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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001353
Receipt No. 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

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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 Link&#246;ping University
Division name Department of Behavioural Sciences and Learning.
Zip code
Address SE-581 83 LINK&#214;PING, Sweden
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Link&#246;ping University
Division name Department of Behavioural Sciences and Learning.
Zip code
Address
TEL
Homepage URL http://www.kbt.info/origo
Email origo@kbt.info

Sponsor
Institute Linkoping University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001646

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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