ClinicalTrials.gg
CompletedNCT03441490Updated Aug 9, 2018

Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety

An interventional study of Guided-ICBT for adolescents with anxiety and Guided-ICBT with chat in Anxiety, sponsored by Linkoeping University. Completed at 1 site in Sweden. Open to participants aged 15 Years to 19 Years. Per ClinicalTrials.gov, last updated 2018-08-09.

Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
15 Years to 19 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Anxiety

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Keywords

  • Learning Support
  • Chat
  • Adolescents
03

In context

Anxiety Disorders

5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

This study's enrollment of 120 is above the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Linkoeping University is the lead sponsor of 193 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be between the ages of 15-19 years old
  • Have symptoms of anxiety, anxiety disorder

Exclusion criteria

Exclusion Criteria:

  • Suicidal ideation
  • Alcohol addiction
  • other major primary psychiatric disorder
  • Ongoing psychological treatment
  • recent (during last 4 weeks) change in psychiatric medication
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    ICBT standard

    Internet-based cognitive behavioural therapy with therapeutic guidance through mail

    Behavioral: Guided-ICBT for adolescents with anxiety

  • Experimental
    ICBT chat

    Internet-based cognitive behavioural therapy with therapeutic guidance through chat

    Behavioral: Guided-ICBT with chat

  • Experimental
    ICBT learning support

    Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail

    Behavioral: Guided-ICBT with learning support

  • Experimental
    ICBT with learning support and chat

    Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat

    Behavioral: Guided-ICBT with learning support and chat

Interventions

  • BehavioralGuided-ICBT for adolescents with anxiety

    Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.

  • BehavioralGuided-ICBT with chat

    Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.

  • BehavioralGuided-ICBT with learning support

    Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.

  • BehavioralGuided-ICBT with learning support and chat

    Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.

06

What researchers measure

Primary outcomes

  1. Beck Anxiety Inventory (BAI)

    Measures clinical anxiety. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.

    Time frame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  2. Beck Depression Inventory - II (BDI-II)

    Measures clinical depression. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.

    Time frame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

Secondary outcomes

  1. Penn State Worry Questionnaire for Children (PSWQ - C)

    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.

    Time frame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  2. Generalised Anxiety Disorder (GAD-7)

    Measures severity of generalised anxiety.

    Time frame: 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.

  3. Mini-Social Phobia Inventory (MINI-SPIN)

    Measures clinical social phobia. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.

    Time frame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  4. Agoraphobic Cognitions Questionnaire (ACQ)

    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.

    Time frame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  5. Satisfaction With Life Scale (SWLS)

    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.

    Time frame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  6. Rosenberg Self-Esteem Scale (RSES)

    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.

    Time frame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  7. Alcohol Use Disorders Identification Test (AUDIT)

    Measures alcohol consumption, drinking behaviors, and alcohol-related problems. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.

    Time frame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

  8. Knowledge of CBT strategies (developed by the research group)

    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.

    Time frame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment

07

Study locations

1 site
  • Linköping University
    Linköping, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03441490
Responsible party
Gerhard Andersson (professor Gerhard Andersson, Linkoeping University) — Principal investigator
First posted
Feb 22, 2018
Start date
Feb 8, 2018
Primary completion
May 20, 2018
Completion
Jun 20, 2018
Last update
Aug 9, 2018

Study contacts

Gerhard Andersson, PhD
principal investigator · Linkoeping University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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