Cell Phone-supported Cognitive Behavioural Therapy (LINNEA)

Linköping University (LiU)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Anxiety

Treatments: Behavioral: Cell-phone supported CBT; Behavioral: CBT with digital audio player support; Behavioral: CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT01205191

LFP5/08

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No 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;

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups, including a placebo group

CBT-ubiquitous

Experimental group

Treatment:

Behavioral: Cell-phone supported CBT

CBT-placebo

Placebo Comparator group

Description:

Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management

Treatment:

Behavioral: CBT with digital audio player support

CBT-TAU

Active Comparator group

Description:

Cognitive behavioural Therapy provided 'As Usual'

Treatment:

Behavioral: CBT