Where We All Meet: ACT Approach to Adolescents Anxiety Disorders

NCT ID: NCT05906849

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-09-30

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. 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.

Conditions

Social Anxiety Disorder; Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

ACT for anxiety disorders

Intervention Type: BEHAVIORAL

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).

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).

Group Type: EXPERIMENTAL

ACT for anxiety disorders

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

1. Cognitive impairment (assessed through a clinical interview; MINI-KID [37,38]);

2. Presence of psychotic symptoms or suicidal ideation (according to the MINI-KID [37,38]);

3. Undergoing another treatment (e.g., medication) for a psychiatric condition.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation for Science and Technology, Portugal

OTHER

Sponsor Role: collaborator

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Diana Vieira Figueiredo

M.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diana V Figueiredo, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), FPCE-UC

Locations

Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences - University of Coimbra

Coimbra, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Diana V Figueiredo, M.Sc.

Role: CONTACT

diana.v.figueiredo@fpce.uc.pt

968441870 ext. +351

Diana V Figueiredo, M.Sc.

Role: CONTACT

diana.v.figueiredo@fpce.uc.pt

Facility Contacts

Diana V Figueiredo

Role: primary

diana.v.figueiredo@fpce.uc.pt

968441870 ext. +351

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Other Identifiers

2022.13986.BD

Identifier Type: -

Identifier Source: org_study_id