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Completed

NCT Number: NCT03441490

Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety

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.

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Key information

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping University

Linköping, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guided-ICBT for adolescents with anxiety

Behavioral

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

Guided-ICBT with chat

Behavioral

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

Guided-ICBT with learning support

Behavioral

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

Guided-ICBT with learning support and chat

Behavioral

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

Primary outcomes

  1. Beck Anxiety Inventory (BAI)

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Generalised Anxiety Disorder (GAD-7)

    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.

    Measures severity of generalised anxiety.

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

    Time frame: 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.

  4. Agoraphobic Cognitions Questionnaire (ACQ)

    Time frame: 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.

  5. Satisfaction With Life Scale (SWLS)

    Time frame: 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.

  6. Rosenberg Self-Esteem Scale (RSES)

    Time frame: 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.

  7. Alcohol Use Disorders Identification Test (AUDIT)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety: A Factorial Design

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 22, 2018
Registry last updated
Aug 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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