Specific PhobiaNCT02306356
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
A study testing Internet-delivered Cognitive Behavior Therapy in people with Specific Phobia and Separation Anxiety, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Specific Phobia, Separation Anxiety, Generalized Anxiety Disorder
- What is being tested?
- Internet-delivered Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2014to Oct 2015
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8-12 years of age
- Fulfilling diagnostic criteria for Generalized Anxiety Disorder (GAD), Separation anxiety, Specific phobia
- Ability to read and write Swedish
- Daily access to the internet
- A parent that is able to co-participate in the treatment
- Participants on psychotropic medication must have been on a stable dose for the last 3 months prior to baseline assessment
Who cannot join
- Diagnosed autism spectrum disorder or Attention-deficit/hyperactivity disorder (ADHD), or principal primary disorder other than GAD, Separation anxiety, Specific phobia
- Acute/severe psychiatric problems such as suicidal risk or severe depression
- Ongoing psychological treatment for anxiety disorders
- Ongoing child custody dispute or abuse in the family
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Child and Adolescent Mental Health Services Östersund
Östersund, Jämtland County, 83183
About this study
An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting. 20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation anxiety, specific phobia and their parents will be recruited from the CAMHS-center in Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and parent-rated anxiety and functioning.
- Being tested
- Internet-delivered Cognitive Behavior Therapy
- Medical subject headings
- Phobia, Specific, Anxiety, Separation, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered Cognitive Behavior TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Behavioral: Internet-delivered Cognitive Behavior Therapy Receives: Behavioral: Internet-delivered Cognitive Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Global Impressions - severity (CGI-S)
Change in CGI-s from baseline to post-treatment and follow-up
Measured: baseline, post-treatment (12 weeks), follow-up (3 months)
Secondary outcomes (10)
Children´s Global Assessment Scale (CGAS
Measured: Baseline, post-treatment (12 weeks), follow-up (3 months)
Spence Child Anxiety Scale C/P (SCAS-C/P)
Measured: Baseline, post-treatment (12 weeks), follow-up (3 months)
Penn State Worry Questionnaire (PSWQ)
Measured: Baseline, post-treatment (12 weeks), follow-up (3 months)
Separation Anxiety Index (SAI)
Measured: Baseline, post-treatment (12 weeks), follow-up (3 months)
Fear Survey Schedule for Children - Revised (FSSC-R)
Measured: Baseline, post-treatment (12 weeks), follow-up (3 months)
Child Sheehan Disability Scale (CSDS)
Measured: Baseline, post-treatment (12 weeks), follow-up (3 months)
Child Depression Inventory (CDI)
Measured: Baseline, post-treatment (12 weeks), follow-up (3 months)
Hospital Anxiety Depression Scale (HAD)
Measured: Baseline, post-treatment (12 weeks), follow-up (3 months)
Client Satisfaction Scale (CSS)
Measured: post-treatment (12 weeks)
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
Measured: Baseline, post-treatment (12 weeks), follow-up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- BUP Östersund
- Responsible party
- Principal investigator, Eva Serlachius, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306356
- Sponsor's protocol ID
- 2014/1225-31/4
- Status last verified
- Jan 2016
- First submitted
- 27 Sep 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
- ClinicalTrials.gov ID
- NCT02306356
- Acronym / sponsor ID
- 2014/1225-31/4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- BUP Östersund
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 3 Dec 2014 (estimated)
- 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.
An open trial will be conducted at the Child and Mental Health Service (CAMHS) unit in the rural county Jämtland in Sweden to test the feasibility and efficacy of Internet-delivered Cognitive Behavior Therapy (ICBT) for children with anxiety disorders in a clinical setting. 20 children with a principal diagnosis of Generalized Anxiety Disorder (GAD), separation anxiety, specific phobia and their parents will be recruited from the CAMHS-center in Östersund. They will receive 12 weeks of therapist-supported ICBT and will be assessed by clinician ratings and child- and parent-reports at baseline, post-treatment and 3 month follow-up. The primary outcome measures the Clinical Global Impressions - Severity scale (CGI-S). Secondary outcome measures include clinician rated global functioning, and child and parent-rated anxiety and functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Behavioral: Internet-delivered Cognitive Behavior TherapyBehavioral: Internet-delivered Cognitive Behavior Therapy |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 8-12 years of age
- Fulfilling diagnostic criteria for Generalized Anxiety Disorder (GAD), Separation anxiety, Specific phobia
- Ability to read and write Swedish
- Daily access to the internet
- A parent that is able to co-participate in the treatment
Key exclusion criteria (4 listed)
- Diagnosed autism spectrum disorder or Attention-deficit/hyperactivity disorder (ADHD), or principal primary disorder other than GAD, Separation anxiety, Specific phobia
- Acute/severe psychiatric problems such as suicidal risk or severe depression
- Ongoing psychological treatment for anxiety disorders
- Ongoing child custody dispute or abuse in the family
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 |
|---|---|---|
| Internet-delivered Cognitive Behavior Therapy | Behavioural | Interventional |
Primary outcome
Change in Clinical Global Impressions - severity (CGI-S)
Time frame: baseline, post-treatment (12 weeks), follow-up (3 months)
Change in CGI-s from baseline to post-treatment and follow-up
10 secondary outcomes
Children´s Global Assessment Scale (CGAS
Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)
Spence Child Anxiety Scale C/P (SCAS-C/P)
Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)
Penn State Worry Questionnaire (PSWQ)
Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)
Separation Anxiety Index (SAI)
Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)
Fear Survey Schedule for Children - Revised (FSSC-R)
Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)
Child Sheehan Disability Scale (CSDS)
Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)
Child Depression Inventory (CDI)
Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)
Hospital Anxiety Depression Scale (HAD)
Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)
Client Satisfaction Scale (CSS)
Time frame: post-treatment (12 weeks)
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
Time frame: Baseline, post-treatment (12 weeks), follow-up (3 months)
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 20 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered Cognitive Behavior Therapy in people with Specific Phobia and Separation Anxiety, run by Karolinska Institutet 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 6 inclusion and 4 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 20 Jan 2016. 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?
Change in Clinical Global Impressions - severity (CGI-S) (time frame: baseline, post-treatment (12 weeks), follow-up (3 months)). 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 20 Jan 2016.