Changing the Course of Social Anxiety in Adolescence
TeenSAD
2 other identifiers
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2019
CompletedFirst Submitted
Initial submission to the registry
July 15, 2021
CompletedFirst Posted
Study publicly available on registry
July 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 17, 2024
May 1, 2024
4 years
July 15, 2021
May 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
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.
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.
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.
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.
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 Outcomes (8)
Change in Safety Behaviors in Social Situations Scale for Adolescents
Baseline, Week 10, Week 22, Week 34.
Change in Social Thoughts and Beliefs Scale
Baseline, Week 10, Week 22, Week 34.
Change in Self-focused Attention Scale
Baseline, Week 10, Week 22, Week 34.
Change in Self-compassion Scale for Adolescents
Baseline, Week 10, Week 22, Week 34.
Change in Other as Shamer Scale - Brief for Adolescents
Baseline, Week 10, Week 22, Week 34.
- +3 more secondary outcomes
Study Arms (4)
Cognitive Therapy
EXPERIMENTALExperimental 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
EXPERIMENTALExperimental 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
EXPERIMENTALExperimental 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 COMPARATORGroup 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).
Interventions
Experimental psychotherapy based on the cognitive model for social anxiety disorder, applied individually and remotely to participants fulfilling inclusion criteria.
Experimental psychotherapy based on the principles of the compassion-focused model, applied individually and remotely to participants fulfilling inclusion criteria.
Experimental psychotherapy based on the principles of the acceptance and commitment model, applied individually and remotely to participants fulfilling inclusion criteria.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculdade de Psicologia e Ciências da Educação - Universidade de Coimbra
Coimbra, 3000-011, Portugal
Related Publications (37)
American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author.
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BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The principal investigator is unaware of which participants are allocated to which condition; she is only aware of the inclusion criteria all participants must fulfill. The investigator and outcome assessor/data analyst are also unaware of treatment outcome and blind to the allocation condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
July 15, 2021
First Posted
July 28, 2021
Study Start
March 15, 2019
Primary Completion
February 27, 2023
Study Completion
December 31, 2023
Last Updated
May 17, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share
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.