Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention Phase
Anxiety
Behavioral: Cell-phone supported CBT
Behavioral: CBT with digital audio player support
Behavioral: CBT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effectiveness Study of Cell Phone-supported Cognitive Behavioural Therapy for Anxiety Disorders in Frontline Settings

Resource links provided by NLM:


Further study details as provided by Linkoeping University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 400
Study Start Date: April 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Linkoeping University

Additional 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
Study First Received: September 16, 2010
Last Updated: June 14, 2011
Health Authority: Sweden: The National Board of Health and Welfare

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

ClinicalTrials.gov processed this record on November 23, 2014