Generalized Anxiety DisorderNCT01570374
Internet-based Treatment of Generalized Anxiety Disorder
A study testing Internet-based cognitive behavioral therapy (iCBT) in people with Generalized Anxiety Disorder, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether internet-administered cognitive behavior therapy is a feasible treatment for generalized anxiety disorder. 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?
- Internet-based cognitive behavioral therapy (iCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2012to Feb 2016
- 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
- Satisfy DSM-IV criteria for generalized anxiety disorder
- Living in Sweden and being able to read Swedish
- Access to computer with internet connection
Who cannot join
- Currently receiving other psychological treatment
- Non-stable use of psychoactive medication
- Deemed suicidal
- Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Psychology, Umeå University
Umeå, Västerbotten County, 90181
About this study
The purpose of this study is to determine whether internet-administered cognitive behavior therapy is a feasible treatment for generalized anxiety disorder.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Internet-based cognitive behavioral therapy (iCBT)
- Keywords
- Cognitive behavioral therapy, Internet, Anxiety, Generalized anxiety disorder
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavioral therapy (iCBT)Behavioural
9 week internet-administered, therapist-assisted, controlled-progression cognitive behavioral therapy (iCBT). Individualized and disorder-specific.
| Study group | Role | What they receive |
|---|---|---|
| iCBT | Experimental | Receives treatment. Receives: Behavioral: Internet-based cognitive behavioral therapy (iCBT) |
| Waiting list control group | No intervention | The waiting list control group initially receives no treatment, but do weekly screenings. After 9 weeks, the control group receives the same treatment as the other study arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Measured: 24 hours
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Measured: 6 months
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Measured: 12 months
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Measured: 24 months
Secondary outcomes (22)
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Measured: 24 hours
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Measured: 6 months
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Measured: 12 months
Change from baseline in Beck Anxiety Inventory (BAI)
21 item rating scale for anxiety symptoms.
Measured: 24 months
Change from baseline in Quality Of Life Inventory (QOLI)
The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
Measured: 24 hours
Change from baseline in Quality Of Life Inventory (QOLI)
The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
Measured: 6 months
Change from baseline in Quality Of Life Inventory (QOLI)
The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
Measured: 12 months
Change from baseline in Quality Of Life Inventory (QOLI)
The QOLI assessment yields an overall score and a profile of problems and strengths in 16 areas of life such as love, work and play. The QOLI test is a measure of positive psychology and positive mental health.
Measured: 24 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Measured: 24 hours
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Measured: 6 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Measured: 12 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
9-item depression rating scale.
Measured: 24 months
Change from baseline in Patient Health Questionnaire (PHQ-9)
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Measured: Weekly during treatment period
Change from baseline in Patient Health Questionnaire (PHQ-9)
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Measured: 24 hours
Change from baseline in Patient Health Questionnaire (PHQ-9)
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Measured: 6 months
Change from baseline in Patient Health Questionnaire (PHQ-9)
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Measured: 12 months
Change from baseline in Patient Health Questionnaire (PHQ-9)
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. The PHQ-9 is a powerful tool for assisting primary care clinicians in diagnosing depression as well as selecting and monitoring treatment. The PHQ-9 is based directly on the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual Fourth Edition (DSM-IV).
Measured: 24 months
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Measured: Weekly during treatment period
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Measured: 24 hours
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Measured: 6 months
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Measured: 12 months
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
7-item screening form for Generalized Anxiety Disorder.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2016
- Study completionFeb 2016
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 Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Umeå 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Carlbring, PhD, Umeå University
- Investigators
- Per Carlbring, Professor, Principal investigator, Department of Psychology, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570374
- Sponsor's protocol ID
- Oroshjalpen
- Status last verified
- Oct 2016
- First submitted
- 31 Mar 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Dahlin M, Andersson G, Magnusson K, Johansson T, Sjogren J, Hakansson A, Pettersson M, Kadowaki A, Cuijpers P, Carlbring P. Internet-delivered acceptance-based behaviour therapy for generalized anxiety disorder: A randomized controlled trial. Behav Res Ther. 2016 Feb;77:86-95. doi: 10.1016/j.brat.2015.12.007. Epub 2015 Dec 21.
PubMed 26731173
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Treatment of Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT01570374
- Acronym / sponsor ID
- Oroshjalpen
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Cognitive behavioral therapy, Internet, Anxiety, Generalized anxiety disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Apr 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.
The purpose of this study is to determine whether internet-administered cognitive behavior therapy is a feasible treatment for generalized anxiety disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCBT | Experimental | Behavioral: Internet-based cognitive behavioral therapy (iCBT)Receives treatment. |
| Waiting list control group | No intervention | –The waiting list control group initially receives no treatment, but do weekly screenings. After 9 weeks, the control group receives the same treatment as the other study arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Satisfy DSM-IV criteria for generalized anxiety disorder
- Living in Sweden and being able to read Swedish
- Access to computer with internet connection
Key exclusion criteria (4 listed)
- Currently receiving other psychological treatment
- Non-stable use of psychoactive medication
- Deemed suicidal
- Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.
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-based cognitive behavioral therapy (iCBT)9 week internet-administered, therapist-assisted, controlled-progression cognitive behavioral therapy (iCBT). Individualized and disorder-specific. | Behavioural | iCBT |
Primary outcome
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Time frame: 24 hours
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Time frame: 6 months
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Time frame: 12 months
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
Change from baseline in Penn State Worry Questionnaire (PSWQ)
Time frame: 24 months
Measures anxiety symptoms related to Generalized Anxiety Disorder. 16 items.
22 secondary outcomes
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: 24 hours
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: 6 months
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: 12 months
Change from baseline in Beck Anxiety Inventory (BAI)
Time frame: 24 months
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 24 hours
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 6 months
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 12 months
Change from baseline in Quality Of Life Inventory (QOLI)
Time frame: 24 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 24 hours
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 6 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 12 months
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 24 months
Change from baseline in Patient Health Questionnaire (PHQ-9)
Time frame: Weekly during treatment period
Change from baseline in Patient Health Questionnaire (PHQ-9)
Time frame: 24 hours
Change from baseline in Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
Change from baseline in Patient Health Questionnaire (PHQ-9)
Time frame: 12 months
Change from baseline in Patient Health Questionnaire (PHQ-9)
Time frame: 24 months
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Weekly during treatment period
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 24 hours
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 6 months
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 12 months
Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 24 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 1 Nov 2016.
- Results publication: PubMed 26731173Dahlin M, Andersson G, Magnusson K, Johansson T, Sjogren J, Hakansson A, Pettersson M, Kadowaki A, Cuijpers P, Carlbring P. Internet-delivered acceptance-based behaviour therapy for generalized anxiety disorder: A randomized controlled trial. Behav Res Ther. 2016 Feb;77:86-95. doi: 10.1016/j.brat.2015.12.007. Epub 2015 Dec 21.
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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.
Per Carlbring, Professor principal investigator
Department of Psychology, Umeå 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 Internet-based cognitive behavioral therapy (iCBT) in people with Generalized Anxiety Disorder, run by Umeå 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 1 Nov 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 from baseline in Penn State Worry Questionnaire (PSWQ) (time frame: 24 hours). The study lists 4 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 NCT01570374, 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 1 Nov 2016.