DepressionNCT02363205
Internet-Delivered Cognitive Behaviour Therapy for Adolescent Depression
A study testing Tailored Internet-administrated CBT-Treatment in people with Depression and Anxiety, run by Linkoeping University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and comorbid anxiety symptoms. Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Tailored Internet-administrated CBT-Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2015to Dec 2017
- 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 depression, major depression
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: Guided Internet-Delivered and Tailored Cognitive Behaviour Therapy for Adolescents With Depression: a Randomized Controlled Trial
The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and comorbid anxiety symptoms.
Read the detailed description
As above
- Conditions
- Depression, Anxiety
- Being tested
- Tailored Internet-administrated CBT-Treatment
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Internet-administrated CBT-TreatmentBehavioural
Guided internet-delivered CBT with chat sessions
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Weekly check-up |
| internet-delivered CBT | Experimental | Tailored Internet-administrated CBT-Treatment Receives: Behavioral: Tailored Internet-administrated CBT-Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory
Change from baseline to post treatment, six months and 12 months post treatment.
Measured: Baseline, post treatment, 6 months- and 12 months post treatment
Secondary outcomes (7)
Beck Anxiety Inventory (BAI)
Change from baseline to post treatment, six months and 12 months post treatment.
Measured: Baseline, post treatment, 6 months- and 12 months post treatment
Social Interaction Anxiety Scale (SIAS)
Change from baseline to post treatment, six months and 12 months post treatment.
Measured: Baseline, post treatment, 6 months- and 12 months post treatment
The General Self-Efficacy Scale (GSE)
Change from baseline to post treatment, six months and 12 months post treatment.
Measured: Baseline, post treatment, 6 months- and 12 months post treatment
Subscale Life activites, WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Change from baseline to post treatment, six months and 12 months post treatment.
Measured: Baseline, post treatment, 6 months- and 12 months post treatment
Knowledge of CBT strategies (developed by the research group)
Change from baseline to post treatment, six months and 12 months post treatment.
Measured: Baseline, post treatment, 6 months- and 12 months post treatment
Patient Health Questionnaire (PHQ)
Change from baseline to post treatment
Measured: Baseline, post treatment, 6 months- and 12 months post treatment
The Mood and Feelings Questionnaire (MFQ)
Change from baseline to post treatment, six months and 12 months post treatment.
Measured: Baseline, post treatment, 6 months- 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 posted13 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363205
- Sponsor's protocol ID
- 2014/427-31
- Status last verified
- Dec 2023
- First submitted
- 9 Feb 2015
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Topooco N, Bylehn S, Dahlstrom Nysater E, Holmlund J, Lindegaard J, Johansson S, Aberg L, Bergman Nordgren L, Zetterqvist M, Andersson G. Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 1;21(11):e13393. doi: 10.2196/13393.
PubMed 31682572
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Internet-Delivered and Tailored Cognitive Behaviour Therapy for Adolescents With Depression: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02363205
- Acronym / sponsor ID
- 2014/427-31
- Conditions
- Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Feb 2015 (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.
The purpose of this study is to determine whether tailored internet-administrated cognitive behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and comorbid anxiety symptoms.
Detailed description
As above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Weekly check-up |
| internet-delivered CBT | Experimental | Behavioral: Tailored Internet-administrated CBT-TreatmentTailored Internet-administrated CBT-Treatment |
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 depression, major depression
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 |
|---|---|---|
| Tailored Internet-administrated CBT-TreatmentGuided internet-delivered CBT with chat sessions | Behavioural | internet-delivered CBT |
Primary outcome
Beck Depression Inventory
Time frame: Baseline, post treatment, 6 months- and 12 months post treatment
Change from baseline to post treatment, six months and 12 months post treatment.
7 secondary outcomes
Beck Anxiety Inventory (BAI)
Time frame: Baseline, post treatment, 6 months- and 12 months post treatment
Social Interaction Anxiety Scale (SIAS)
Time frame: Baseline, post treatment, 6 months- and 12 months post treatment
The General Self-Efficacy Scale (GSE)
Time frame: Baseline, post treatment, 6 months- and 12 months post treatment
Subscale Life activites, WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline, post treatment, 6 months- and 12 months post treatment
Knowledge of CBT strategies (developed by the research group)
Time frame: Baseline, post treatment, 6 months- and 12 months post treatment
Patient Health Questionnaire (PHQ)
Time frame: Baseline, post treatment, 6 months- and 12 months post treatment
The Mood and Feelings Questionnaire (MFQ)
Time frame: Baseline, post treatment, 6 months- 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 11 Dec 2023.
- Derived from this study: PubMed 31682572Topooco N, Bylehn S, Dahlstrom Nysater E, Holmlund J, Lindegaard J, Johansson S, Aberg L, Bergman Nordgren L, Zetterqvist M, Andersson G. Evaluating the Efficacy of Internet-Delivered Cognitive Behavioral Therapy Blended With Synchronous Chat Sessions to Treat Adolescent Depression: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 1;21(11):e13393. doi: 10.2196/13393.
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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 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 Tailored Internet-administrated CBT-Treatment in people with Depression and 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 11 Dec 2023. 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 Depression Inventory (time frame: Baseline, post treatment, 6 months- and 12 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02363205, which also lists 1 linked publication.
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 11 Dec 2023.