Cell Phone-supported Cognitive Behavioural Therapy

Anxiety Clinical Trial

— LINNEA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01205191
• Other study ID #: LFP5/08
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 16, 2010
• Last updated: June 14, 2011
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2010
• Source: Linkoeping University
• Contact: Karin Halje, MSc
• Phone: +46 10 103 0000
• Email: karin.halje.lindgren[@]lio.se
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anxiety

Intervention

Behavioral:
• Cell-phone supported CBT
Cognitive behavioural therapy provided with all-time (ubiquitous) support by cell phone applications
• 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.
• CBT
CBT for anxiety disorders

Locations

Country	Name	City	State
Sweden	"Unga Vuxna" Clinic	Linkoping	Ostergotland

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	Hospital Anxiety and Depression Scale-Anxiety (HADS-A), General Health Questionnaire-12 (GHQ-12), Beck's Anxiety Index (BAI)	Six months after treatment	No
Secondary	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	No