Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441490
• Other study ID #: Dnr 2017/489-31.
• Status: Completed
• Phase: N/A
• Start date: February 8, 2018
• Est. completion date: June 20, 2018

Study information

• Verified date: August 2018
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 20, 2018
• Est. primary completion date: May 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Guided-ICBT for adolescents with anxiety
Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.
• Guided-ICBT with chat
Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.
• Guided-ICBT with learning support
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.
• Guided-ICBT with learning support and chat
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.

Locations

Country	Name	City	State
Sweden	Linköping University	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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