DepressionTAYLOR2NCT01591720
Tailored Internet-delivered Cognitive Behaviour Therapy in Primary Care
A study testing Tailored Internet-based CBT for depression and anxiety in people with Depression and Anxiety Disorders, run by Linkoeping University at 1 site in Sweden.
Trial summary
A tailored Internet-based cognitive-behavioural intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained. Significant within-group effects are expected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety Disorders
- What is being tested?
- Tailored Internet-based CBT for depression and anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Aug 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of depression and anxiety
Who cannot join
- Severe depression (based on interview)
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Suicidal (measured in diagnostic interview)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Linköping University, Department of Behavioral Sciences and Learning
Linköping, 58183
About this study
Official title: Effectiveness Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression, Anxiety and Comorbid Problems
A tailored Internet-based cognitive-behavioural intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained. Significant within-group effects are expected.
Read the detailed description
This Internet-based cognitive-behavioural therapy intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
The intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained.
- Conditions
- Depression, Anxiety Disorders
- Being tested
- Tailored Internet-based CBT for depression and anxiety
- 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-based CBT for depression and anxietyBehavioural
This Internet-based CBT intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Internet-delivered CBT | Experimental | The intervention is delivered within a primary care clinic. Receives: Behavioral: Tailored Internet-based CBT for depression and anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire 9 (PHQ-9)
Measured: 2 weeks before treatment starts
Patient Health Questionnaire 9 (PHQ-9)
Measured: Weekly measures during treatment (for up to 16 weeks)
Patient Health Questionnaire 9 (PHQ-9)
Measured: At treatment termination (after a maximum of 16 weeks)
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Measured: 2 weeks before treatment starts
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Measured: Weekly measures during treatment (for up to 16 weeks)
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Measured: At treatment termination (after a maximum of 16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 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, Department of Behavioral Sciences and Learning, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591720
- Sponsor's protocol ID
- GA-VR-DEP-2
- Acronym
- TAYLOR2
- Status last verified
- May 2012
- First submitted
- 18 Apr 2012
- Last updated
- 4 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression, Anxiety and Comorbid Problems
- ClinicalTrials.gov ID
- NCT01591720
- Acronym / sponsor ID
- TAYLOR2 / GA-VR-DEP-2
- Conditions
- Depression, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 4 May 2012 (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.
A tailored Internet-based cognitive-behavioural intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained. Significant within-group effects are expected.
Detailed description
This Internet-based cognitive-behavioural therapy intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
The intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailored Internet-delivered CBT | Experimental | Behavioral: Tailored Internet-based CBT for depression and anxietyThe intervention is delivered within a primary care clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptoms of depression and anxiety
Key exclusion criteria (3 listed)
- Severe depression (based on interview)
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Suicidal (measured in diagnostic interview)
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-based CBT for depression and anxietyThis Internet-based CBT intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things. | Behavioural | Tailored Internet-delivered CBT |
Primary outcome
Patient Health Questionnaire 9 (PHQ-9)
Time frame: 2 weeks before treatment starts
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Weekly measures during treatment (for up to 16 weeks)
Patient Health Questionnaire 9 (PHQ-9)
Time frame: At treatment termination (after a maximum of 16 weeks)
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Time frame: 2 weeks before treatment starts
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Time frame: Weekly measures during treatment (for up to 16 weeks)
Generalised Anxiety Disorder Assessment 7 (GAD-7)
Time frame: At treatment termination (after a maximum of 16 weeks)
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 4 May 2012.
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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
Department of Behavioral Sciences and Learning, Linköping 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-based CBT for depression and anxiety in people with Depression and Anxiety Disorders, 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 1 inclusion and 3 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 4 May 2012. 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?
Patient Health Questionnaire 9 (PHQ-9) (time frame: 2 weeks before treatment starts). The study lists 6 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 4 May 2012.