About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Parallel
Treatments tested in this trial
ACT for anxiety disorders
BehavioralA 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).
Treatment groups
Trial outcomes
Primary outcomes
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 \[30, 31\]
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 \[33\].
Secondary outcomes
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.
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 \[36\] .
Sponsors and contacts
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University of Coimbra
Lead sponsor
Foundation for Science and Technology, Portugal
Collaborator