Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04979676
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2021-07-15
Brief Title:
Changing the Course of Social Anxiety in Adolescence
Sponsor:
University of Coimbra
Organization:
University of Coimbra
Study Overview
Official Title:
Changing the Course of Social Anxiety in Adolescence What Works Why and for Whom
Status:
COMPLETED
Status Verified Date:
2024-05
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:
TeenSAD
Brief Summary:
Social anxiety often reaches its peak during adolescence and may hold a noteworthy impact both at the social and academic levels Though some adolescents easily learn to adequately cope with it others become overwhelmed by social fears and end up avoiding social events or facing them with intense suffering Adolescents with social anxiety disorder SAD seldom seek professional help and often become adults with SAD making it necessary to timely intervene during early stages of the disorder and determine what works better why and for whom when trying to change the course of social anxiety in adolescence Cognitive therapy CT has been the treatment of choice for adult SAD but research within adolescent samples is scarce More recently third-wave cognitive approaches namely compassion-focused therapy CFT and acceptance and commitment therapy ACT have also proven effective in treating mental disorders but their efficacy towards adolescents SAD remains unclear
This research project intended to evaluate and compare the therapeutic efficacy of CT CFT and ACT as applied to adolescents with SAD in comparison with waiting-listed after intervention and over a 12-weeks and a 24-weeks follow-up using a randomized parallel trial approach This methodology will allow to test if intervened subjects diverge from the non-intervened SAD subjects and if therapeutic change differs across intervention conditions Therapeutic change process will be investigated specifically if efficacy is mediated by change in the core constructs of each theoretical framework Finally moderators of change such the initial level of symptomology will be examined as to determine which intervention works best for whom The same procedures will be repeated for each intervention condition namely recruitment intervention and assessment
This research will provide evidence on which form of therapy may be the optimal choice in to intervene in SAD in general and when dealing with diverse specific vulnerabilities associated with social fears It will also add to the field of empirically validated therapies with a specific focus on adolescence From a societal perspective the project will assist in empowering schools to contribute to shape how their students act and develop into socially apt adults
This research project intended to evaluate and compare the therapeutic efficacy of CT CFT and ACT as applied to adolescents with SAD in comparison with waiting-listed after intervention and over a 12-weeks and a 24-weeks follow-up using a randomized parallel trial approach This methodology will allow to test if intervened subjects diverge from the non-intervened SAD subjects and if therapeutic change differs across intervention conditions Therapeutic change process will be investigated specifically if efficacy is mediated by change in the core constructs of each theoretical framework Finally moderators of change such the initial level of symptomology will be examined as to determine which intervention works best for whom The same procedures will be repeated for each intervention condition namely recruitment intervention and assessment
This research will provide evidence on which form of therapy may be the optimal choice in to intervene in SAD in general and when dealing with diverse specific vulnerabilities associated with social fears It will also add to the field of empirically validated therapies with a specific focus on adolescence From a societal perspective the project will assist in empowering schools to contribute to shape how their students act and develop into socially apt adults
Detailed Description:
Social anxiety is characterized by emotional reactivity to social events in which individuals believes they can be subject to the scrutiny of others Although normative during adolescence along with the growing importance attributed to acceptance and integration with peers it can come to fulfill criteria for social anxiety disorder SAD McNeil 2010 which is an intense and disabling experience for adolescents Rao et al 2007 SAD refers to excessive and persistent fear of being evaluated in social interactions also with peers which leads to those situations being faced with high levels of suffering or if possible avoided APA 2013 If not subject to specialized intervention SAD usually has a chronic course and is associated with the emergence of other psychiatric disorders Essau et al 2004 In Portugal it is estimated about 8 of adolescents in the community meet criteria for SAD including intense anxiety and frequent avoidance of social situations as well as severe impairment of academic and social functioning and quality of life Most of these adolescents roughly 94 did not seek or were referred to specialized intervention Vagos et al 2021 which points to the importance of offering acceptable practical and effective forms of intervention for PAS
With adults the treatment of choice for SAD is Cognitive Therapy CT Mavranezouli et al 2015 derived from the model by Clark and Wells 1995 This model proposes that social anxiety is maintained by cognitive biases ie negative automatic thinking and self-focused attention that support the practice of safety or avoidance behaviors so that the intervention is aimed at making the focus of attention more flexible in order to be able to invest in and be exposed to social situations and extract evidence from them that may help adjust ones own thoughts and social expectations Based on a review of evidence of the presence of various components of this model also in adolescents Leigh and Clark 2018 propose that it could be applicable to the understanding and intervention in SAD in adolescents contributing to better therapeutic results In fact previous work supports the therapeutic effectiveness Leigh et al 2021 Leigh Clark 2016 and applicability of this approach in different contexts Creswell et al 2021 Leigh et al 2021
While cognitive therapy focuses on modifying the cognitive content elicited by self-focused attention during social events as a means of preventing safety andor avoidance behaviors in these situations Clark Wells 1995 third-generation therapies ie Compassion-focused Therapy - CFT and Acceptance and Commitment Therapy - ACT emphasize the modification of the way the person relates to these cognitive contents CFT proposes that this relationship be based on a compassionate attitude given that psychopathology is based on a relationship with ones own internal experiences that is excessively critical and punishing also in children and adolescents Carona et al 2017 There is previous evidence pointing to the association between self-compassion and social anxiety in adults Werner et al 2012 and adolescents Gill et al 2012 as well as to the effectiveness of CFT for SAD in adults Boersma al 2018 Gharraee et al 2018 As for ACTC its application with adolescents is also conceived assuming that psychopathology results from an avoidant relationship with ones own negative internal experiences Hallibturton Cooper 2015 Still along with the scant evidence linking its core constructs ie psychological flexibility to social anxiety research on the efficacy of this intervention for SAD is scarce although pointing to promising results with adults Dalrymple Herbert 2007 Khoramnia et al 2020 Ossman et al 2006 The applicability of these therapies to SAD in adolescence remains to be elucidated
In view of the above evidence on the efficacy of the therapeutic offer for SAD in adolescence is still scarce So it is relevant to explore the therapeutic results of CT CFT and ACT as well as to explore the mechanisms by which each one enables change and with whom it can be most effective Previous research has pointed to the importance of changing core constructs in the CBT intervention with adults with SAD eg Santoft et al 2019 but evidence regarding the therapeutic approaches under study is scarce In addition and considering the relevance of the intervention being adjusted to the characteristics of the person receiving the intervention Beck et al 2010 it is important to explore the moderators of therapeutic change namely with regard to the severity of symptoms within what is proposed to be the main psychological vulnerability for each of the approaches under analysis
The present work used a parallel clinical trial methodology although different parallel conditions were collected sequentially over time to assess the efficacy of three therapeutic approaches ie CT CFT and ACT with adolescents with SAD compared to a waiting list control group and using four data collection times ie pre-interventiontime 0 post-interventiontime 1 12-weeks follow-uptime3 and 24-month follow-uptime 4 All participants included in the waiting-list control group were offered the opportunity to receive psychological intervention after the waiting period All procedures involved in this study ie sampling data collection to assess the efficacy of the intervention and implementation of the intervention were implemented after a positive position from the Ethics Committee of the institution hosting the investigation authorization from the General Directorate of Education on the data collection protocol to be implemented partnership with national secondary schools authorization of legal guardians of adolescents and consent of the adolescents themselves Furthermore this investigation complied with all applicable ethical and deontological requirements
The sampling process included two phases The first phase was the screening of participants Collaboration protocols were established with 26 secondary schools so that all 10th and 11th grade students of a school were invited to fill out a self-report questionnaire that assesses social anxiety thus contributing to homogeneity with regard to the age group and social and academic experiences of the potential participants Students with scores on this questionnaire above the normative average in Portugal were invited to participate in an individual assessment through a semi-structured diagnostic interview to verify compliance with the inclusion and exclusion criteria described elsewhere in this form Having fulfilled these criteria adolescents were invited to join the study and fill out selected primary and secondary outcome measures to assess the efficacy of the interventions They were firstly allocated to the waiting list-control group later participants from the waiting-list as well as newly recruited participants were sequentially allocated to one of the intervention groups over time The waiting-list control group was recruited in the first year of the research Fifty-two participants initially accepted to participate in the study but only 41 adolescents responded to at least one assessment moment with the other 11 refusing to participant before any assessment moment The 41 participants were contacted at the four evaluation moments as stated above Of these 21 participants completed all assessment moments Participants initially allocated to the waiting-list control condition including the ones that did not complete the 4 assessment moments were contacted to be re-evaluated in the beginning of the second year of the research The ones still fulfilling the inclusion criteria were offered the possibility of receiving an intervention ie of being allocated to an experimental condition Of the 52 participants that initially accepted to participate in the study we were able to contact and evaluate 30 of them - 28 still met criteria for inclusion in an experimental group 1 did not present SAD symptoms and 1 was receiving psychological intervention Of the 28 participants fulfilling inclusion criteria 3 refused the intervention and 25 were randomly allocated to the CFT or CT condition 20 to the CFT and 5 to the CT condition along with another newly recruited 20 participants 18 to the CT and 2 to the CFT interventions At this moment 22 participants had been allocated to the CFT condition 1 of which dropped out and 23 were allocated to the CT condition 6 of which dropped out At the end of the second year of the research project 21 participants had completed the CFT intervention and 17 had completed the CT intervention In the third year of the project 28 adolescents 3 screened in the second year of the project and 25 screened in the second year of the project were recruited and assigned to the ACT and CT conditions 4 to the CT intervention and 24 to the ACT intervention so that all conditions had the minimum number of participants necessary for data analysis Two participants dropped out of the ACT condition In total 92 participants enrolled in the study All participants in all conditions were followed and continue to be followed over the four defined moments Additionally participants werewill be evaluated to verify the presence or absence of SAD at the 24-month follow-uptime 4 using the same semi-structured diagnostic interview used to assess initial inclusionexclusion criteria
Interventions followed a structured brief manual ie 10 weekly sessions and 2 booster sessions 1 and 2 months after the core program was completed and were implemented in individual online format via videoconference according to the time availability of each adolescent the facilitator had adequate training in psychology and in the therapeutic approach to be implemented
Collected data will be used to investigate the therapeutic efficacy of each for the experimental intervention conditions across the four assessment moments on its own in comparison with each other and comparing to a waiting-list control condition Psychotherapeutic efficacy is usually tested against waiting-list control groups based on the assumption that if the intervention and control groups started similarly at pre-intervention and present differently at post-intervention the intervention is responsible for the observed change This procedure is well established in the literature but has seldom been applied to adolescent SAD or to the different theoretical approaches tackled in this trial Processes of change will also be analyzed as reflected in therapeutic change in constructs that were considered transversal to the intervention eg social anxiety being mediated by change in core constructs for each intervention In addition the moderating effect of initial levels of interference and intensity of symptomatology will be explored across experimental intervention conditions
With adults the treatment of choice for SAD is Cognitive Therapy CT Mavranezouli et al 2015 derived from the model by Clark and Wells 1995 This model proposes that social anxiety is maintained by cognitive biases ie negative automatic thinking and self-focused attention that support the practice of safety or avoidance behaviors so that the intervention is aimed at making the focus of attention more flexible in order to be able to invest in and be exposed to social situations and extract evidence from them that may help adjust ones own thoughts and social expectations Based on a review of evidence of the presence of various components of this model also in adolescents Leigh and Clark 2018 propose that it could be applicable to the understanding and intervention in SAD in adolescents contributing to better therapeutic results In fact previous work supports the therapeutic effectiveness Leigh et al 2021 Leigh Clark 2016 and applicability of this approach in different contexts Creswell et al 2021 Leigh et al 2021
While cognitive therapy focuses on modifying the cognitive content elicited by self-focused attention during social events as a means of preventing safety andor avoidance behaviors in these situations Clark Wells 1995 third-generation therapies ie Compassion-focused Therapy - CFT and Acceptance and Commitment Therapy - ACT emphasize the modification of the way the person relates to these cognitive contents CFT proposes that this relationship be based on a compassionate attitude given that psychopathology is based on a relationship with ones own internal experiences that is excessively critical and punishing also in children and adolescents Carona et al 2017 There is previous evidence pointing to the association between self-compassion and social anxiety in adults Werner et al 2012 and adolescents Gill et al 2012 as well as to the effectiveness of CFT for SAD in adults Boersma al 2018 Gharraee et al 2018 As for ACTC its application with adolescents is also conceived assuming that psychopathology results from an avoidant relationship with ones own negative internal experiences Hallibturton Cooper 2015 Still along with the scant evidence linking its core constructs ie psychological flexibility to social anxiety research on the efficacy of this intervention for SAD is scarce although pointing to promising results with adults Dalrymple Herbert 2007 Khoramnia et al 2020 Ossman et al 2006 The applicability of these therapies to SAD in adolescence remains to be elucidated
In view of the above evidence on the efficacy of the therapeutic offer for SAD in adolescence is still scarce So it is relevant to explore the therapeutic results of CT CFT and ACT as well as to explore the mechanisms by which each one enables change and with whom it can be most effective Previous research has pointed to the importance of changing core constructs in the CBT intervention with adults with SAD eg Santoft et al 2019 but evidence regarding the therapeutic approaches under study is scarce In addition and considering the relevance of the intervention being adjusted to the characteristics of the person receiving the intervention Beck et al 2010 it is important to explore the moderators of therapeutic change namely with regard to the severity of symptoms within what is proposed to be the main psychological vulnerability for each of the approaches under analysis
The present work used a parallel clinical trial methodology although different parallel conditions were collected sequentially over time to assess the efficacy of three therapeutic approaches ie CT CFT and ACT with adolescents with SAD compared to a waiting list control group and using four data collection times ie pre-interventiontime 0 post-interventiontime 1 12-weeks follow-uptime3 and 24-month follow-uptime 4 All participants included in the waiting-list control group were offered the opportunity to receive psychological intervention after the waiting period All procedures involved in this study ie sampling data collection to assess the efficacy of the intervention and implementation of the intervention were implemented after a positive position from the Ethics Committee of the institution hosting the investigation authorization from the General Directorate of Education on the data collection protocol to be implemented partnership with national secondary schools authorization of legal guardians of adolescents and consent of the adolescents themselves Furthermore this investigation complied with all applicable ethical and deontological requirements
The sampling process included two phases The first phase was the screening of participants Collaboration protocols were established with 26 secondary schools so that all 10th and 11th grade students of a school were invited to fill out a self-report questionnaire that assesses social anxiety thus contributing to homogeneity with regard to the age group and social and academic experiences of the potential participants Students with scores on this questionnaire above the normative average in Portugal were invited to participate in an individual assessment through a semi-structured diagnostic interview to verify compliance with the inclusion and exclusion criteria described elsewhere in this form Having fulfilled these criteria adolescents were invited to join the study and fill out selected primary and secondary outcome measures to assess the efficacy of the interventions They were firstly allocated to the waiting list-control group later participants from the waiting-list as well as newly recruited participants were sequentially allocated to one of the intervention groups over time The waiting-list control group was recruited in the first year of the research Fifty-two participants initially accepted to participate in the study but only 41 adolescents responded to at least one assessment moment with the other 11 refusing to participant before any assessment moment The 41 participants were contacted at the four evaluation moments as stated above Of these 21 participants completed all assessment moments Participants initially allocated to the waiting-list control condition including the ones that did not complete the 4 assessment moments were contacted to be re-evaluated in the beginning of the second year of the research The ones still fulfilling the inclusion criteria were offered the possibility of receiving an intervention ie of being allocated to an experimental condition Of the 52 participants that initially accepted to participate in the study we were able to contact and evaluate 30 of them - 28 still met criteria for inclusion in an experimental group 1 did not present SAD symptoms and 1 was receiving psychological intervention Of the 28 participants fulfilling inclusion criteria 3 refused the intervention and 25 were randomly allocated to the CFT or CT condition 20 to the CFT and 5 to the CT condition along with another newly recruited 20 participants 18 to the CT and 2 to the CFT interventions At this moment 22 participants had been allocated to the CFT condition 1 of which dropped out and 23 were allocated to the CT condition 6 of which dropped out At the end of the second year of the research project 21 participants had completed the CFT intervention and 17 had completed the CT intervention In the third year of the project 28 adolescents 3 screened in the second year of the project and 25 screened in the second year of the project were recruited and assigned to the ACT and CT conditions 4 to the CT intervention and 24 to the ACT intervention so that all conditions had the minimum number of participants necessary for data analysis Two participants dropped out of the ACT condition In total 92 participants enrolled in the study All participants in all conditions were followed and continue to be followed over the four defined moments Additionally participants werewill be evaluated to verify the presence or absence of SAD at the 24-month follow-uptime 4 using the same semi-structured diagnostic interview used to assess initial inclusionexclusion criteria
Interventions followed a structured brief manual ie 10 weekly sessions and 2 booster sessions 1 and 2 months after the core program was completed and were implemented in individual online format via videoconference according to the time availability of each adolescent the facilitator had adequate training in psychology and in the therapeutic approach to be implemented
Collected data will be used to investigate the therapeutic efficacy of each for the experimental intervention conditions across the four assessment moments on its own in comparison with each other and comparing to a waiting-list control condition Psychotherapeutic efficacy is usually tested against waiting-list control groups based on the assumption that if the intervention and control groups started similarly at pre-intervention and present differently at post-intervention the intervention is responsible for the observed change This procedure is well established in the literature but has seldom been applied to adolescent SAD or to the different theoretical approaches tackled in this trial Processes of change will also be analyzed as reflected in therapeutic change in constructs that were considered transversal to the intervention eg social anxiety being mediated by change in core constructs for each intervention In addition the moderating effect of initial levels of interference and intensity of symptomatology will be explored across experimental intervention conditions
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| POCI-01-0145-FEDER-029445 | OTHER_GRANT | Fundo Europeu de Desenvolvimento Regional | None |