Social Anxiety DisorderNCT05906849
Where We All Meet: ACT Approach to Adolescents Anxiety Disorders
A study testing ACT for anxiety disorders in people with Social Anxiety Disorder and Generalized Anxiety Disorder, run by University of Coimbra at 1 site in Portugal.
Trial summary
Transdiagnostic approaches have been proposed as more truthfully representing mental health problems. Acceptance and Commitment Therapy (ACT) is a transdiagnostic approach that proposes Psychological Inflexibility/Flexibility (PI/PF) as the root of human suffering/flourishing. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder, Generalized Anxiety Disorder
- What is being tested?
- ACT for anxiety disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jan 2023to 30 Sep 2026
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adolescent's sample: No mental health diagnosis;
- Adolescents with SAD sample: Main diagnosis of SAD;
- Adolescents with GAD sample: Main diagnosis of GAD. Note: adolescents presenting both GAD and SAD will be excluded as its inclusion could confound the projects' results and conclusions.
Who cannot join
- Cognitive impairment (assessed through a clinical interview; MINI-KID [37,38]);
- Presence of psychotic symptoms or suicidal ideation (according to the MINI-KID [37,38]);
- Undergoing another treatment (e.g., medication) for a psychiatric condition.
Trial locations and contacts
1 site in 1 country.
Diana V Figueiredo, M.Sc. contact
Portugal1 site, 1 recruiting
- Recruiting
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra
Coimbra
Diana V Figueiredo, 968441870 ext. +351, diana.v.figueiredo@fpce.uc.pt
Diana V Figueiredo
About this study
Official title: Where We All Meet: ACT as a Conceptual and Therapeutic Transdiagnostic Approach to Adolescents With Different Anxiety Disorders
Transdiagnostic approaches have been proposed as more truthfully representing mental health problems. Acceptance and Commitment Therapy (ACT) is a transdiagnostic approach that proposes Psychological Inflexibility/Flexibility (PI/PF) as the root of human suffering/flourishing. ACT has been recognized as conceptually and clinically relevant for adult disorders. However, during adolescence, when anxiety disorders are highly prevalent, the same evidence is scarce. Specifically, methodologically robust designs investigating ACT's efficacy on adolescents' ADs are scarce and mechanisms underlying change during ACT for adolescents with ADs have not been investigated. Therefore, this study aims to adapt, implement, and investigate the efficacy of an online delivered (through videoconference) ACT intervention to adolescents presenting SAD or GAD, thus contributing to amplifying the transdiagnostic application of ACT to these disorders. A Randomized Controlled Trial (RCT) with 3 groups (i.e., Control, GAD intervention, and SAD intervention groups) of adolescents aged between 14 and 18 years old will be conducted. Outcome measurement will be assessed at pre-intervention, post-intervention, and at 3- and 6-month follow-ups. The investigators expect improvements in outcome variables (e.g., anxiety symptoms) at post-treatment for intervention groups. When comparing changes in outcome variables between the control and the intervention groups, improvements are expected only in the groups receiving intervention. Additionally, similar effects on outcome measures are expected in both intervention groups with gains being maintained over time (i.e., at 3- and 6-months follow-up). Finally, changes in PI/PF processes are expected to predict changes in outcome variables in both intervention groups. This RCT will provide valuable insights that can potentially enhance the efficacy of treatment modalities, contributing to improved well-being for adolescents with ADs.
Read the detailed description
Recently, researchers have increasingly focused on understanding commonalities in psychological processes underlying human suffering and psychopathology [1,2]. This has been driven by multiple factors, namely: high comorbidity among mental health problems [e.g., 3,4]; evidence for within-disorder and between-disorder prediction and cascading effects throughout life [e.g., 5,6]; data suggesting that disorder-specific interventions produce improvements in comorbid disorders [e.g., 7,8]; established efficacy of transdiagnostic interventions in multiple disorders [e.g., 9,10]; and their equivalent efficacy to diagnosis-specific interventions [11]. Taken together, research indicates the presence of shared mechanisms, highlighting the need for treatments to target broader processes. Accordingly, transdiagnostic approaches have emerged as promising frameworks, as they may better reflect the complexity and dimensionality of the human experience and more accurately represent the reality of mental health problems.
Acceptance and Commitment Therapy (ACT) is a transdiagnostic approach to behavior change that proposes Psychological Inflexibility (PI) as the root of human suffering in general, and of mental health disorders in particular [12]. PI is defined as rigid attempts to control, alter or minimize unpleasant internal experiences at the expense of the ability to persist and/or change behavior to pursue chosen values. PI steams from six interrelated processes: Cognitive Fusion, Experiential Avoidance, Attachment to the Conceptualized Self, Dominance of the Conceptualized Past/Feared Future, Lack of Values Clarity and Inaction, Impulsivity or Avoidant Persistence [13]. ACT aims to reverse PI processes by cultivating Psychological Flexibility (PF) which refers to the ability to be in contact with the present moment regardless of unpleasant internal experiences while persisting in value-guided behaviors [14]. PF entails six interrelated processes, opposing each PI processes: Cognitive Defusion, Acceptance, Self as Context, Contact with the Present Moment, Values, and Committed Action [12].
Evidence supports ACT's efficacy in adults with various disorders [e.g.,15, 16] as well as the role of PI/PF components as mechanisms of change following ACT [17]. Some studies support that role in adolescents' mental health [18,19] and promising results suggest ACT's efficacy with this population [e.g.,20]. However, most studies did not consider all PI/PF processes [e.g., 21] and there is a scarcity of methodologically robust designs (e.g., Randomized Controlled Trials; RCTs) investigating ACT interventions in adolescents [e.g.,10]. Because most studies did not include extended follow-ups and adolescence is marked by significant and rapid psychological changes [22], ACT's utility to this age group has not been fully assessed. This seems worrisome considering that between 10 to 20% of adolescents experience mental health problems [23]. In youth, anxiety disorders are the most common disorders [24]. Particularly, Social Anxiety Disorder (SAD) and Generalized Anxiety Disorder (GAD) present significant prevalence rates in adolescents [4,25] both typically presenting a chronic course that may evolve into other mental health disorders in adulthood [6,26]. ACT has been proven effective for SAD and GAD treatment in adults [27,28]. Preliminary findings point to ACT being efficacious for treating anxiety in adolescence [23]. However, few studies examined ACT's efficacy for adolescents' SAD [20,29], and only one included adolescents with GAD [20]. Research on the efficacy of ACT to adolescents' SAD and GAD is largely missing, and mechanisms underlying change have not been reported. Increasing the understanding of the common mechanisms underlying mental health problems in adolescents, and how these mechanisms can be used to sustain efficacious psychological interventions, is a crucial research concern.
Thus, this project intends to amplify the transdiagnostic application of ACT to adolescents presenting SAD and GAD. A RCT will be conducted to explore the efficacy and processes of change of ACT for SAD or GAD, considering adolescents' anxiety symptoms and flourishing as outcomes. The research team will adapt, implement, and investigate the efficacy of an online delivered (videoconference) ACT Intervention to adolescents presenting SAD or GAD via: : 1. Changes in primary (i.e., anxiety symptoms) and secondary (i.e., flourishing and PI/PF processes) outcomes following intervention - significant improvements are expected at post-intervention only in the intervention groups (i.e., SAD intervention and GAD intervention groups), in comparison with a clinical control group; 2. Examining the stability of change over time (i.e., 3- and 6-months follow-up) - improvements are expected to maintain; 3. Comparing the efficacy of the intervention between both intervention groups - Similar effects on outcome measures for both clinical groups are expected; 4. Investigating mechanisms of change following intervention in both intervention groups - Similar findings in both intervention groups are expected, with changes in PI/PF predicting changes in outcome variables.
All procedures involved in this project (described elsewhere in this form) were approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences, University of Coimbra and the General Directorate of Education authorized the data collection protocol to be implemented in school contexts. Informed consent from adolescents and their parents/legal guardians will be required for all potential participants prior to any data collection. Adolescents and their parents/legal guardians will be informed that the participation is voluntary and that they can decline to participate at any time during the project without any negative consequence. Moreover, they will be informed that the confidentiality of responses will be assured in all moments.
- Being tested
- ACT for anxiety disorders
- Keywords
- Acceptance and Commitment Therapy, Transdiagnostic Processes, Psychological Flexibility/Inflexibility, Adolescents, Anxiety Disorders
- Medical subject headings
- Phobia, Social, Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT for anxiety disordersBehavioural
A twelve session Acceptance and Commitment Therapy (ACT) for anxiety disorders, applied individually and remotely (through videoconference) to participants fulfilling inclusion criteria (i.e., participants included in the SAD and GAD Experimental Groups).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Group of participants with a main diagnosis of social anxiety disorder (n≥13) or generalized anxiety disorder (n≥13) not subjected to any psychological intervention within the current trial. They will be asked to fill in the self-report protocol at 2 different time points (12 weeks interval) mimicking the pre- and post-intervention assessment moments; these adolescents will be assessed after the second time point and referred to the school psychology services if the difficulties persist. |
| SAD Intervention Group | Experimental | Group of participants with a main diagnosis of social anxiety disorder (n=26) subjected to individual online delivered 12 sessions ACT psychotherapy. Participants pertaining to this group will be assessed at 4 different time points (pre- and post-treatment and at a 3- and 6- month follow-up). Receives: Behavioral: ACT for anxiety disorders |
| GAD Intervention Group | Experimental | Group of participants with a main diagnosis of generalized anxiety disorder (n=26) subjected to individual online delivered 12 sessions ACT psychotherapy. Participants pertaining to this group will be assessed at 4 different time points (pre- and post-treatment and at a 3- and 6- month follow-up). Receives: Behavioral: ACT for anxiety disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Social Anxiety and Avoidance Scale for Adolescents
The SAASA consists of 30 items in its adapted version for late adolescents [30]. It intends to assess the degree of anxiety and frequency of avoidance in social situations representative of the most frequent social fears during adolescence. Each item (e.g., "Going to a party given by a colleague") is answered twice, for two subscales - anxiety and avoidance -, on a five-point Likert scale (ranging from 1 = 'none' to 5 = 'very much' for anxiety; and from 1 = 'never' to 5 = 'almost always' for avoidance). Previous psychometric information indicates very good internal consistency values, convergent validity in relation to other measures of anxious and depressive symptoms, and measurement invariance across gender and age [30, 31]
Measured: Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months
Change in Generalized Anxiety Disorder - 7
The GAD-7 [32,33] is a 7 item self-report scale initially designed to identify probable cases of Generalized Anxiety Disorder (GAD). The GAD-7 assesses Generalized Anxiety Disorder symptoms such as nervousness, uncontrollability of worry, excessive worry, restlessness, difficulty in relaxing and easy irritability. Items (e.g., "Feeling nervous, anxious or on edge") are answered in 4-point Liker scale (ranging from 0='not at all' to 3= 'nearly every day') reporting to the two previous weeks. Higher scores on the GAD-7 represent higher levels of GAD symptoms. Previous psychometric information indicates excellent internal consistency values and divergent validity in relation to measures of quality of life and satisfaction with school [33].
Measured: Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months
Secondary outcomes (2)
Change in the Multidimensional Psychological Flexibility Inventory - 24 (short form)
The MPFI-24 [34] is a 24-item self-report scale for the assessment of psychological flexibility/inflexibility, comprised by 12 subscales, representing psychological flexibility (i.e., Acceptance, Present Moment Awareness, Self as Context, Defusion, Values, Committed Action) and psychological inflexibility (i.e., Experiential Avoidance, Lack of Contact with the Present Moment, Self as Content, Fusion, Lack of Contact with Values, Inaction). Items (e.g., "I opened myself to all of my feelings, the good and the bad") are answered on a 6-point Likert scale (ranging from 1 = 'never true' to 6 = 'always true') reporting to the previous 2 weeks. The scores of the 6 flexibility and 6 inflexibility subscales can be averaged to create a composite score representing global flexibility and inflexibility, respectively. Previous psychometric information indicates good to excellent internal consistency values [34] . This measure is currently being adapted and validated to Portuguese adolescents.
Measured: Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months
Change in Mental Health Continuum - Short Form - for youth
The MHC-SF [35,36] is a 14 items self-report measure that assesses adolescent's flourishing based on levels of subjective well-being across 3 domains: emotional, social and psychological well-being. Following the instructions (i.e., "Please answer the following questions about how you have been feeling during the past month"), items (e.g., "How often do you felt happy?") are answered on a 6-points Likert scale (ranging from 0='Never' to 5='Every day'). Previous psychometric information indicates good internal consistency values and construct validity in relation to measures of quality of life, life satisfaction, anxiety, depression and internalizing and externalizing problems [36] .
Measured: Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jan 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)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
- To attain this project's aims a longitudinal research will take place. Adolescents presenting SAD or GAD will be randomly allocated to a Control Group (no intervention group), or an Experimental Group (individual intervention group). Adolescents with SAD will be randomly allocated to the control group (n≥13), and to the SAD Experimental Group (n=29). Similarly, adolescents with GAD will be randomly allocated to the control group (n≥13), the to the GAD Experimental Group (n=29). Therefore, the Randomized and Parallel Controlled Trial will include a Control Group (N=29), a SAD (n=29) and a GAD (n=29) Experimental Group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (estimated)
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, Diana Vieira Figueiredo, University of Coimbra
- Investigators
- Diana V Figueiredo, M.Sc., Principal investigator, Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), FPCE-UC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906849
- Sponsor's protocol ID
- 2022.13986.BD
- Status last verified
- Jul 2023
- First submitted
- 7 Jun 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levin ME, MacLane C, Daflos S, Seeley J, Hayes SC, Biglan A, Pistorello J. Examining psychological inflexibility as a transdiagnostic process across psychological disorders. J Contextual Behav Sci. 2014 Jul;3(3):155-163. doi: 10.1016/j.jcbs.2014.06.003.
PubMed 29057212[2] Norton, P. (Ed.). (2017). Transdiagnostic Approaches [Special Issue]. 46. https://doi.org/10.1016/j.janxdis.2017.02.004
Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
PubMed 15939837Niermann HCM, Voss C, Pieper L, Venz J, Ollmann TM, Beesdo-Baum K. Anxiety disorders among adolescents and young adults: Prevalence and mental health care service utilization in a regional epidemiological study in Germany. J Anxiety Disord. 2021 Oct;83:102453. doi: 10.1016/j.janxdis.2021.102453. Epub 2021 Jul 10.
PubMed 34303082Asselmann E, Wittchen HU, Lieb R, Beesdo-Baum K. Sociodemographic, clinical, and functional long-term outcomes in adolescents and young adults with mental disorders. Acta Psychiatr Scand. 2018 Jan;137(1):6-17. doi: 10.1111/acps.12792. Epub 2017 Aug 31.
PubMed 28861892Copeland WE, Shanahan L, Costello EJ, Angold A. Childhood and adolescent psychiatric disorders as predictors of young adult disorders. Arch Gen Psychiatry. 2009 Jul;66(7):764-72. doi: 10.1001/archgenpsychiatry.2009.85.
PubMed 19581568Allen LB, White KS, Barlow DH, Shear MK, Gorman JM, Woods SW. Cognitive-Behavior Therapy (CBT) for Panic Disorder: Relationship of Anxiety and Depression Comorbidity with Treatment Outcome. J Psychopathol Behav Assess. 2010 Jun;32(2):185-192. doi: 10.1007/s10862-009-9151-3. Epub 2009 Jul 24.
PubMed 20421906[8] Tsao, J. C. I., Mystkowski, J. L., Zucker, B. G., & Craske, M. G. (2002). Effects of cognitive-behavioral therapy for panic disorder on comorbid conditions: Replication and extension. Behavior Therapy, 33(4), 493-509. https://doi.org/10.1016/S0005-7894(02)80013-2
Powers MB, Zum Vorde Sive Vording MB, Emmelkamp PM. Acceptance and commitment therapy: a meta-analytic review. Psychother Psychosom. 2009;78(2):73-80. doi: 10.1159/000190790. Epub 2009 Jan 14.
PubMed 19142046[10] Petersen, J. M., Ona, P. Z., & Twohig, M. P. (2022). A Review of Acceptance and Commitment Therapy for Adolescents: Developmental and Contextual Considerations. Cognitive and Behavioral Practice. https://doi.org/10.1016/j.cbpra.2022.08.002
Dalgleish T, Black M, Johnston D, Bevan A. Transdiagnostic approaches to mental health problems: Current status and future directions. J Consult Clin Psychol. 2020 Mar;88(3):179-195. doi: 10.1037/ccp0000482.
PubMed 32068421Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
PubMed 16300724[13] Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (1999). Acceptance and commitment therapy: An experiential approach to behavior change (pp. xvi, 304). Guilford Press.
[14] Hayes, S. C., Pistorello, J., & Levin, M. E. (2012). Acceptance and Commitment Therapy as a Unified Model of Behavior Change. The Counseling Psychologist, 40(7), 976-1002. https://doi.org/10.1177/0011000012460836
[15] Gloster, A. T., Walder, N., Levin, M. E., Twohig, M. P., & Karekla, M. (2020). The empirical status of acceptance and commitment therapy: A review of meta-analyses. Journal of Contextual Behavioral Science, 18, 181-192.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Where We All Meet: ACT as a Conceptual and Therapeutic Transdiagnostic Approach to Adolescents With Different Anxiety Disorders
- ClinicalTrials.gov ID
- NCT05906849
- Acronym / sponsor ID
- 2022.13986.BD
- Keywords
- Acceptance and Commitment Therapy, Transdiagnostic Processes, Psychological Flexibility/Inflexibility, Adolescents, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Jun 2023 (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.
Transdiagnostic approaches have been proposed as more truthfully representing mental health problems. Acceptance and Commitment Therapy (ACT) is a transdiagnostic approach that proposes Psychological Inflexibility/Flexibility (PI/PF) as the root of human suffering/flourishing. ACT has been recognized as conceptually and clinically relevant for adult disorders. However, during adolescence, when anxiety disorders are highly prevalent, the same evidence is scarce. Specifically, methodologically robust designs investigating ACT's efficacy on adolescents' ADs are scarce and mechanisms underlying change during ACT for adolescents with ADs have not been investigated. Therefore, this study aims to adapt, implement, and investigate the efficacy of an online delivered (through videoconference) ACT intervention to adolescents presenting SAD or GAD, thus contributing to amplifying the transdiagnostic application of ACT to these disorders. A Randomized Controlled Trial (RCT) with 3 groups (i.e., Control, GAD intervention, and SAD intervention groups) of adolescents aged between 14 and 18 years old will be conducted. Outcome measurement will be assessed at pre-intervention, post-intervention, and at 3- and 6-month follow-ups. The investigators expect improvements in outcome variables (e.g., anxiety symptoms) at post-treatment for intervention groups. When comparing changes in outcome variables between the control and the intervention groups, improvements are expected only in the groups receiving intervention. Additionally, similar effects on outcome measures are expected in both intervention groups with gains being maintained over time (i.e., at 3- and 6-months follow-up). Finally, changes in PI/PF processes are expected to predict changes in outcome variables in both intervention groups. This RCT will provide valuable insights that can potentially enhance the efficacy of treatment modalities, contributing to improved well-being for adolescents with ADs.
Detailed description
Recently, researchers have increasingly focused on understanding commonalities in psychological processes underlying human suffering and psychopathology [1,2]. This has been driven by multiple factors, namely: high comorbidity among mental health problems [e.g., 3,4]; evidence for within-disorder and between-disorder prediction and cascading effects throughout life [e.g., 5,6]; data suggesting that disorder-specific interventions produce improvements in comorbid disorders [e.g., 7,8]; established efficacy of transdiagnostic interventions in multiple disorders [e.g., 9,10]; and their equivalent efficacy to diagnosis-specific interventions [11]. Taken together, research indicates the presence of shared mechanisms, highlighting the need for treatments to target broader processes. Accordingly, transdiagnostic approaches have emerged as promising frameworks, as they may better reflect the complexity and dimensionality of the human experience and more accurately represent the reality of mental health problems.
Acceptance and Commitment Therapy (ACT) is a transdiagnostic approach to behavior change that proposes Psychological Inflexibility (PI) as the root of human suffering in general, and of mental health disorders in particular [12]. PI is defined as rigid attempts to control, alter or minimize unpleasant internal experiences at the expense of the ability to persist and/or change behavior to pursue chosen values. PI steams from six interrelated processes: Cognitive Fusion, Experiential Avoidance, Attachment to the Conceptualized Self, Dominance of the Conceptualized Past/Feared Future, Lack of Values Clarity and Inaction, Impulsivity or Avoidant Persistence [13]. ACT aims to reverse PI processes by cultivating Psychological Flexibility (PF) which refers to the ability to be in contact with the present moment regardless of unpleasant internal experiences while persisting in value-guided behaviors [14]. PF entails six interrelated processes, opposing each PI processes: Cognitive Defusion, Acceptance, Self as Context, Contact with the Present Moment, Values, and Committed Action [12].
Evidence supports ACT's efficacy in adults with various disorders [e.g.,15, 16] as well as the role of PI/PF components as mechanisms of change following ACT [17]. Some studies support that role in adolescents' mental health [18,19] and promising results suggest ACT's efficacy with this population [e.g.,20]. However, most studies did not consider all PI/PF processes [e.g., 21] and there is a scarcity of methodologically robust designs (e.g., Randomized Controlled Trials; RCTs) investigating ACT interventions in adolescents [e.g.,10]. Because most studies did not include extended follow-ups and adolescence is marked by significant and rapid psychological changes [22], ACT's utility to this age group has not been fully assessed. This seems worrisome considering that between 10 to 20% of adolescents experience mental health problems [23]. In youth, anxiety disorders are the most common disorders [24]. Particularly, Social Anxiety Disorder (SAD) and Generalized Anxiety Disorder (GAD) present significant prevalence rates in adolescents [4,25] both typically presenting a chronic course that may evolve into other mental health disorders in adulthood [6,26]. ACT has been proven effective for SAD and GAD treatment in adults [27,28]. Preliminary findings point to ACT being efficacious for treating anxiety in adolescence [23]. However, few studies examined ACT's efficacy for adolescents' SAD [20,29], and only one included adolescents with GAD [20]. Research on the efficacy of ACT to adolescents' SAD and GAD is largely missing, and mechanisms underlying change have not been reported. Increasing the understanding of the common mechanisms underlying mental health problems in adolescents, and how these mechanisms can be used to sustain efficacious psychological interventions, is a crucial research concern.
Thus, this project intends to amplify the transdiagnostic application of ACT to adolescents presenting SAD and GAD. A RCT will be conducted to explore the efficacy and processes of change of ACT for SAD or GAD, considering adolescents' anxiety symptoms and flourishing as outcomes. The research team will adapt, implement, and investigate the efficacy of an online delivered (videoconference) ACT Intervention to adolescents presenting SAD or GAD via: : 1. Changes in primary (i.e., anxiety symptoms) and secondary (i.e., flourishing and PI/PF processes) outcomes following intervention - significant improvements are expected at post-intervention only in the intervention groups (i.e., SAD intervention and GAD intervention groups), in comparison with a clinical control group; 2. Examining the stability of change over time (i.e., 3- and 6-months follow-up) - improvements are expected to maintain; 3. Comparing the efficacy of the intervention between both intervention groups - Similar effects on outcome measures for both clinical groups are expected; 4. Investigating mechanisms of change following intervention in both intervention groups - Similar findings in both intervention groups are expected, with changes in PI/PF predicting changes in outcome variables.
All procedures involved in this project (described elsewhere in this form) were approved by the Ethics Committee of the Faculty of Psychology and Educational Sciences, University of Coimbra and the General Directorate of Education authorized the data collection protocol to be implemented in school contexts. Informed consent from adolescents and their parents/legal guardians will be required for all potential participants prior to any data collection. Adolescents and their parents/legal guardians will be informed that the participation is voluntary and that they can decline to participate at any time during the project without any negative consequence. Moreover, they will be informed that the confidentiality of responses will be assured in all moments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- To attain this project's aims a longitudinal research will take place. Adolescents presenting SAD or GAD will be randomly allocated to a Control Group (no intervention group), or an Experimental Group (individual intervention group). Adolescents with SAD will be randomly allocated to the control group (n≥13), and to the SAD Experimental Group (n=29). Similarly, adolescents with GAD will be randomly allocated to the control group (n≥13), the to the GAD Experimental Group (n=29). Therefore, the Randomized and Parallel Controlled Trial will include a Control Group (N=29), a SAD (n=29) and a GAD (n=29) Experimental Group.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Group of participants with a main diagnosis of social anxiety disorder (n≥13) or generalized anxiety disorder (n≥13) not subjected to any psychological intervention within the current trial. They will be asked to fill in the self-report protocol at 2 different time points (12 weeks interval) mimicking the pre- and post-intervention assessment moments; these adolescents will be assessed after the second time point and referred to the school psychology services if the difficulties persist. |
| SAD Intervention Group | Experimental | Behavioral: ACT for anxiety disordersGroup of participants with a main diagnosis of social anxiety disorder (n=26) subjected to individual online delivered 12 sessions ACT psychotherapy. Participants pertaining to this group will be assessed at 4 different time points (pre- and post-treatment and at a 3- and 6- month follow-up). |
| GAD Intervention Group | Experimental | Behavioral: ACT for anxiety disordersGroup of participants with a main diagnosis of generalized anxiety disorder (n=26) subjected to individual online delivered 12 sessions ACT psychotherapy. Participants pertaining to this group will be assessed at 4 different time points (pre- and post-treatment and at a 3- and 6- month follow-up). |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy adolescent's sample: No mental health diagnosis;
- Adolescents with SAD sample: Main diagnosis of SAD;
- Adolescents with GAD sample: Main diagnosis of GAD. Note: adolescents presenting both GAD and SAD will be excluded as its inclusion could confound the projects' results and conclusions.
Key exclusion criteria (3 listed)
- Cognitive impairment (assessed through a clinical interview; MINI-KID [37,38]);
- Presence of psychotic symptoms or suicidal ideation (according to the MINI-KID [37,38]);
- Undergoing another treatment (e.g., medication) for a psychiatric condition.
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 |
|---|---|---|
| ACT for anxiety disordersA twelve session Acceptance and Commitment Therapy (ACT) for anxiety disorders, applied individually and remotely (through videoconference) to participants fulfilling inclusion criteria (i.e., participants included in the SAD and GAD Experimental Groups). | Behavioural | GAD Intervention Group, SAD Intervention Group |
Primary outcome
Change in the Social Anxiety and Avoidance Scale for Adolescents
Time frame: Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months
The SAASA consists of 30 items in its adapted version for late adolescents [30]. It intends to assess the degree of anxiety and frequency of avoidance in social situations representative of the most frequent social fears during adolescence. Each item (e.g., "Going to a party given by a colleague") is answered twice, for two subscales - anxiety and avoidance -, on a five-point Likert scale (ranging from 1 = 'none' to 5 = 'very much' for anxiety; and from 1 = 'never' to 5 = 'almost always' for avoidance). Previous psychometric information indicates very good internal consistency values, convergent validity in relation to other measures of anxious and depressive symptoms, and measurement invariance across gender and age [30, 31]
Change in Generalized Anxiety Disorder - 7
Time frame: Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months
The GAD-7 [32,33] is a 7 item self-report scale initially designed to identify probable cases of Generalized Anxiety Disorder (GAD). The GAD-7 assesses Generalized Anxiety Disorder symptoms such as nervousness, uncontrollability of worry, excessive worry, restlessness, difficulty in relaxing and easy irritability. Items (e.g., "Feeling nervous, anxious or on edge") are answered in 4-point Liker scale (ranging from 0='not at all' to 3= 'nearly every day') reporting to the two previous weeks. Higher scores on the GAD-7 represent higher levels of GAD symptoms. Previous psychometric information indicates excellent internal consistency values and divergent validity in relation to measures of quality of life and satisfaction with school [33].
2 secondary outcomes
Change in the Multidimensional Psychological Flexibility Inventory - 24 (short form)
Time frame: Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months
Change in Mental Health Continuum - Short Form - for youth
Time frame: Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Background: PubMed 29057212Levin ME, MacLane C, Daflos S, Seeley J, Hayes SC, Biglan A, Pistorello J. Examining psychological inflexibility as a transdiagnostic process across psychological disorders. J Contextual Behav Sci. 2014 Jul;3(3):155-163. doi: 10.1016/j.jcbs.2014.06.003.
- Background[2] Norton, P. (Ed.). (2017). Transdiagnostic Approaches [Special Issue]. 46. https://doi.org/10.1016/j.janxdis.2017.02.004
- Background: PubMed 15939837Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
- Background: PubMed 34303082Niermann HCM, Voss C, Pieper L, Venz J, Ollmann TM, Beesdo-Baum K. Anxiety disorders among adolescents and young adults: Prevalence and mental health care service utilization in a regional epidemiological study in Germany. J Anxiety Disord. 2021 Oct;83:102453. doi: 10.1016/j.janxdis.2021.102453. Epub 2021 Jul 10.
- Background: PubMed 28861892Asselmann E, Wittchen HU, Lieb R, Beesdo-Baum K. Sociodemographic, clinical, and functional long-term outcomes in adolescents and young adults with mental disorders. Acta Psychiatr Scand. 2018 Jan;137(1):6-17. doi: 10.1111/acps.12792. Epub 2017 Aug 31.
- Background: PubMed 19581568Copeland WE, Shanahan L, Costello EJ, Angold A. Childhood and adolescent psychiatric disorders as predictors of young adult disorders. Arch Gen Psychiatry. 2009 Jul;66(7):764-72. doi: 10.1001/archgenpsychiatry.2009.85.
- Background: PubMed 20421906Allen LB, White KS, Barlow DH, Shear MK, Gorman JM, Woods SW. Cognitive-Behavior Therapy (CBT) for Panic Disorder: Relationship of Anxiety and Depression Comorbidity with Treatment Outcome. J Psychopathol Behav Assess. 2010 Jun;32(2):185-192. doi: 10.1007/s10862-009-9151-3. Epub 2009 Jul 24.
- Background[8] Tsao, J. C. I., Mystkowski, J. L., Zucker, B. G., & Craske, M. G. (2002). Effects of cognitive-behavioral therapy for panic disorder on comorbid conditions: Replication and extension. Behavior Therapy, 33(4), 493-509. https://doi.org/10.1016/S0005-7894(02)80013-2
- Background: PubMed 19142046Powers MB, Zum Vorde Sive Vording MB, Emmelkamp PM. Acceptance and commitment therapy: a meta-analytic review. Psychother Psychosom. 2009;78(2):73-80. doi: 10.1159/000190790. Epub 2009 Jan 14.
- Background[10] Petersen, J. M., Ona, P. Z., & Twohig, M. P. (2022). A Review of Acceptance and Commitment Therapy for Adolescents: Developmental and Contextual Considerations. Cognitive and Behavioral Practice. https://doi.org/10.1016/j.cbpra.2022.08.002
- Background: PubMed 32068421Dalgleish T, Black M, Johnston D, Bevan A. Transdiagnostic approaches to mental health problems: Current status and future directions. J Consult Clin Psychol. 2020 Mar;88(3):179-195. doi: 10.1037/ccp0000482.
- Background: PubMed 16300724Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
- Individual participant dataSharing planned: No
Related trials for Social Anxiety Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
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.
Diana V Figueiredo, M.Sc. contact
Diana V Figueiredo, M.Sc. principal investigator
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), FPCE-UC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT for anxiety disorders in people with Social Anxiety Disorder and Generalized 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?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 14 Jul 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana V Figueiredo, M.Sc. (968441870 ext. +351, diana.v.figueiredo@fpce.uc.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Social Anxiety and Avoidance Scale for Adolescents (time frame: Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months). The study lists 2 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 NCT05906849, which also lists 38 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 14 Jul 2023.