AnxietyNCT03441490
Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety
A study testing Guided-ICBT for adolescents with anxiety, Guided-ICBT with chat and Guided-ICBT with learning support in people with Anxiety, run by Linkoeping University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Guided-ICBT for adolescents with anxiety, Guided-ICBT with chat and Guided-ICBT with learning support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 8 Feb 2018to 20 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be between the ages of 15-19 years old
- Have symptoms of anxiety, anxiety disorder
Who cannot join
- Suicidal ideation
- Alcohol addiction
- other major primary psychiatric disorder
- Ongoing psychological treatment
- recent (during last 4 weeks) change in psychiatric medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Anxiety
- Being tested
- Guided-ICBT for adolescents with anxiety, Guided-ICBT with chat, Guided-ICBT with learning support, Guided-ICBT with learning support and chat
- Keywords
- Learning Support, Chat, Adolescents
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided-ICBT for adolescents with anxietyBehavioural
Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.
Guided-ICBT with chatBehavioural
Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.
Guided-ICBT with learning supportBehavioural
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.
Guided-ICBT with learning support and chatBehavioural
Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ICBT standard | Active comparator | Internet-based cognitive behavioural therapy with therapeutic guidance through mail Receives: Behavioral: Guided-ICBT for adolescents with anxiety |
| ICBT chat | Experimental | Internet-based cognitive behavioural therapy with therapeutic guidance through chat Receives: Behavioral: Guided-ICBT with chat |
| ICBT learning support | Experimental | Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail Receives: Behavioral: Guided-ICBT with learning support |
| ICBT with learning support and chat | Experimental | Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat Receives: Behavioral: Guided-ICBT with learning support and chat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory (BAI)
Measures clinical anxiety. Change from baseline in symptoms two weeks post treatment and at 12 months post treatment.
Measured: 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.
Measured: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start8 Feb 2018
- Primary completion20 May 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441490
- Sponsor's protocol ID
- Dnr 2017/489-31.
- Status last verified
- Aug 2018
- First submitted
- 14 Feb 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavioural Therapy for Adolescents With Anxiety: A Factorial Design
- ClinicalTrials.gov ID
- NCT03441490
- Acronym / sponsor ID
- Dnr 2017/489-31.
- Conditions
- Anxiety
- Keywords
- Learning Support, Chat, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| ICBT standard | Active comparator | Behavioral: Guided-ICBT for adolescents with anxietyInternet-based cognitive behavioural therapy with therapeutic guidance through mail |
| ICBT chat | Experimental | Behavioral: Guided-ICBT with chatInternet-based cognitive behavioural therapy with therapeutic guidance through chat |
| ICBT learning support | Experimental | Behavioral: Guided-ICBT with learning supportInternet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail |
| ICBT with learning support and chat | Experimental | Behavioral: Guided-ICBT with learning support and chatInternet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Be between the ages of 15-19 years old
- Have symptoms of anxiety, anxiety disorder
Key exclusion criteria (5 listed)
- Suicidal ideation
- Alcohol addiction
- other major primary psychiatric disorder
- Ongoing psychological treatment
- recent (during last 4 weeks) change in psychiatric medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided-ICBT for adolescents with anxietyInternet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks. | Behavioural | ICBT standard |
| Guided-ICBT with chatInternet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks. | Behavioural | ICBT chat |
| Guided-ICBT with learning supportInternet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks. | Behavioural | ICBT learning support |
| Guided-ICBT with learning support and chatInternet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks. | Behavioural | ICBT with learning support and chat |
Primary outcome
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.
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.
8 secondary outcomes
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
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.
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
Agoraphobic Cognitions Questionnaire (ACQ)
Time frame: 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
Rosenberg Self-Esteem Scale (RSES)
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Andersson, PhD principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided-ICBT for adolescents with anxiety, Guided-ICBT with chat and Guided-ICBT with learning support in people with Anxiety, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Anxiety Inventory (BAI) (time frame: Two weeks pre treatment, two weeks post treatment, six months post treatment and 12 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.