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

NCT06384196 | Recruiting

• 1 other identifier: PID2022-138902OB-I00
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Depression; Anxiety

Keywords

Young Adult; Virtual Reality; Self-identity; Sense of identity; Psychological Conflict; Self-concept; Self-assessment; Metacognitive Awareness; Cognitive Reflection; Personal Satisfaction; Patient Satisfaction; Psychological Well-Being; Therapeutic Alliance; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• Depression, Anxiety and Stress Scales (DASS-21)

  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 Outcomes (9)

• Clinical Outcomes in Routine Evaluation-Short Form B (CORE-SFB)

  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)

  Session Rating Scale 3.0 will be administered at the end of each therapy session, during 16 weeks.

• Life Satisfaction Scale (LSS)

  Life Satisfaction Scale be administered at baseline, at 16 weeks (at completion), and at three-month follow-up.

• Self-Concept Clarity Scale (SCCS)

  SCCS will be administered at baseline and at 16 weeks (at completion).

• Rosenberg Self-Esteem Scale (RSES)

  Rosenberg Self-Esteem Scale will be administered at baseline and at 16 weeks (at completion).

Study Arms (2)

Identity-Based Transdiagnostic Therapy (IBTT)

EXPERIMENTAL

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)

Unified Protocol (UP)

ACTIVE COMPARATOR

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

Interventions

Identity-Based Transdiagnostic Therapy (IBTT) BEHAVIORAL

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.

Identity-Based Transdiagnostic Therapy (IBTT)

Unified Protocol BEHAVIORAL

In this study, the UP is applied in 16, one-hour weekly sessions based on contemporary cognitive and behavioral techniques.

Unified Protocol (UP)

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Participants with post-traumatic stress, bipolar and substance use disorders, psychotic symptoms, organic brain dysfunction, marked suicidal ideation and/or intellectual disability.
• 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.

Sponsors & Collaborators

• Badalona Serveis Assistencials: collaborator
• University of Barcelona: lead
• Nou Barris Mental Health Center: collaborator

Study Sites (2)

Badalona Serveis Assistencials

Badalona, 08911, Spain

RECRUITING

Associació Centre Higiene Mental Nou Barris

Barcelona, 08042, Spain

RECRUITING

Related Publications (14)

• Barkham, M., Shapiro, D. A., & Morrison, L. (1988). Classification of psychological problems elicited by the Personal Questionnaire technique: A coding manual. Sheffield, UK: University of Sheffield, MRC/ESRC Social and Applied Psychology Unit.

  BACKGROUND

• Campbell, J. D., Trapnell, P. D., Heine, S. J., Katz, I. M., Lavellee, L. F., y Lehman, D. R. (1996). Self-concept clarity: Measurement, personality correlates, and cultural boundaries. Journal of Personality and Social Psychology, 70, 141-156

  BACKGROUND

• Carlucci L, Saggino A, Balsamo M. On the efficacy of the unified protocol for transdiagnostic treatment of emotional disorders: A systematic review and meta-analysis. Clin Psychol Rev. 2021 Jul;87:101999. doi: 10.1016/j.cpr.2021.101999. Epub 2021 Mar 9.

  PMID: 34098412 BACKGROUND

• Duncan, B. L., Miller, S. D., Reynolds, L., Sparks, J., Claud, D., Brown, J. & Johnson, L. D. (2003). The session rating scale: Preliminary psychometric properties of a "working" alliance scale. Journal of Brief Therapy, 3(1), 3-12.

  BACKGROUND

• Elliott, R., Slatick, E. & Urman, M. (2001). Qualitative change process research on psychotherapy: Alternative strategies. A: J. Frommer & D. L. Rennie (Eds.), Qualitative psychotherapy research: Methods and methodology (pp. 69-111). Pabst Science Publishers

  BACKGROUND

• Elliott R, Wagner J, Sales CMD, Rodgers B, Alves P, Cafe MJ. Psychometrics of the Personal Questionnaire: A client-generated outcome measure. Psychol Assess. 2016 Mar;28(3):263-278. doi: 10.1037/pas0000174. Epub 2015 Jun 15.

  PMID: 26075406 BACKGROUND

• Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, Audin K. Towards a standardised brief outcome measure: psychometric properties and utility of the CORE-OM. Br J Psychiatry. 2002 Jan;180:51-60. doi: 10.1192/bjp.180.1.51.

  PMID: 11772852 BACKGROUND

• Feixas, G., Pucurull, O., Roca, C., Paz, C., García-Grau, E., & Bados, A. (2012). Escala de Satisfacción con el tratamiento recibido (CRES-4): La versión en español. Revista de Psicoterapia, 89(23), 51-58.

  BACKGROUND

• Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.

  PMID: 2002127 BACKGROUND

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 BACKGROUND

• Lucas RE, Donnellan MB. Estimating the Reliability of Single-Item Life Satisfaction Measures: Results from Four National Panel Studies. Soc Indic Res. 2012 Feb 1;105(3):323-331. doi: 10.1007/s11205-011-9783-z. Epub 2011 Jan 13.

  PMID: 23087538 BACKGROUND

• Marchette LK, Weisz JR. Practitioner Review: Empirical evolution of youth psychotherapy toward transdiagnostic approaches. J Child Psychol Psychiatry. 2017 Sep;58(9):970-984. doi: 10.1111/jcpp.12747. Epub 2017 May 26.

  PMID: 28548291 BACKGROUND

• Pedone, R., Semerari, A., Riccardi, I., Procacci, M., Nicolò, G., & Carcione, A. (2017). Development of a self-report measure of metacognition: The metacognition self-assessment scale (MSAS). Instrument description and factor structure. Clinical Neuropsychiatry, 14(3), 185-194.

  BACKGROUND

• Rosenberg, M. (1965). Society and the adolescent self-image. Princeton University Press

  BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders; Personal Satisfaction; Patient Satisfaction; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Guillem Feixas, PhD

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillem Feixas, PhD

CONTACT

+34933125100; gfeixas@ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: The main study of this project proposal is a multi-center, single-blind, parallel-group randomized clinical trial (RCT) conducted in Catalonia (Spain).

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: May 2, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 2, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

ES (2)