Social Anxiety Disorder Clinical Trial
— TeenSADOfficial title:
Changing the Course of Social Anxiety in Adolescence: What Works, Why, and for Whom
Verified date | May 2024 |
Source | University of Coimbra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | December 31, 2023 |
Est. primary completion date | February 27, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 15 Years to 18 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Portugal | Faculdade de Psicologia e Ciências da Educação - Universidade de Coimbra | Coimbra |
Lead Sponsor | Collaborator |
---|---|
University of Coimbra | Foundation for Science and Technology, Portugal |
Portugal,
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* Note: There are 37 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | Baseline, Week 10, Week 22, Week 34. | |
Primary | 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). | Baseline, Week 10, Week 22, Week 34. | |
Primary | 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). | Baseline, Week 10, Week 22, Week 34. | |
Primary | 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. | 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. | |
Primary | 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). | Week 2, Week 3, Week 4, Week 5, Week 6 Week 7, Week, 8, Week 9, Week 10. | |
Primary | 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. | Baseline e week 34 | |
Secondary | 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). | Baseline, Week 10, Week 22, Week 34. | |
Secondary | 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). | Baseline, Week 10, Week 22, Week 34. | |
Secondary | 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). | Baseline, Week 10, Week 22, Week 34. | |
Secondary | 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). | Baseline, Week 10, Week 22, Week 34. | |
Secondary | 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). | Baseline, Week 10, Week 22, Week 34. | |
Secondary | 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). | Baseline, Week 10, Week 22, Week 34. | |
Secondary | 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). | Baseline, Week 10, Week 22, Week 34. | |
Secondary | 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). | Baseline, Week 10, Week 22, Week 34. |
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