Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety
8 augusti 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
120
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Linköping, Sverige
- Linköping University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
15 år till 19 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Aktiv komparator: 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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Experimentell: 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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Experimentell: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Beck Anxiety Inventory (BAI)
Tidsram: 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)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Penn State Worry Questionnaire for Children (PSWQ - C)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
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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.
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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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Rosenberg Self-Esteem Scale (RSES)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 februari 2018
Primärt slutförande (Faktisk)
20 maj 2018
Avslutad studie (Faktisk)
20 juni 2018
Studieregistreringsdatum
Först inskickad
14 februari 2018
Först inskickad som uppfyllde QC-kriterierna
20 februari 2018
Första postat (Faktisk)
22 februari 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 augusti 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 augusti 2018
Senast verifierad
1 augusti 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Dnr 2017/489-31.
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Kliniska prövningar på Ångest
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Szeged UniversityAvslutadCoping färdigheter | Humör | Covid-19 pandemi | Psykologisk stress | Subjektivt hälsoklagomål | Frågeformulärdesigner | Tvådelad skala för generaliserat ångestsyndrom | Patienthälsa frågeformulär Anxiety and Depression Scale | HälsostatusindexUngern