Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety
8. august 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Linköping, Sverige
- Linköping University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
15 år til 19 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: ICBT standard
Internet-based cognitive behavioural therapy with therapeutic guidance through mail
|
Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.
|
|
Eksperimentel: ICBT chat
Internet-based cognitive behavioural therapy with therapeutic guidance through chat
|
Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.
|
|
Eksperimentel: ICBT learning support
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail
|
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.
|
|
Eksperimentel: ICBT with learning support and chat
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat
|
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Beck Anxiety Inventory (BAI)
Tidsramme: 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.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
|
Beck Depression Inventory - II (BDI-II)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Penn State Worry Questionnaire for Children (PSWQ - C)
Tidsramme: 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
|
|
Generalised Anxiety Disorder (GAD-7)
Tidsramme: 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.
|
Measures severity of generalised anxiety.
|
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.
|
|
Mini-Social Phobia Inventory (MINI-SPIN)
Tidsramme: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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)
Tidsramme: 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.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
|
Satisfaction With Life Scale (SWLS)
Tidsramme: 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
|
|
Rosenberg Self-Esteem Scale (RSES)
Tidsramme: 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
|
|
Alcohol Use Disorders Identification Test (AUDIT)
Tidsramme: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
Measures alcohol consumption, drinking behaviors, and alcohol-related problems.
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
|
|
Knowledge of CBT strategies (developed by the research group)
Tidsramme: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. februar 2018
Primær færdiggørelse (Faktiske)
20. maj 2018
Studieafslutning (Faktiske)
20. juni 2018
Datoer for studieregistrering
Først indsendt
14. februar 2018
Først indsendt, der opfyldte QC-kriterier
20. februar 2018
Først opslået (Faktiske)
22. februar 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Dnr 2017/489-31.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Guided-ICBT for adolescents with anxiety
-
University of ReginaAfsluttetDepression | Angst | Kronisk sygdomCanada
-
Assiut UniversityAfsluttet