DepressionTAYLOR1NCT01181583
Tailored Internet-delivered Cognitive Behaviour Therapy for Symptoms of Depression and Comorbid Problems
A study testing Tailored Internet-delivered CBT, Non-tailored Internet-delivered CBT and Online discussion group in people with Depression and Anxiety Disorders, run by Linkoeping University at 1 site in Sweden.
Trial summary
The overall aim of this study is to develop and test a tailored Internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group. 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-delivered CBT, Non-tailored Internet-delivered CBT and Online discussion group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteSweden
- Study dates
- Start not givento not given
- 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
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Major Depressive Disorder
- 15 or more on MADRS-S
Who cannot join
- Severe depression (more than 35 on MADRS-S or based on interview)
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Changed medication during the last three months
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Linköping University, Department of Behavioral Sciences and Learning
Linköping
About this study
Official title: Efficacy Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression and Comorbid Problems
The overall aim of this study is to develop and test a tailored Internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group.
Read the detailed description
Internet-delivered cognitive behaviour therapy (CBT) has emerged as a promising way to administer evidence-based psychological treatments. Mild to moderate major depression has previously been found to treatable via the Internet, with the provision that minimal therapist guidance is given. However, previous research has not taken the issue of comorbidity into account. It is well known that major depression often is accompanied by anxiety and in addition the symptom profile in major depression may differ substantially. The idea behind the proposed research is to tailor the Internet intervention according to the symptom profile. By used a large set of treatment modules (text-based) we aim to diagnose and then prescribe modules. In a randomized trial we want to compare this procedure (e.g., tailored CBT) with the standard Internet-delivered CBT. We will also include a control group in the form of a supervised online discussion group who will later receive CBT.
- Conditions
- Depression, Anxiety Disorders
- Being tested
- Tailored Internet-delivered CBT, Non-tailored Internet-delivered CBT, Online discussion group
- 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-delivered CBTBehavioural
This 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 telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
Non-tailored Internet-delivered CBTBehavioural
Specific text-based self-help for depression, which has previously been tested in three previous randomized trials. Anxiety symptoms will not be covered, but insomnia is included as a module together with advice on health.
Online discussion groupBehavioural
Participants take part of an online discussion group which are monitored daily. New discussion topics on depression are introduced every week.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Internet-delivered CBT | Experimental | Not described Receives: Behavioral: Tailored Internet-delivered CBT |
| Non-tailored Internet-delivered CBT | Experimental | Not described Receives: Behavioral: Non-tailored Internet-delivered CBT |
| Online discussion group | Active comparator | Not described Receives: Behavioral: Online discussion group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (BDI)
Measured: One week before the treatment starts
Beck Depression Inventory (BDI)
Measured: Five weeks after treatment started
Beck Depression Inventory (BDI)
Measured: At treatment termination (10 weeks)
Beck Depression Inventory (BDI)
Measured: 6 month after treatment ended
Beck Depression Inventory (BDI)
Measured: 2 years after treatment ended
Secondary outcomes (15)
Beck Anxiety Inventory (BAI)
Measured: One week before the treatment starts
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Measured: One week before the treatment starts
Quality of Life Inventory (QOLI)
Measured: One week before the treatment starts
Beck Anxiety Inventory (BAI)
Measured: Five weeks after treatment started
Beck Anxiety Inventory (BAI)
Measured: At treatment termination (10 weeks)
Beck Anxiety Inventory (BAI)
Measured: 6 month after treatment ended
Beck Anxiety Inventory (BAI)
Measured: 2 years after treatment ended
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Measured: Five weeks after treatment started
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Measured: At treatment termination (10 weeks)
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Measured: 6 month after treatment ended
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Measured: 2 years after treatment ended
Quality of Life Inventory (QOLI)
Measured: Five weeks after treatment started
Quality of Life Inventory (QOLI)
Measured: At treatment termination (10 weeks)
Quality of Life Inventory (QOLI)
Measured: 6 month after treatment ended
Quality of Life Inventory (QOLI)
Measured: 2 years after treatment ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Investigators
- Gerhard Andersson, PhD, Principal investigator, Department of Behavioral Sciences and Learning, Linköping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181583
- Sponsor's protocol ID
- GA-VR-DEP2009-1
- Acronym
- TAYLOR1
- Status last verified
- Dec 2010
- First submitted
- 9 Aug 2010
- Last updated
- 28 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johansson R, Sjoberg E, Sjogren M, Johnsson E, Carlbring P, Andersson T, Rousseau A, Andersson G. Tailored vs. standardized internet-based cognitive behavior therapy for depression and comorbid symptoms: a randomized controlled trial. PLoS One. 2012;7(5):e36905. doi: 10.1371/journal.pone.0036905. Epub 2012 May 15.
PubMed 22615841
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Testing of a Tailored Internet-delivered Cognitive Behaviour Therapy Treatment for Symptoms of Depression and Comorbid Problems
- ClinicalTrials.gov ID
- NCT01181583
- Acronym / sponsor ID
- TAYLOR1 / GA-VR-DEP2009-1
- Conditions
- Depression, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- First posted
- 13 Aug 2010 (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 overall aim of this study is to develop and test a tailored Internet-delivered psychological treatment for patients with mild to moderate major depression and comorbid anxiety symptoms and compare its efficacy to a non-tailored treatment and to an active control group.
Detailed description
Internet-delivered cognitive behaviour therapy (CBT) has emerged as a promising way to administer evidence-based psychological treatments. Mild to moderate major depression has previously been found to treatable via the Internet, with the provision that minimal therapist guidance is given. However, previous research has not taken the issue of comorbidity into account. It is well known that major depression often is accompanied by anxiety and in addition the symptom profile in major depression may differ substantially. The idea behind the proposed research is to tailor the Internet intervention according to the symptom profile. By used a large set of treatment modules (text-based) we aim to diagnose and then prescribe modules. In a randomized trial we want to compare this procedure (e.g., tailored CBT) with the standard Internet-delivered CBT. We will also include a control group in the form of a supervised online discussion group who will later receive CBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tailored Internet-delivered CBT | Experimental | Behavioral: Tailored Internet-delivered CBT |
| Non-tailored Internet-delivered CBT | Experimental | Behavioral: Non-tailored Internet-delivered CBT |
| Online discussion group | Active comparator | Behavioral: Online discussion group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Major Depressive Disorder
- 15 or more on MADRS-S
Key exclusion criteria (3 listed)
- Severe depression (more than 35 on MADRS-S or based on interview)
- Severe psychiatric condition (e.g. psychosis or bipolar disorder)
- Changed medication during the last three months
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-delivered CBTThis 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 telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things. | Behavioural | Tailored Internet-delivered CBT |
| Non-tailored Internet-delivered CBTSpecific text-based self-help for depression, which has previously been tested in three previous randomized trials. Anxiety symptoms will not be covered, but insomnia is included as a module together with advice on health. | Behavioural | Non-tailored Internet-delivered CBT |
| Online discussion groupParticipants take part of an online discussion group which are monitored daily. New discussion topics on depression are introduced every week. | Behavioural | Online discussion group |
Primary outcome
Beck Depression Inventory (BDI)
Time frame: One week before the treatment starts
Beck Depression Inventory (BDI)
Time frame: Five weeks after treatment started
Beck Depression Inventory (BDI)
Time frame: At treatment termination (10 weeks)
Beck Depression Inventory (BDI)
Time frame: 6 month after treatment ended
Beck Depression Inventory (BDI)
Time frame: 2 years after treatment ended
15 secondary outcomes
Beck Anxiety Inventory (BAI)
Time frame: One week before the treatment starts
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time frame: One week before the treatment starts
Quality of Life Inventory (QOLI)
Time frame: One week before the treatment starts
Beck Anxiety Inventory (BAI)
Time frame: Five weeks after treatment started
Beck Anxiety Inventory (BAI)
Time frame: At treatment termination (10 weeks)
Beck Anxiety Inventory (BAI)
Time frame: 6 month after treatment ended
Beck Anxiety Inventory (BAI)
Time frame: 2 years after treatment ended
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time frame: Five weeks after treatment started
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time frame: At treatment termination (10 weeks)
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time frame: 6 month after treatment ended
Montgomery Åsberg Depression Rating Scale Self-report (MADRS-S)
Time frame: 2 years after treatment ended
Quality of Life Inventory (QOLI)
Time frame: Five weeks after treatment started
Quality of Life Inventory (QOLI)
Time frame: At treatment termination (10 weeks)
Quality of Life Inventory (QOLI)
Time frame: 6 month after treatment ended
Quality of Life Inventory (QOLI)
Time frame: 2 years after treatment ended
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 28 Dec 2010.
- Derived from this study: PubMed 22615841Johansson R, Sjoberg E, Sjogren M, Johnsson E, Carlbring P, Andersson T, Rousseau A, Andersson G. Tailored vs. standardized internet-based cognitive behavior therapy for depression and comorbid symptoms: a randomized controlled trial. PLoS One. 2012;7(5):e36905. doi: 10.1371/journal.pone.0036905. Epub 2012 May 15.
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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-delivered CBT, Non-tailored Internet-delivered CBT and Online discussion group 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 2 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 28 Dec 2010. 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 (BDI) (time frame: One week before the treatment starts). The study lists 5 primary outcomes in all. 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 NCT01181583, 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 28 Dec 2010.