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Cell Phone-supported Cognitive Behavioural Therapy (LINNEA)

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ClinicalTrials.gov Identifier: NCT01205191
Recruitment Status : Unknown
Verified September 2010 by Linkoeping University.
Recruitment status was:  Recruiting
First Posted : September 20, 2010
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:
Linkoeping University

Brief Summary:

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

  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.


Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Cell-phone supported CBT Behavioral: CBT with digital audio player support Behavioral: CBT Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness Study of Cell Phone-supported Cognitive Behavioural Therapy for Anxiety Disorders in Frontline Settings
Study Start Date : April 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Anxiety [ Time Frame: Six months after treatment ]
    Hospital Anxiety and Depression Scale-Anxiety (HADS-A), General Health Questionnaire-12 (GHQ-12), Beck's Anxiety Index (BAI)


Secondary Outcome Measures :
  1. Adherence [ Time Frame: 14 weeks ]

    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205191


Contacts
Contact: Karin Halje, MSc +46 10 103 0000 karin.halje.lindgren@lio.se

Locations
Sweden
"Unga Vuxna" Clinic Recruiting
Linkoping, Ostergotland, Sweden, SE58185
Principal Investigator: Karin Halje, MSc         
Sponsors and Collaborators
Linkoeping University
Investigators
Principal Investigator: Toomas Timpka, MD PhD Section of Social Medicine/LiU

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Toomas Timpka, professor, Section of Social Medicince/LiU
ClinicalTrials.gov Identifier: NCT01205191     History of Changes
Other Study ID Numbers: LFP5/08
First Posted: September 20, 2010    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: September 2010

Keywords provided by Linkoeping University:
Cognitive behavioural therapy
Anxiety
Primary care
Effectiveness trial
Cell-phone supported therapy

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders