Identity-Based Transdiagnostic Therapy for Young People With Anxiety and Depression: Engagement, Efficacy, and Predictors of Outcome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Depression, Anxiety and Stress Scales (DASS-21)
研究概览
简要总结
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.
详细描述
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
- 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.
- 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.
- To gauge the significance of the therapeutic alliance in the two treatment modalities of the study, and its influence on the therapeutic outcomes.
- 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.
- 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.
- To disseminate the results of the project: the study protocol, therapy outcomes, the IBTT therapy manual, and the qualitative aspects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 16 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with symptoms of depression and/or anxiety as their primary complaint.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Unified Protocol (Behavioral)
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.
干预措施: Identity-Based Transdiagnostic Therapy (IBTT) (Behavioral)
结局指标
主要结局
Depression, Anxiety and Stress Scales (DASS-21)
时间窗: 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.
次要结局
- Rosenberg Self-Esteem Scale (RSES)(Rosenberg Self-Esteem Scale will be administered at baseline and at 16 weeks (at completion).)
- Metacognition Self-Assessment Scale, Subscale D (MSAS-5)(Metacognition Self-Assessment Scale (subscale D) will be administered at baseline and at 16 weeks (at completion).)
- Self-Concept Clarity Scale (SCCS)(SCCS will be administered at baseline and at 16 weeks (at completion).)
- Problem definition form(This form will be administered at baseline.)
- Change Interview(This form will be administered at 16 week (at completion))
- Consumer Reports Effectiveness Scale (CRES-4)(Consumer Reports Effectiveness Scale only will be administered 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.)
- 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.)
- Life Satisfaction Scale (LSS)(Life Satisfaction Scale be administered at baseline, at 16 weeks (at completion), and at three-month follow-up.)
研究者
Dr. Guillem Feixas
Full Professor
University of Barcelona