- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03441490
Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety
August 8, 2018 updated by: 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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Linköping, Sweden
- Linköping University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ICBT standard
Internet-based cognitive behavioural therapy with therapeutic guidance through mail
|
Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.
|
Experimental: ICBT chat
Internet-based cognitive behavioural therapy with therapeutic guidance through chat
|
Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.
|
Experimental: 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.
|
Experimental: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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.
|
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)
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.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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.
|
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)
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.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
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.
|
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)
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.
|
Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 8, 2018
Primary Completion (Actual)
May 20, 2018
Study Completion (Actual)
June 20, 2018
Study Registration Dates
First Submitted
February 14, 2018
First Submitted That Met QC Criteria
February 20, 2018
First Posted (Actual)
February 22, 2018
Study Record Updates
Last Update Posted (Actual)
August 9, 2018
Last Update Submitted That Met QC Criteria
August 8, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 2017/489-31.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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