Cell Phone-supported Cognitive Behavioural Therapy (LINNEA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Linkoeping University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Linkoeping University
ClinicalTrials.gov Identifier:
NCT01205191
First received: September 16, 2010
Last updated: June 14, 2011
Last verified: September 2010

September 16, 2010
June 14, 2011
April 2011
June 2012   (final data collection date for primary outcome measure)
Anxiety [ Time Frame: Six months after treatment ] [ Designated as safety issue: No ]
Hospital Anxiety and Depression Scale-Anxiety (HADS-A), General Health Questionnaire-12 (GHQ-12), Beck's Anxiety Index (BAI)
Same as current
Complete list of historical versions of study NCT01205191 on ClinicalTrials.gov Archive Site
Adherence [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

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.
Same as current
Not Provided
Not Provided
 
Cell Phone-supported Cognitive Behavioural Therapy
Effectiveness Study of Cell Phone-supported Cognitive Behavioural Therapy for Anxiety Disorders in Frontline Settings

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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Anxiety
  • Behavioral: Cell-phone supported CBT
    Cognitive behavioural therapy provided with all-time (ubiquitous) support by cell phone applications
  • 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.
  • Behavioral: CBT
    CBT for anxiety disorders
  • Experimental: CBT-ubiquitous
    Intervention: Behavioral: Cell-phone supported CBT
  • Placebo Comparator: CBT-placebo
    Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management
    Intervention: Behavioral: CBT with digital audio player support
  • Active Comparator: CBT-TAU
    Cognitive behavioural Therapy provided 'As Usual'
    Intervention: Behavioral: CBT
Ekberg J, Timpka T, Bång M, Fröberg 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2012
June 2012   (final data collection date for primary outcome measure)

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;
Both
18 Years to 25 Years
No
Contact: Karin Halje, MSc +46 10 103 0000 karin.halje.lindgren@lio.se
Sweden
 
NCT01205191
LFP5/08
Yes
Toomas Timpka, professor, Section of Social Medicince/LiU
Linkoeping University
Not Provided
Principal Investigator: Toomas Timpka, MD PhD Section of Social Medicine/LiU
Linkoeping University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP