Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
400 participants
INTERVENTIONAL
2011-04-30
2012-06-30
Brief Summary
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CBT-ubiquitous - Cognitive behavioural therapy (CBT) provided with all-time (ubiquitous) support by cell phone applications CBT-TAU - Cognitive behavioural Therapy provided 'As Usual' CBT-placebo - Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management and relaxation.
Study objectives
1. to compare the relative effectiveness of a computerized ubiquitous CBT (CBT-ubiquitous) against anxiety disorders with CBT-treatment as usual (CBT-TAU);
2. to assess the safety and tolerability of the CBT-ubiquitous as compared with CBT-TAU and CBT provided with access to a placebo technical device (CBT-placebo)..
Study implementation
The investigators hypothesize that all active treatments are superior to placebo given evidence that face-to-face CBT is effective in the treatment of both anxiety and depression. The investigators also predict that patients receiving CBT-ubiquitous will show greater improvement than those given CBT-TAU, and assume that CBT-ubiquitous leads to improved adherence with treatment compared to CBT-TAU and CBT-placebo.
The investigators will use an intention to treat (ITT) approach to fulfill the study aims, by which the investigators mean that clients are analysed as randomized rather than by treatment actually received. The study will be implemented in the central district of Östergötland County Council (pop 145.000). The research group has in two previous projects (VINNOVA 2005-2007, VINNOVA 2008-2009) established cooperation with the 'Unga Vuxna' (Young Adults) service provided in this district. The service supplies CBT to the subpopulation experiencing early stages of mental disorders in the age group 16-25 years (n=20,000) in order to prevent development of significant psychiatric disease and disability. The service employs six therapists with at least one year specific CBT training and is co-located with Primary Healthcare Centres (PHCs) in downtown Linköping, Åtvidaberg and Kisa. Clients staying outside the urban areas can make appointments with therapists at their closest PHC on a weekly basis.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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CBT-ubiquitous
Cell-phone supported CBT
Cognitive behavioural therapy provided with all-time (ubiquitous) support by cell phone applications
CBT-placebo
Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management
CBT with digital audio player support
Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management and relaxation.
CBT-TAU
Cognitive behavioural Therapy provided 'As Usual'
CBT
CBT for anxiety disorders
Interventions
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Cell-phone supported CBT
Cognitive behavioural therapy provided with all-time (ubiquitous) support by cell phone applications
CBT with digital audio player support
Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management and relaxation.
CBT
CBT for anxiety disorders
Eligibility Criteria
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Inclusion Criteria
* scoring 7 or higher on the anxiety section of the Hospital Anxiety and Depression scale (HADS) at initial evaluation.
Exclusion Criteria
* is unable to read, write or speak in the Swedish;
18 Years
25 Years
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Section of Social Medicince/LiU
Principal Investigators
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Toomas Timpka, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Section of Social Medicine/LiU
Locations
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"Unga Vuxna" Clinic
Linköping, Östergötland County, Sweden
Countries
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Central Contacts
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References
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Ekberg J, Timpka T, Bang M, Froberg A, Halje K, Eriksson H. Cell phone-supported cognitive behavioural therapy for anxiety disorders: a protocol for effectiveness studies in frontline settings. BMC Med Res Methodol. 2011 Jan 10;11:3. doi: 10.1186/1471-2288-11-3.
Other Identifiers
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LFP5/08
Identifier Type: -
Identifier Source: org_study_id
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