Cell Phone-supported Cognitive Behavioural Therapy

Study Overview
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Brief Summary
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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 to compare the relative effectiveness of a computerized ubiquitous CBT (CBT-ubiquitous) against anxiety disorders with CBT-treatment as usual (CBT-TAU); 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.

Official Title
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Effectiveness Study of Cell Phone-supported Cognitive Behavioural Therapy for Anxiety Disorders in Frontline Settings

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Cell-phone supported CBT
* Behavioral: CBT with digital audio player support
* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 to 25; and scoring 7 or higher on the anxiety section of the Hospital Anxiety and Depression scale (HADS) at initial evaluation. Exclusion Criteria: at the initial evaluation displays symptoms indicative for referral to a psychiatric specialist, e.g. active suicidal ideas or symptoms of a psychotic disorder, organic mental disorder or alcohol and/or drug dependence; or is unable to read, write or speak in the Swedish;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-ubiquitous<br> | Behavioral: Cell-phone supported CBT<br>* Cognitive behavioural therapy provided with all-time (ubiquitous) support by cell phone applications<br>|
| Placebo Comparator: CBT-placebo<br>Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management | Behavioral: CBT with digital audio player support<br>* Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management and relaxation.<br>|
| Active Comparator: CBT-TAU<br>Cognitive behavioural Therapy provided 'As Usual' | Behavioral: CBT<br>* CBT for anxiety disorders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Data is collected from the therapists on whether the client has discontinued the CBT program by not showing up at sessions; discontinued the CBT program by actively informing the therapist; been discontinued from the treatment by the therapist; fulfilled the therapeutic contract, e.g. by completing 'homework' agreed upon. | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive behavioural therapy, Anxiety, Primary care, Effectiveness trial, Cell-phone supported therapy