its three scales (depression, anxiety, and stress) which are moderately correlated with each other. Respondents are asked to rate each item on a four-point Likert scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time) considering the past week.The scores for each scale range from 0 to 21 and the total score of the DASS-21 (0-63) is the primary outcome measure of the study. Higher scores in each scale indicate higher levels of depression, anxiety and stress, respectively.
DASS-21 will be administered at baseline, at 16 weeks (at completion), and at three-month follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical Outcomes in Routine Evaluation-Short Form B (CORE-SFB)
Time Frame: CORE-SFB will be administered at baseline, every session, at 16 weeks (at completion), and at three-month follow-up.
CORE-SFB comprises 18 items (a short version of the 34-item self-report questionnaire CORE-OM) distributed across four scales assessing subjective well-being, symptoms or problems, life functioning, and risk. Respondents are asked to consider the past week and rate each item on a five-point Likert scale ranging from 0 (not at all) to 4 (most or all the time). Scores range between 0 and 72. Higher scores indicate worse outcome.
CORE-SFB will be administered at baseline, every session, at 16 weeks (at completion), and at three-month follow-up.
Session Rating Scale 3.0 (SRS 3.0)
Time Frame: Session Rating Scale 3.0 will be administered at the end of each therapy session, during 16 weeks.
Session Rating Scale is a brief questionnaire designed to assess therapeutic alliance at the end of the session. It is composed of 4 items that have to be answered through a Visual Analog Scale (VAS) of 10 centimetres, and scores range between 0-40. Higher scores indicate greater appreciation of the relationship with the therapist, agreement with the therapist about the goals and issues discussed in the session, agreement with the therapist's method or approach, and global assessment of the session.
Session Rating Scale 3.0 will be administered at the end of each therapy session, during 16 weeks.
Life Satisfaction Scale (LSS)
Time Frame: Life Satisfaction Scale be administered at baseline, at 16 weeks (at completion), and at three-month follow-up.
Life Satisfaction Scale is a single-item scale using a Likert scale of 10 points to capture the respondent's overall degree of satisfaction with life at the present moment. Scale ranging between 1 and 10. Higher scores indicate greater satisfaction.
Life Satisfaction Scale be administered at baseline, at 16 weeks (at completion), and at three-month follow-up.
Self-Concept Clarity Scale (SCCS)
Time Frame: SCCS will be administered at baseline and at 16 weeks (at completion).
This version of the Self-Concept Clarity Scale consists of 12 items for assessing the level of clarity of the self-concept using a five-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores ranging between 12 and 60. Higher scores indicate stronger self-concept clarity.
SCCS will be administered at baseline and at 16 weeks (at completion).
Rosenberg Self-Esteem Scale (RSES)
Time Frame: Rosenberg Self-Esteem Scale will be administered at baseline and at 16 weeks (at completion).
Rosenberg Self-Esteem Scale is a self-report instrument to measure global self-esteem and consists of 10 items using a four-item Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree). Scores ranging between 10 and 40. Higher scores indicate greater self-judgment of value, confidence, and competence.
Rosenberg Self-Esteem Scale will be administered at baseline and at 16 weeks (at completion).
Metacognition Self-Assessment Scale, Subscale D (MSAS-5)
Time Frame: Metacognition Self-Assessment Scale (subscale D) will be administered at baseline and at 16 weeks (at completion).
Metacognition Self-Assessment Scale (MSAS) is an 18-item self-report measure, answered on a five-point Likert scale (1 = never, 5 = always), range of 18-90 points, where higher scores indicate higher metacognitive performance. In this study, only the 5 items of the scale D of the MSAS. Scale D scores range of 5-25 points. Higher scores indicate greater metacognitive mastery, related to self-regulation and control activities.
Metacognition Self-Assessment Scale (subscale D) will be administered at baseline and at 16 weeks (at completion).
Problem definition form
Time Frame: This form will be administered at baseline.
This is a brief-structured interview aimed to define the problem (or the problems) the person is experiencing, its relevance, and the levels of distress it causes.
This form will be administered at baseline.
Change Interview
Time Frame: This form will be administered at 16 week (at completion)
This semi-structured interview was created to assess the changes produced throughout therapy, the useful aspects, and the adverse effects of interventions from the patient's perspective.
This form will be administered at 16 week (at completion)
Consumer Reports Effectiveness Scale (CRES-4)
Time Frame: Consumer Reports Effectiveness Scale only will be administered at three-month follow-up.
To interpret Consumer Reports Effectiveness Scale-4, a score is considered that is on a scale ranging from 0 to 5 points. The higher the total score, the greater the satisfaction with the treatment according to the patient.
Consumer Reports Effectiveness Scale only will be administered at three-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Barcelona

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nou Barris Mental Health Center
Badalona Serveis Assistencials

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillem Feixas, PhD, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PID2022-138902OB-I00

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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