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Cell Phone-supported Cognitive Behavioural Therapy

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01205191
Acronym
LINNEA
Enrollment
400
Registered
2010-09-20
Start date
2011-04-30
Completion date
2012-06-30
Last updated
2011-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Cognitive behavioural therapy, Anxiety, Primary care, Effectiveness trial, Cell-phone supported therapy

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 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.

Interventions

BEHAVIORALCell-phone supported CBT

Cognitive behavioural therapy provided with all-time (ubiquitous) support by cell phone applications

BEHAVIORALCBT 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.

BEHAVIORALCBT

CBT for anxiety disorders

Sponsors

Linkoeping University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
AnxietySix months after treatmentHospital Anxiety and Depression Scale-Anxiety (HADS-A), General Health Questionnaire-12 (GHQ-12), Beck's Anxiety Index (BAI)

Secondary

MeasureTime frameDescription
Adherence14 weeksData 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.

Countries

Sweden

Contacts

Primary ContactKarin Halje, MSc
karin.halje.lindgren@lio.se+46 10 103 0000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026