Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety
8 agosto 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
120
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Linköping, Svezia
- Linköping University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 15 anni a 19 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Beck Anxiety Inventory (BAI)
Lasso di tempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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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)
Lasso di tempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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Measures clinical depression.
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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Penn State Worry Questionnaire for Children (PSWQ - C)
Lasso di tempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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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.
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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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Generalised Anxiety Disorder (GAD-7)
Lasso di tempo: 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)
Lasso di tempo: 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.
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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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Agoraphobic Cognitions Questionnaire (ACQ)
Lasso di tempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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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)
Lasso di tempo: 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)
Lasso di tempo: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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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.
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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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Alcohol Use Disorders Identification Test (AUDIT)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
8 febbraio 2018
Completamento primario (Effettivo)
20 maggio 2018
Completamento dello studio (Effettivo)
20 giugno 2018
Date di iscrizione allo studio
Primo inviato
14 febbraio 2018
Primo inviato che soddisfa i criteri di controllo qualità
20 febbraio 2018
Primo Inserito (Effettivo)
22 febbraio 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 agosto 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 agosto 2018
Ultimo verificato
1 agosto 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Dnr 2017/489-31.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
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