Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Anxiety

Intervention / Treatment
-----------------
* Behavioral: Guided-ICBT for adolescents with anxiety
* Behavioral: Guided-ICBT with chat
* Behavioral: Guided-ICBT with learning support
* Behavioral: Guided-ICBT with learning support and chat


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Design is a two-by-two factorial randomized trial with four intervention groups: 1, ICBT with therapeutic guidance through mail. 2, ICBT with therapeutic guidance through chat. 3, ICBT with learning support and terapeutic guidance through mail. 4. ICBT with learning support and terapeutic guidance through chat.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICBT standard<br>Internet-based cognitive behavioural therapy with therapeutic guidance through mail | Behavioral: Guided-ICBT for adolescents with anxiety<br>* Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.<br>|
| Experimental: ICBT chat<br>Internet-based cognitive behavioural therapy with therapeutic guidance through chat | Behavioral: Guided-ICBT with chat<br>* Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.<br>|
| Experimental: ICBT learning support<br>Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail | Behavioral: Guided-ICBT with learning support<br>* Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.<br>|
| Experimental: ICBT with learning support and chat<br>Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat | Behavioral: Guided-ICBT with learning support and chat<br>* Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Anxiety Inventory (BAI) | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment | 
| Generalised Anxiety Disorder (GAD-7) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Learning Support, Chat, Adolescents