Social Anxiety DisorderTeenSADNCT04979676
Changing the Course of Social Anxiety in Adolescence
A study testing Cognitive Therapy, Compassion-focused Therapy and Acceptance and Commitment Therapy in people with Social Anxiety Disorder, run by University of Coimbra at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cognitive Therapy, Compassion-focused Therapy and Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Mar 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion criteria for all experimental and the control group are:
- Aged between 15 and 18 years old at screening phase;
- Self-reported intensity of social anxiety higher than that reported by a normative comparable sample (Cunha et al., 2004);
- Main diagnosis of Social Anxiety Disorder as evaluated via the Mini-Kid (Rijo et al., 2016).
Exclusion criteria for all experimental and the control group are:
- Psychotic symptoms or suicidal risk as assessed via the Mini-Kid (Rijo et al., 2016);
- Being part of the special needs teaching system;
- Currently receiving psychological intervention/counselling.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculdade de Psicologia e Ciências da Educação - Universidade de Coimbra
Coimbra, 3000-011
About this study
Official title: Changing the Course of Social Anxiety in Adolescence: What Works, Why, and for Whom
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.
Read the 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 (i.e., 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 one's 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 and/or avoidance behaviors in these situations (Clark \& Wells, 1995), third-generation therapies (i.e., 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 one's 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 (i.e., 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 (e.g., 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 (i.e., CT, CFT and ACT) with adolescents with SAD, compared to a waiting list control group, and using four data collection times (i.e., pre-intervention/time 0, post-intervention/time 1, 12-weeks follow-up/time3, and 24-month follow-up/time 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 (i.e., 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 (i.e., 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 were/will be evaluated to verify the presence or absence of SAD at the 24-month follow-up/time 4 using the same semi-structured diagnostic interview used to assess initial inclusion/exclusion criteria.
Interventions followed a structured brief manual (i.e., 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 (e.g., 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.
- Conditions
- Social Anxiety Disorder
- Being tested
- Cognitive Therapy, Compassion-focused Therapy, Acceptance and Commitment Therapy
- Keywords
- Social Anxiety Disorder, Adolescence, Therapeutic Change, Therapeutic Efficacy, Therapeutic Processes
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TherapyBehavioural
Also called CT@TeenSAD
Experimental psychotherapy based on the cognitive model for social anxiety disorder, applied individually and remotely to participants fulfilling inclusion criteria.
Compassion-focused TherapyBehavioural
Also called CFT@TeenSAD
Experimental psychotherapy based on the principles of the compassion-focused model, applied individually and remotely to participants fulfilling inclusion criteria.
Acceptance and Commitment TherapyBehavioural
Also called ACT@TeenSAD
Experimental psychotherapy based on the principles of the acceptance and commitment model, applied individually and remotely to participants fulfilling inclusion criteria.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy | Experimental | Experimental group subjected to active individual psychotherapy based on developing skills relating to flexibility of attention, which in turn sustains adolescents adopting a more realistic perspective on social events and acting based on external (and not only internal) social information. Assessed weekly during the intervention period on symptom change. Also assessed at pre-intervention, post-intervention (i.e., 10 to 12 weeks later), 12-weeks follow, and 24-weeks follow-up. Receives: Behavioral: Cognitive Therapy |
| Compassion-focused Therapy | Experimental | Experimental group subjected to active individual psychotherapy based on developing skills relating to flexibility of attention, which in turn sustains adolescents adopting a more realistic perspective on social events and acting based on external (and not only internal) social information. Assessed weekly during the intervention period on symptom change. Also assessed at pre-intervention, post-intervention (i.e., 10 to 12 weeks later), 12-weeks follow, and 24-weeks follow-up. Receives: Behavioral: Compassion-focused Therapy |
| Acceptance and Commitment Therapy | Experimental | Experimental group subjected to active individual psychotherapy based on developing skills for acceptance, defusing, and focusing on the present moments, which in turn sustain acting in social events in line with ones valued actions instead of prioritizing the avoidance of negative internal experiences). Assessed weekly during the intervention period on symptom change. Also assessed at pre-intervention, post-intervention (i.e., 10 to 12 weeks later), 12-weeks follow, and 24-weeks follow-up. Receives: Behavioral: Acceptance and Commitment Therapy |
| Waiting-list control | Placebo comparator | Group of participants with a main dignosis os social anxiety disorder not subjected to any psychological intervention within the current trial. Assessed at time 0, then at time 1 ten to twelve weeks after time 1, then again at time 3 twelve weeks later, and then again at time 4 another twelve weeks later (i.e., 24 weeks after time 1). Receives: Behavioral: Cognitive Therapy; Behavioral: Compassion-focused Therapy; Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social anxiety and Avoidance Scale for Adolescents - Anxiety scale
Self-report instrument used to assess intensity of discomfort felt when: 1) Interacting in new social events, 2) Interacting with the opposite sex, 3) Interacting assertively, 4) Performing in formal social situations, 5) Performing in new social situations, and 6) Eating and drinking in public. Previous psychometric information indicates factorial validity for the six-factor measurement model via exploratory and confirmatory factor analyses, very good internal consistency values for all measures, convergent validity in relation to other measures of anxious and depressive symptoms, and measurement invariance across gender and age (Cunha et al., 2008; Vagos et al., 2013).
Measured: Baseline, Week 10, Week 22, Week 34.
Change in Social anxiety and Avoidance Scale for Adolescents - Avoidance scale
Self-report instrument used to assess frequency of avoidance of: 1) Interacting in new social events, 2) Interacting with the opposite sex, 3) Interacting assertively, 4) Performing in formal social situations, 5) Performing in new social situations, and 6) Eating and drinking in public. Previous psychometric information indicates factorial validity for the six-factor measurement model via exploratory and confirmatory factor analyses, very good internal consistency values for all measures, convergent validity in relation to other measures of anxious and depressive symptoms, and measurement invariance across gender and age (Cunha et al., 2008; Vagos et al., 2013).
Measured: Baseline, Week 10, Week 22, Week 34.
Change in Sheehan disability scale
Self-report instrument used to assess functional impairment caused by social anxiety symptomatology at three inter-related domains: school/ academic performance, social life, and family life. Has previously proved to be sensitive in discriminating the presence/ absence of psychopathology (Pinto-Gouveia et al., 2000).
Measured: Baseline, Week 10, Week 22, Week 34.
Change in Clinical Global Impression Scale for Social Anxiety
Clinician report of social anxiety symptoms. Has previously shown construct validity in relation to self-reported and clinician-administered measures of social anxiety, depression, impairment, and quality of life (Zaider et al., 2003). Includes measures of severity and change.
Measured: Severity will be assessed at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 Week 7, Week, 8, Week 9, Week 10, Week 34. Change will be assessed at Week 2, Week 3, Week 4, Week 5, Week 6 Week 7, Week, 8, Week 9, Week 10.
Social Anxiety Session Change Index
Self-report instrument used to assess how participants in the experimental groups perceive to have changed since the beginning of treatment in level of anxiety in social/ performance events, in avoidance of those events, in concern about embarrassing or humiliating themselves, and in social anxiety related daily interference. Has previously shown adequate internal consistency, validity in relation to concurrent perceived change in fear of negative evaluation, validity in relation to social anxiety, and severity of symptoms and improvement as reported by the clinician (Hayes et al., 2008).
Measured: Week 2, Week 3, Week 4, Week 5, Week 6 Week 7, Week, 8, Week 9, Week 10.
Change in diagnostic assignment
Participants were/will be evaluated to verify the presence or absence of SAD at the 24-month follow-up/time 4 using the same semi-structured diagnostic interview used to assess initial inclusion/exclusion criteria.
Measured: Baseline e week 34
Secondary outcomes (8)
Change in Safety Behaviors in Social Situations Scale for Adolescents
Self-report instrument used to assess practice of safety behaviors in social situations. Has previously shown factorial validity of the one-factor measurement model via exploratory factor analyses, good internal consistency and temporal stability, construct validity in relation to measures of social anxiety, criterion validity in relation to the presence/ absence of social anxiety disorder, and sensitivity to therapeutic change (Silva et al., 2010).
Measured: Baseline, Week 10, Week 22, Week 34.
Change in Social Thoughts and Beliefs Scale
Self-report instrument used to assess negative automatic thoughts common in socially anxious individuals, pertaining to discomfort in social interactions and to discomfort in public performance. Has previously shown factorial validity of a two-factor measurement model via exploratory factor analyses, very good internal consistency for all measures, and convergent validity in relation to a measure of social anxiety (Vagos et al., 2010).
Measured: Baseline, Week 10, Week 22, Week 34.
Change in Self-focused Attention Scale
Self-report instrument used to assess focus of attention in social situations, namely focus of attention in one's behavior and focus of attention in one's physiological arousal. Has previously shown factorial validity of a two-factor measurement model via exploratory factor analyses and good to excellent internal consistency for both factors (Fontinho e Salvador, 2012).
Measured: Baseline, Week 10, Week 22, Week 34.
Change in Self-compassion Scale for Adolescents
Self-report instrument used to assess external shame. Has previously shown factorial validity of the one-factor measurement model via confirmatory analyses, very good internal consistency, measurement invariance across gender, convergent validity in relation to measures of depressive, anxious and stress symptoms, self-criticism and self-reassurance, and experiential avoidance (Vagos et al., 2016).
Measured: Baseline, Week 10, Week 22, Week 34.
Change in Other as Shamer Scale - Brief for Adolescents
Self-report instrument used to assess external shame. Has previously shown factorial validity of the one-factor measurement model via confirmatory analyses, very good internal consistency, measurement invariance across gender, convergent validity in relation to measures of depressive, anxious and stress symptoms, self-criticism and self-reassurance, and experiential avoidance (Vagos et al., 2016).
Measured: Baseline, Week 10, Week 22, Week 34.
Change in Forms of self-criticizing/attacking & self-reassuring scale - Adolescents
Self-report instrument used to assess self-criticism and the ability to self-reassure, by measuring perceptions of an inadequate self, of a reassured self, and of a hated self. Has previously shown factorial validity for the three-factor measurement model via principal component analysis followed by varimax rotation, acceptable to excellent internal consistency for all factors, and convergent validity in relation to measures of anxiety and depression (Silva e Salvador, 2011).
Measured: Baseline, Week 10, Week 22, Week 34.
Change in Avoidance and Fusion Questionnaire for Youth
Self-report instrument used to assess psychological inflexibility. Has previously shown factorial validity of the one-factor measurement model via confirmatory factor analyses, very good internal consistency and temporal stability, and construct validity in relation with acceptance/ mindfulness, depressive and anxious symptoms, and social self-concept and comparison (Cunha \& Santos, 2011).
Measured: Baseline, Week 10, Week 22, Week 34.
Change in Social Anxiety - Acceptance and Action Questionnaire
Self-report instrument used to assess experiential acceptance associated with social anxiety symptomatology as reflected in willingness to experience social anxiety symptoms and moving towards valued life directions despite social anxiety symptoms. Has previously shown factorial validity of the two-factor measurement model via confirmatory factor analyses, very good internal consistency and temporal stability, construct validity in relation to measures of social anxiety, of mindfulness/ acceptance, and other anxious and depressive symptoms, criterion validity in relation to the presence/ absence of social anxiety disorder (Martins et al., 2015).
Measured: Baseline, Week 10, Week 22, Week 34.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start15 Mar 2019
- Primary completion27 Feb 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This work uses a randomized and parallel clinical trial methodology (although the different parallel conditions are collected sequentially over the duration of the trial) to assess the effectiveness of three therapeutic approaches (i.e., CT, CFT and ACT) with adolescents with SAD, compared to a waiting-list control group. Originally, participants were to be sequentially and over time recruited and allocated to the different parallel conditions (i.e., assignment to CT or to a wait-list control condition in the first year; assignment to CFT or to a wait-list control condition in the second year, and assignment to ACT in the third year). However, the Covid-19 pandemic forced us to adapt the interventions to an online individual format thus delaying the assignment to the experimental conditions. So, all participants recruited in the first year were assigned to the wait-list control group and later randomly allocated to an experimental condition by the responsible investigator.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Responsible party
- Principal investigator, Paula Vagos, University of Coimbra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979676
- Sponsor's protocol ID
- PTDC/PSI-ESP/29445/2017
- Other IDs
- POCI-01-0145-FEDER-029445
- Acronym
- TeenSAD
- Status last verified
- May 2024
- First submitted
- 15 Jul 2021
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared as participants were guaranteed anonymity and confidentiality of their individual data. Datasets with alphanumerical identities given to each participant may be made available, either by publishing data or upon reasonable request directed at with the principal investigator.
Publications
American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author.
Beck C, McSweeney JC, Richards KC, Roberson PK, Tsai PF, Souder E. Challenges in tailored intervention research. Nurs Outlook. 2010 Mar-Apr;58(2):104-10. doi: 10.1016/j.outlook.2009.10.004.
PubMed 20362779Boersma, K., Håkanson, A., Salomonsson, E., & Johansson, I. (2014). Compassion Focused Therapy to counteract shame, self-criticism and isolation. A replicated single case experimental study for individuals with social anxiety. Journal of Contemporary Psychotherapy, 45(2), 89-98. https://doi.org/10.1007/s10879-014-9286-8
Carona, C., Rijo, D., Salvador, M.C., Castilho, P., & Gilbert, P. (2018). Compassion-focused therapy with children and adolescents. BJPsych Advances, 23(4), 240-252. https://doi.org/10.1192/apt.bp.115.015420
Clark, D. M., & Wells, A. (1995). A cognitive model of social phobia. In G. Heimberg, M. R. M. R. Liebowitz, D. Hope, & F. Scheier (Eds.), Social phobia: Diagnosis, assessment, and treatment (pp. 69-93). New York: The Guilford Press.
Creswell C, Leigh E, Larkin M, Stephens G, Violato M, Brooks E, Pearcey S, Taylor L, Stallard P, Waite P, Reynolds S, Taylor G, Warnock-Parkes E, Clark DM. Cognitive therapy compared with CBT for social anxiety disorder in adolescents: a feasibility study. Health Technol Assess. 2021 Mar;25(20):1-94. doi: 10.3310/hta25200.
PubMed 33759742Cunha, M., Pinto-Gouveia, J.P., Alegre, S., & Salvador, M.C. (2004). Avaliação da ansiedade na adolescência: A versão portuguesa da SAS-A. Psychologica, 35, 249-263.
Cunha, M., Pinto-Gouveia, J. P., & Salvador, M. C. (2008). Social fears in adolescence - The social anxiety and avoidance scale for adolescents. European Psychologist, 13(3), 197-213. https://doi.org/10.1027/1016-9040.13.3.1974
Cunha, M. & Santos, A.M. (2011). Avaliação da inflexibilidade psicológica em adolescentes: Estudo das qualidades psicométricas da versão portuguesa do Avoidance and Fusion Questionnaire for Youth (AFQ-Y). Laboratório de Psicologia, 9, 133-146.
Cunha, M., Xavier, A., & Vitória, I. (2013). Avaliação da auto-compaixão em adolescentes: Adaptação e qualidades psicométricas da Escala de Auto-Compaixão. Journal of Child and Adolescent Psychology, 4(2), 95-117.
Dalrymple KL, Herbert JD. Acceptance and commitment therapy for generalized social anxiety disorder: a pilot study. Behav Modif. 2007 Sep;31(5):543-68. doi: 10.1177/0145445507302037.
PubMed 17699117Essau CA, Lewinsohn PM, Olaya B, Seeley JR. Anxiety disorders in adolescents and psychosocial outcomes at age 30. J Affect Disord. 2014 Jul;163:125-32. doi: 10.1016/j.jad.2013.12.033. Epub 2014 Jan 2.
PubMed 24456837Fontinho, A. & Salvador, M. C. (2012). O papel da atenção auto focada na fobia social na adolescência: validação da versão portuguesa da Escala de Atenção Auto Focada (SFA) e estudos preliminares [Unpublished master dissertation]. Faculty of Psychology and Educational Sciences of University of Coimbra.
Gharraee, R., Rajrishi, K., Farani, A., Bolhari, J., & Farahani, H. (2018). A randomized controlled trial of compassion focused therapy for social anxiety disorder. Iranian Journal of Psychiatry and Behavioral Sciences, 12(4), e80945. https://doi.org/10.5812/ijpbs.80945
Gill C, Watson L, Williams C, Chan SWY. Social anxiety and self-compassion in adolescents. J Adolesc. 2018 Dec;69:163-174. doi: 10.1016/j.adolescence.2018.10.004. Epub 2018 Oct 13.
PubMed 30326397
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the Course of Social Anxiety in Adolescence: What Works, Why, and for Whom
- ClinicalTrials.gov ID
- NCT04979676
- Acronym / sponsor ID
- TeenSAD / PTDC/PSI-ESP/29445/2017
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety Disorder, Adolescence, Therapeutic Change, Therapeutic Efficacy, Therapeutic Processes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (i.e., 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 one's 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 and/or avoidance behaviors in these situations (Clark \& Wells, 1995), third-generation therapies (i.e., 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 one's 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 (i.e., 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 (e.g., 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 (i.e., CT, CFT and ACT) with adolescents with SAD, compared to a waiting list control group, and using four data collection times (i.e., pre-intervention/time 0, post-intervention/time 1, 12-weeks follow-up/time3, and 24-month follow-up/time 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 (i.e., 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 (i.e., 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 were/will be evaluated to verify the presence or absence of SAD at the 24-month follow-up/time 4 using the same semi-structured diagnostic interview used to assess initial inclusion/exclusion criteria.
Interventions followed a structured brief manual (i.e., 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 (e.g., 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This work uses a randomized and parallel clinical trial methodology (although the different parallel conditions are collected sequentially over the duration of the trial) to assess the effectiveness of three therapeutic approaches (i.e., CT, CFT and ACT) with adolescents with SAD, compared to a waiting-list control group. Originally, participants were to be sequentially and over time recruited and allocated to the different parallel conditions (i.e., assignment to CT or to a wait-list control condition in the first year; assignment to CFT or to a wait-list control condition in the second year, and assignment to ACT in the third year). However, the Covid-19 pandemic forced us to adapt the interventions to an online individual format thus delaying the assignment to the experimental conditions. So, all participants recruited in the first year were assigned to the wait-list control group and later randomly allocated to an experimental condition by the responsible investigator.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy | Experimental | Behavioral: Cognitive TherapyExperimental group subjected to active individual psychotherapy based on developing skills relating to flexibility of attention, which in turn sustains adolescents adopting a more realistic perspective on social events and acting based on external (and not only internal) social information. Assessed weekly during the intervention period on symptom change. Also assessed at pre-intervention, post-intervention (i.e., 10 to 12 weeks later), 12-weeks follow, and 24-weeks follow-up. |
| Compassion-focused Therapy | Experimental | Behavioral: Compassion-focused TherapyExperimental group subjected to active individual psychotherapy based on developing skills relating to flexibility of attention, which in turn sustains adolescents adopting a more realistic perspective on social events and acting based on external (and not only internal) social information. Assessed weekly during the intervention period on symptom change. Also assessed at pre-intervention, post-intervention (i.e., 10 to 12 weeks later), 12-weeks follow, and 24-weeks follow-up. |
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyExperimental group subjected to active individual psychotherapy based on developing skills for acceptance, defusing, and focusing on the present moments, which in turn sustain acting in social events in line with ones valued actions instead of prioritizing the avoidance of negative internal experiences). Assessed weekly during the intervention period on symptom change. Also assessed at pre-intervention, post-intervention (i.e., 10 to 12 weeks later), 12-weeks follow, and 24-weeks follow-up. |
| Waiting-list control | Placebo comparator | Behavioral: Cognitive Therapy, Behavioral: Compassion-focused Therapy, Behavioral: Acceptance and Commitment TherapyGroup of participants with a main dignosis os social anxiety disorder not subjected to any psychological intervention within the current trial. Assessed at time 0, then at time 1 ten to twelve weeks after time 1, then again at time 3 twelve weeks later, and then again at time 4 another twelve weeks later (i.e., 24 weeks after time 1). |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TherapyAlso: CT@TeenSADExperimental psychotherapy based on the cognitive model for social anxiety disorder, applied individually and remotely to participants fulfilling inclusion criteria. | Behavioural | Cognitive Therapy, Waiting-list control |
| Compassion-focused TherapyAlso: CFT@TeenSADExperimental psychotherapy based on the principles of the compassion-focused model, applied individually and remotely to participants fulfilling inclusion criteria. | Behavioural | Compassion-focused Therapy, Waiting-list control |
| Acceptance and Commitment TherapyAlso: ACT@TeenSADExperimental psychotherapy based on the principles of the acceptance and commitment model, applied individually and remotely to participants fulfilling inclusion criteria. | Behavioural | Acceptance and Commitment Therapy, Waiting-list control |
Primary outcome
Change in Social anxiety and Avoidance Scale for Adolescents - Anxiety scale
Time frame: Baseline, Week 10, Week 22, Week 34.
Self-report instrument used to assess intensity of discomfort felt when: 1) Interacting in new social events, 2) Interacting with the opposite sex, 3) Interacting assertively, 4) Performing in formal social situations, 5) Performing in new social situations, and 6) Eating and drinking in public. Previous psychometric information indicates factorial validity for the six-factor measurement model via exploratory and confirmatory factor analyses, very good internal consistency values for all measures, convergent validity in relation to other measures of anxious and depressive symptoms, and measurement invariance across gender and age (Cunha et al., 2008; Vagos et al., 2013).
Change in Social anxiety and Avoidance Scale for Adolescents - Avoidance scale
Time frame: Baseline, Week 10, Week 22, Week 34.
Self-report instrument used to assess frequency of avoidance of: 1) Interacting in new social events, 2) Interacting with the opposite sex, 3) Interacting assertively, 4) Performing in formal social situations, 5) Performing in new social situations, and 6) Eating and drinking in public. Previous psychometric information indicates factorial validity for the six-factor measurement model via exploratory and confirmatory factor analyses, very good internal consistency values for all measures, convergent validity in relation to other measures of anxious and depressive symptoms, and measurement invariance across gender and age (Cunha et al., 2008; Vagos et al., 2013).
Change in Sheehan disability scale
Time frame: Baseline, Week 10, Week 22, Week 34.
Self-report instrument used to assess functional impairment caused by social anxiety symptomatology at three inter-related domains: school/ academic performance, social life, and family life. Has previously proved to be sensitive in discriminating the presence/ absence of psychopathology (Pinto-Gouveia et al., 2000).
Change in Clinical Global Impression Scale for Social Anxiety
Time frame: Severity will be assessed at Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6 Week 7, Week, 8, Week 9, Week 10, Week 34. Change will be assessed at Week 2, Week 3, Week 4, Week 5, Week 6 Week 7, Week, 8, Week 9, Week 10.
Clinician report of social anxiety symptoms. Has previously shown construct validity in relation to self-reported and clinician-administered measures of social anxiety, depression, impairment, and quality of life (Zaider et al., 2003). Includes measures of severity and change.
Social Anxiety Session Change Index
Time frame: Week 2, Week 3, Week 4, Week 5, Week 6 Week 7, Week, 8, Week 9, Week 10.
Self-report instrument used to assess how participants in the experimental groups perceive to have changed since the beginning of treatment in level of anxiety in social/ performance events, in avoidance of those events, in concern about embarrassing or humiliating themselves, and in social anxiety related daily interference. Has previously shown adequate internal consistency, validity in relation to concurrent perceived change in fear of negative evaluation, validity in relation to social anxiety, and severity of symptoms and improvement as reported by the clinician (Hayes et al., 2008).
Change in diagnostic assignment
Time frame: Baseline e week 34
Participants were/will be evaluated to verify the presence or absence of SAD at the 24-month follow-up/time 4 using the same semi-structured diagnostic interview used to assess initial inclusion/exclusion criteria.
8 secondary outcomes
Change in Safety Behaviors in Social Situations Scale for Adolescents
Time frame: Baseline, Week 10, Week 22, Week 34.
Change in Social Thoughts and Beliefs Scale
Time frame: Baseline, Week 10, Week 22, Week 34.
Change in Self-focused Attention Scale
Time frame: Baseline, Week 10, Week 22, Week 34.
Change in Self-compassion Scale for Adolescents
Time frame: Baseline, Week 10, Week 22, Week 34.
Change in Other as Shamer Scale - Brief for Adolescents
Time frame: Baseline, Week 10, Week 22, Week 34.
Change in Forms of self-criticizing/attacking & self-reassuring scale - Adolescents
Time frame: Baseline, Week 10, Week 22, Week 34.
Change in Avoidance and Fusion Questionnaire for Youth
Time frame: Baseline, Week 10, Week 22, Week 34.
Change in Social Anxiety - Acceptance and Action Questionnaire
Time frame: Baseline, Week 10, Week 22, Week 34.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
- BackgroundAmerican Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author.
- Background: PubMed 20362779Beck C, McSweeney JC, Richards KC, Roberson PK, Tsai PF, Souder E. Challenges in tailored intervention research. Nurs Outlook. 2010 Mar-Apr;58(2):104-10. doi: 10.1016/j.outlook.2009.10.004.
- BackgroundBoersma, K., Håkanson, A., Salomonsson, E., & Johansson, I. (2014). Compassion Focused Therapy to counteract shame, self-criticism and isolation. A replicated single case experimental study for individuals with social anxiety. Journal of Contemporary Psychotherapy, 45(2), 89-98. https://doi.org/10.1007/s10879-014-9286-8
- BackgroundCarona, C., Rijo, D., Salvador, M.C., Castilho, P., & Gilbert, P. (2018). Compassion-focused therapy with children and adolescents. BJPsych Advances, 23(4), 240-252. https://doi.org/10.1192/apt.bp.115.015420
- BackgroundClark, D. M., & Wells, A. (1995). A cognitive model of social phobia. In G. Heimberg, M. R. M. R. Liebowitz, D. Hope, & F. Scheier (Eds.), Social phobia: Diagnosis, assessment, and treatment (pp. 69-93). New York: The Guilford Press.
- Background: PubMed 33759742Creswell C, Leigh E, Larkin M, Stephens G, Violato M, Brooks E, Pearcey S, Taylor L, Stallard P, Waite P, Reynolds S, Taylor G, Warnock-Parkes E, Clark DM. Cognitive therapy compared with CBT for social anxiety disorder in adolescents: a feasibility study. Health Technol Assess. 2021 Mar;25(20):1-94. doi: 10.3310/hta25200.
- BackgroundCunha, M., Pinto-Gouveia, J.P., Alegre, S., & Salvador, M.C. (2004). Avaliação da ansiedade na adolescência: A versão portuguesa da SAS-A. Psychologica, 35, 249-263.
- BackgroundCunha, M., Pinto-Gouveia, J. P., & Salvador, M. C. (2008). Social fears in adolescence - The social anxiety and avoidance scale for adolescents. European Psychologist, 13(3), 197-213. https://doi.org/10.1027/1016-9040.13.3.1974
- BackgroundCunha, M. & Santos, A.M. (2011). Avaliação da inflexibilidade psicológica em adolescentes: Estudo das qualidades psicométricas da versão portuguesa do Avoidance and Fusion Questionnaire for Youth (AFQ-Y). Laboratório de Psicologia, 9, 133-146.
- BackgroundCunha, M., Xavier, A., & Vitória, I. (2013). Avaliação da auto-compaixão em adolescentes: Adaptação e qualidades psicométricas da Escala de Auto-Compaixão. Journal of Child and Adolescent Psychology, 4(2), 95-117.
- Background: PubMed 17699117Dalrymple KL, Herbert JD. Acceptance and commitment therapy for generalized social anxiety disorder: a pilot study. Behav Modif. 2007 Sep;31(5):543-68. doi: 10.1177/0145445507302037.
- Background: PubMed 24456837Essau CA, Lewinsohn PM, Olaya B, Seeley JR. Anxiety disorders in adolescents and psychosocial outcomes at age 30. J Affect Disord. 2014 Jul;163:125-32. doi: 10.1016/j.jad.2013.12.033. Epub 2014 Jan 2.
- Individual participant dataSharing planned: No. IPD will not be shared as participants were guaranteed anonymity and confidentiality of their individual data. Datasets with alphanumerical identities given to each participant may be made available, either by publishing data or upon reasonable request directed at with the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Therapy, Compassion-focused Therapy and Acceptance and Commitment Therapy in people with Social Anxiety Disorder, run by University of Coimbra at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social anxiety and Avoidance Scale for Adolescents - Anxiety scale (time frame: Baseline, Week 10, Week 22, Week 34.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04979676, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.