Identity-Based Transdiagnostic Therapy for Young People With Anxiety and Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-29
SponsorUniversity of Barcelona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Identity-Based Transdiagnostic Therapy (IBTT)
BehavioralIn 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.
Unified Protocol
BehavioralIn this study, the UP is applied in 16, one-hour weekly sessions based on contemporary cognitive and behavioral techniques.
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: Identity-Based Transdiagnostic Therapy (IBTT)Experimental treatment 1 intervention
Group B: Unified Protocol (UP)Active comparator 1 intervention
Trial outcomes
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.
Time frame
DASS-21 will be administered at baseline, at 16 weeks (at completion), and at three-month follow-up.Secondary outcomes
1
Clinical Outcomes in Routine Evaluation-Short Form B (CORE-SFB)
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.
Time frame
CORE-SFB will be administered at baseline, every session, at 16 weeks (at completion), and at three-month follow-up.2
Session Rating Scale 3.0 (SRS 3.0)
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.
Time frame
Session Rating Scale 3.0 will be administered at the end of each therapy session, during 16 weeks.3
Life Satisfaction Scale (LSS)
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.
Time frame
Life Satisfaction Scale be administered at baseline, at 16 weeks (at completion), and at three-month follow-up.4
Self-Concept Clarity Scale (SCCS)
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.
Time frame
SCCS will be administered at baseline and at 16 weeks (at completion).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Barcelona
Lead sponsor
Badalona Serveis Assistencials
Collaborator
Nou Barris Mental Health Center
Collaborator
Pere Claver Grup
Collaborator
Source ClinicalTrials.gov