LINNEA: Cell Phone-supported Cognitive Behavioural Therapy

Sponsor

Linkoeping University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01205191

Collaborator

(none)

400

Enrollment

Location

Arms

Duration (Months)

28.5

Patients Per Site Per Month

Study Details

Study Description

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

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.

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 Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2011

Anticipated Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Jun 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Anxiety [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

Adherence [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;