Cell Phone-supported Cognitive Behavioural Therapy

NCT01205191 | Unknown Phase 2 DMC

• 1 other identifier: LFP5/08
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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. 1.to compare the relative effectiveness of a computerized ubiquitous CBT (CBT-ubiquitous) against anxiety disorders with CBT-treatment as usual (CBT-TAU);
2. 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)..

Conditions

Anxiety

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Anxiety

  Hospital Anxiety and Depression Scale-Anxiety (HADS-A), General Health Questionnaire-12 (GHQ-12), Beck's Anxiety Index (BAI)

  Six months after treatment

Secondary Outcomes (1)

• Adherence

  14 weeks

Study Arms (3)

CBT-ubiquitous

EXPERIMENTAL

Behavioral: Cell-phone supported CBT

CBT-placebo

PLACEBO COMPARATOR

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

CBT-TAU

ACTIVE COMPARATOR

Cognitive behavioural Therapy provided 'As Usual'

Behavioral: CBT

Interventions

Cell-phone supported CBT BEHAVIORAL

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

CBT-ubiquitous

CBT with digital audio player support BEHAVIORAL

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

CBT-placebo

CBT BEHAVIORAL

CBT for anxiety disorders

CBT-TAU

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age 18 to 25; and
• scoring 7 or higher on the anxiety section of the Hospital Anxiety and Depression scale (HADS) at initial evaluation.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

"Unga Vuxna" Clinic

Linköping, Östergötland County, SE58185, Sweden

RECRUITING

Related Publications (1)

• Ekberg J, Timpka T, Bang M, Froberg A, Halje K, Eriksson H. Cell phone-supported cognitive behavioural therapy for anxiety disorders: a protocol for effectiveness studies in frontline settings. BMC Med Res Methodol. 2011 Jan 10;11:3. doi: 10.1186/1471-2288-11-3.

  PMID: 21219593 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Toomas Timpka, MD PhD

  Section of Social Medicine/LiU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Halje, MSc

CONTACT

+46 10 103 0000; karin.halje.lindgren@lio.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 20, 2010
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 15, 2011

Record last verified: 2010-09

Locations

SE (1)