Generalized Anxiety DisorderNCT01312116
Psychodynamic Internet Treatment Versus Cognitive Behavioral Therapy (CBT) for Generalized Anxiety Disorder
A study testing iCBT and iPDT in people with Generalized Anxiety Disorder, run by Linkoeping University at 1 site in Sweden.
Trial summary
The objective is to test if Internet-delivered cognitive behavior therapy (iCBT) or Internet-delivered psychodynamic therapy (iPDT) performs better for a population with generalized anxiety disorder (GAD), compared to a wait-list control condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- iCBT and iPDT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2009to Dec 2010
- 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
- fulfill the diagnostic criteria for GAD according to DSM-IV
- have access to the Internet
- have good knowledge of the Swedish language
Who cannot join
- recent (during last 6 weeks) change in psychiatric medication
- presently in any other psychological treatment
- severe depression
- suicidal ideation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychodynamic Versus Cognitive Behavioral Internet-Delivered Guided Self-help for Generalized Anxiety Disorder: A Randomized Controlled Trial
The objective is to test if Internet-delivered cognitive behavior therapy (iCBT) or Internet-delivered psychodynamic therapy (iPDT) performs better for a population with generalized anxiety disorder (GAD), compared to a wait-list control condition.
Read the detailed description
This was a non-inferiority trial within the context of a parallel group study with unrestricted randomisation in 1:1:1 ratio conducted in Sweden. Outcome assessors were blind to treatment status.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- iCBT, iPDT
- Keywords
- Internet treatment, GAD, guided self-help
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCBTBehavioural
Internet-delivered cognitive behavior therapy, 8 weeks
iPDTBehavioural
Internet-delivered psychodynamic therapy, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT | Experimental | Active treatment: Internet-delivered Cognitive Behavior Therapy, 8 weeks treatment, guided self-help Receives: Behavioral: iCBT |
| Internet-delivered PDT | Experimental | Active treatment: Internet-delivered Psychodynamic Therapy Active treatment: Internet-delivered Psychodynamic Therapy, 8 weeks treatment, guided self-help Receives: Behavioral: iPDT |
| Control condition | No intervention | Wait-list condition, received treatment 3 months after initial treatment period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penn State Worry Questionnaire (PSWQ)
Change from baseline in anxiety symptoms to two weeks post treatment.
Measured: Two weeks pre treatment to two weeks post treatment.
Secondary outcomes (7)
Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
Change from baseline in depressive symptoms to two weeks post treatment.
Measured: Two weeks pre treatment to two weeks post treatment
Quality of Life Inventory (QOLI)
Change from baseline in quality of life status to two weeks post treatment.
Measured: Two weeks pre treatment to two weeks post treatment
Beck Depression Inventory (BDI)
Change from baseline in depressive symptoms to two weeks post treatment.
Measured: Two weeks pre treatment to two weeks post treatment
Beck Anxiety Inventory (BAI)
Change from baseline in anxiety symptoms to two weeks post treatment.
Measured: Two weeks pre treatment to two weeks post treatment
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)
Change from baseline in societal cost of illness to two weeks post treatment.
Measured: Two weeks pre treatment to two weeks post treatment
State Trait Anxiety Inventory (STAI)
Change from baseline in anxiety symptoms to two weeks post treatment.
Measured: Two weeks pre treatment to two weeks post treatment
Generalized Anxiety Disorder Questionnaire IV (GAD-Q IV)
Change from baseline in anxiety symptoms to two weeks post treatment.
Measured: Two weeks pre treatment to two weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startJan 2009
- Primary completionOct 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies 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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Stockholm University
- Investigators
- Gerhard Andersson, Professor, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312116
- Sponsor's protocol ID
- Dnr 2007-0756
- Status last verified
- Mar 2011
- First submitted
- 7 Mar 2011
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychodynamic Versus Cognitive Behavioral Internet-Delivered Guided Self-help for Generalized Anxiety Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01312116
- Acronym / sponsor ID
- Dnr 2007-0756
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Internet treatment, GAD, guided self-help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Stockholm University
- Study start
- Jan 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Mar 2011 (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 objective is to test if Internet-delivered cognitive behavior therapy (iCBT) or Internet-delivered psychodynamic therapy (iPDT) performs better for a population with generalized anxiety disorder (GAD), compared to a wait-list control condition.
Detailed description
This was a non-inferiority trial within the context of a parallel group study with unrestricted randomisation in 1:1:1 ratio conducted in Sweden. Outcome assessors were blind to treatment status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered CBT | Experimental | Behavioral: iCBTActive treatment: Internet-delivered Cognitive Behavior Therapy, 8 weeks treatment, guided self-help |
| Internet-delivered PDT | Experimental | Behavioral: iPDTActive treatment: Internet-delivered Psychodynamic Therapy Active treatment: Internet-delivered Psychodynamic Therapy, 8 weeks treatment, guided self-help |
| Control condition | No intervention | –Wait-list condition, received treatment 3 months after initial treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- fulfill the diagnostic criteria for GAD according to DSM-IV
- have access to the Internet
- have good knowledge of the Swedish language
Key exclusion criteria (4 listed)
- recent (during last 6 weeks) change in psychiatric medication
- presently in any other psychological treatment
- severe depression
- suicidal ideation
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 |
|---|---|---|
| iCBTInternet-delivered cognitive behavior therapy, 8 weeks | Behavioural | Internet-delivered CBT |
| iPDTInternet-delivered psychodynamic therapy, 8 weeks | Behavioural | Internet-delivered PDT |
Primary outcome
Penn State Worry Questionnaire (PSWQ)
Time frame: Two weeks pre treatment to two weeks post treatment.
Change from baseline in anxiety symptoms to two weeks post treatment.
7 secondary outcomes
Montgomery Åsberg Depression Rating Scale-Self Rated (MADRS-S)
Time frame: Two weeks pre treatment to two weeks post treatment
Quality of Life Inventory (QOLI)
Time frame: Two weeks pre treatment to two weeks post treatment
Beck Depression Inventory (BDI)
Time frame: Two weeks pre treatment to two weeks post treatment
Beck Anxiety Inventory (BAI)
Time frame: Two weeks pre treatment to two weeks post treatment
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TIC-P)
Time frame: Two weeks pre treatment to two weeks post treatment
State Trait Anxiety Inventory (STAI)
Time frame: Two weeks pre treatment to two weeks post treatment
Generalized Anxiety Disorder Questionnaire IV (GAD-Q IV)
Time frame: Two weeks pre treatment to two weeks 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 10 Mar 2011.
- Project siteLink provided by the sponsor.
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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, Professor study director
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 iCBT and iPDT in people with Generalized Anxiety Disorder, 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 3 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 10 Mar 2011. 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?
Penn State Worry Questionnaire (PSWQ) (time frame: Two weeks pre treatment to two weeks post treatment.). 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 10 Mar 2011.