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Definitions
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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT-ubiquitous | Experimental |
| |
| CBT-placebo | Placebo Comparator | Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management |
|
| CBT-TAU | Active Comparator | Cognitive behavioural Therapy provided 'As Usual' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell-phone supported CBT | Behavioral | Cognitive behavioural therapy provided with all-time (ubiquitous) support by cell phone applications |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Hospital Anxiety and Depression Scale-Anxiety (HADS-A), General Health Questionnaire-12 (GHQ-12), Beck's Anxiety Index (BAI) | Six months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | Data is collected from the therapists on whether the client has
| 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karin Halje, MSc | Contact | +46 10 103 0000 | karin.halje.lindgren@lio.se |
| Name | Affiliation | Role |
|---|---|---|
| Toomas Timpka, MD PhD | Section of Social Medicine/LiU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Unga Vuxna" Clinic | Recruiting | Linköping | Östergötland County | SE58185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21219593 | Derived | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| CBT with digital audio player support | Behavioral | Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management and relaxation. |
|
| CBT | Behavioral | CBT for anxiety disorders |
|