Where We All Meet: ACT Approach to Adolescents Anxiety Disorders

Sponsor

University of Coimbra (Other)

Overall Status

Recruiting

CT.gov ID

NCT05906849

Collaborator

Foundation for Science and Technology, Portugal (Other)

Enrollment

Location

Arms

44.9

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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. We 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.

Condition or Disease	Intervention/Treatment	Phase
Social Anxiety Disorder Generalized Anxiety Disorder	Behavioral: ACT for anxiety disorders	N/A

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. We 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

Study Type:

Interventional

Anticipated Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Where We All Meet: ACT as a Conceptual and Therapeutic Transdiagnostic Approach to Adolescents With Different Anxiety Disorders

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group 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.
Experimental: SAD Intervention Group 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).	Behavioral: ACT for anxiety disorders 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).
Experimental: GAD Intervention Group 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).	Behavioral: ACT for anxiety disorders 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).

Arm

Intervention/Treatment

No Intervention: Control Group

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.

Experimental: SAD Intervention Group

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).

Behavioral: ACT for anxiety disorders

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).

Experimental: GAD Intervention Group

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).

Behavioral: ACT for anxiety disorders

Outcome Measures

Primary Outcome Measures

Change in the Social Anxiety and Avoidance Scale for Adolescents [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 [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].

Secondary Outcome Measures

Change in the Multidimensional Psychological Flexibility Inventory - 24 (short form) [Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months]
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.
Change in Mental Health Continuum - Short Form - for youth [Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months]
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] .

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra	Coimbra		Portugal

Sponsors and Collaborators

University of Coimbra
Foundation for Science and Technology, Portugal

Investigators

Principal Investigator: Diana V Figueiredo, M.Sc., Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), FPCE-UC