Where We All Meet: ACT Approach to Adolescents Anxiety Disorders

NCT05906849 | Recruiting

• 1 other identifier: 2022.13986.BD
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder; Generalized Anxiety Disorder

Keywords

Acceptance and Commitment Therapy; Transdiagnostic Processes; Psychological Flexibility/Inflexibility; Adolescents; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• 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 \[30, 31\]

  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 \[33\].

  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)

  Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months

• Change in Mental Health Continuum - Short Form - for youth

  Baseline, Week 12, Follow-Up 3 Months and Follow-Up 6 Months

Study Arms (3)

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).

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).

Behavioral: ACT for anxiety disorders

Interventions

ACT for anxiety disorders 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; SAD Intervention Group

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy adolescent's sample: No mental health diagnosis;
• Adolescents with SAD sample: Main diagnosis of SAD;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Coimbra: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

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

Coimbra, Portugal

RECRUITING

Related Publications (38)

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MeSH Terms

Conditions

Phobia, Social; Generalized Anxiety Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders

Study Officials

• Diana V Figueiredo, M.Sc.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana V Figueiredo, M.Sc.

CONTACT

968441870; diana.v.figueiredo@fpce.uc.pt

Diana V Figueiredo, M.Sc.

CONTACT

diana.v.figueiredo@fpce.uc.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.Sc.

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 18, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)