UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001353 |
|---|---|
| Receipt number | R000001646 |
| Scientific Title | Origo - A randomized clinical trial of internet-delivered cognitive behaviour therapy for generalized anxiety disorder |
| Date of disclosure of the study information | 2008/11/01 |
| Last modified on | 2008/09/03 14:47:26 |
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Basic information
Public title
Origo - A randomized clinical trial of internet-delivered cognitive behaviour therapy for generalized anxiety disorder
Acronym
An RCT of internetdelivered cbt for GAD
Scientific Title
Origo - A randomized clinical trial of internet-delivered cognitive behaviour therapy for generalized anxiety disorder
Scientific Title:Acronym
An RCT of internetdelivered cbt for GAD
Region
| Europe |
Condition
Condition
Generalized anxiety disorder (GAD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if a population suffering from generalized anxiety disorder could benefit from an Internet-delivered CBT with therapist guidance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DSM-IV GAD-diagnosis as measured with the SCID-I
Key secondary outcomes
Penn State Worry Questionnaire, the Generalized Anxiety Disorder Questionnaire IV, the Montgomery Åsberg Depression Rating Scale - Self rated,State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Beck Depression Inventory (BDI), The Alcohol Use Disorders Identification Test (AUDIT), Euroqol (EQ-5D)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Internet-delivered CBT with therapist guidance
Interventions/Control_2
Treatment as usual
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
DSM-IV GAD-diagnosis
Key exclusion criteria
High suicidal risc, severely depressed, ongoing psychological treatment, severe alcohol dependence
Target sample size
89
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Gerhard Andersson |
Organization
Linköping University
Division name
Department of Behavioural Sciences and Learning.
Zip code
Address
SE-581 83 LINKÖPING, Sweden
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Linköping University
Division name
Department of Behavioural Sciences and Learning.
Zip code
Address
TEL
Homepage URL
http://www.kbt.info/origo
origo@kbt.info
Sponsor or person
Institute
Linkoping University
Institute
Department
Personal name
Funding Source
Organization
Swedish council for working life and social research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Sweden
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2006 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 03 | Day |
Last modified on
| 2008 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001646
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
