Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety
8 août 2018 mis à jour par: Gerhard Andersson, Linkoeping University
Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety: A Factorial Design
The purpose of this study is to evaluate the effects of learning support and chat on treatment outcome in internet-administrated cognitive behaviour therapy (ICBT) for adolescents with anxiety.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
The study is set up as a factorial design with two independent variables: 1: Learning support and 2: chat-sessions in real time.
The intervention tested is based on cognitive behavior therapy delivered over the internet via a secure treatment platform.
Participants in the study are recruited from the general public via social media.
The intervention is in Swedish.
Type d'étude
Interventionnel
Inscription (Réel)
120
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Linköping, Suède
- Linköping University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
15 ans à 19 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Be between the ages of 15-19 years old
- Have symptoms of anxiety, anxiety disorder
Exclusion Criteria:
- Suicidal ideation
- Alcohol addiction
- other major primary psychiatric disorder
- Ongoing psychological treatment
- recent (during last 4 weeks) change in psychiatric medication
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: ICBT standard
Internet-based cognitive behavioural therapy with therapeutic guidance through mail
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Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.
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Expérimental: ICBT chat
Internet-based cognitive behavioural therapy with therapeutic guidance through chat
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Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.
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Expérimental: ICBT learning support
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail
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Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.
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Expérimental: ICBT with learning support and chat
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat
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Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Beck Anxiety Inventory (BAI)
Délai: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
Measures clinical anxiety.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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Beck Depression Inventory - II (BDI-II)
Délai: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
Measures clinical depression.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Penn State Worry Questionnaire for Children (PSWQ - C)
Délai: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
Measures the tendency of youth to engage in excessive, generalized and uncontrollable worry.
Respondents rates each item on a 4-point Likert scale consisting of never (0), sometimes (1), often (2) and always (3).
The scores from each item are summed together to yield a total score that ranges from 0-42, with higher scores reflecting higher levels of worry.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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Generalised Anxiety Disorder (GAD-7)
Délai: First week of treatment and then once a week during the treatment-period, two weeks post treatment, six months post treatment and 12 months post treatment.
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Measures severity of generalised anxiety.
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First week of treatment and then once a week during the treatment-period, two weeks post treatment, six months post treatment and 12 months post treatment.
|
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Mini-Social Phobia Inventory (MINI-SPIN)
Délai: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Measures clinical social phobia.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
|
Agoraphobic Cognitions Questionnaire (ACQ)
Délai: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
Measures fearful cognitions associated with panic attacks and agoraphobia.
The ACQ consists of 14 items which will be scored as a total scale in this study.
worry.
Respondents rates each item on a 5-point Likert scale consisting of never (1), Thought never occurs (2), Thought rarely occurs (3) Thought occurs during half of the times when I am nervous (4) Thought usually occurs (5) Thought always occurs when I am nervous.
ACQ can be divided into two subscales: Loss of Control and Physical Concerns.
Each of the subscales consists of 7 items.The total scores (or the subscales) are calculated by averaging the responses to the individual items composing that score.
Higher scores indicates higher levels of fearful cognitions.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Satisfaction With Life Scale (SWLS)
Délai: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
Measures global cognitive judgements of one's life satisfacation as a whole, on a 5-item scale.
Respondants rates how much they agree or disagree on a 7-pont scale ranging from (7) strongly agree to (1) strongly disagree, where higher scores indicates higher levels of life satisfaction.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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Rosenberg Self-Esteem Scale (RSES)
Délai: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
Evaluates individual self-esteem.
The scale is a ten item Likert scale with items answered on a four point scale, from (0) strongly agree to strongly disagree (3), where higher scores indicates higher self-esteem.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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Alcohol Use Disorders Identification Test (AUDIT)
Délai: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Measures alcohol consumption, drinking behaviors, and alcohol-related problems.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Knowledge of CBT strategies (developed by the research group)
Délai: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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A brief 16-item questionnaire that measures explicit, declarative knowledge about core CBT-principles and therapeutic points.
Higher scores indicates more knowledge.
Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
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Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
8 février 2018
Achèvement primaire (Réel)
20 mai 2018
Achèvement de l'étude (Réel)
20 juin 2018
Dates d'inscription aux études
Première soumission
14 février 2018
Première soumission répondant aux critères de contrôle qualité
20 février 2018
Première publication (Réel)
22 février 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
9 août 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 août 2018
Dernière vérification
1 août 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Dnr 2017/489-31.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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