Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384196
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-22
Brief Title:
Identity-Based Transdiagnostic Therapy for Young People With Anxiety and Depression
Sponsor:
University of Barcelona
Organization:
University of Barcelona
Study Overview
Official Title:
Identity-Based Transdiagnostic Therapy for Young People With Anxiety and Depression Engagement Efficacy and Predictors of Outcome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IBTTYOUNG
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 eg 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 andor 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 andor depression of young adults than the well-established CBT-based Unified Protocol
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 eg 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 eg 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 andor 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 andor 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 andor 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 patients personal style characteristics and preferences An optimal personalization of the treatment favors the patients 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 11 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 Students 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 womanmaleother 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 andor 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 subjects life that have been more affected by the occurring changes as well as indicators of the techniques that were perceived as more useful
General objectives
With this project the goal is to increase the efficacy of psychological therapies for anxiety andor 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 patients personal style characteristics and preferences An optimal personalization of the treatment favors the patients 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 11 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 Students 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 womanmaleother 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 andor 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 subjects life that have been more affected by the occurring changes as well as indicators of the techniques that were perceived as more useful
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None