AnxietyPhase 2/3LINNEANCT01205191
Cell Phone-supported Cognitive Behavioural Therapy
A Phase 2/3 study testing Cell-phone supported CBT, CBT with digital audio player support and CBT in people with Anxiety, run by Linkoeping University at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Anxiety
- What is being tested?
- Cell-phone supported CBT, CBT with digital audio player support and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2011to Jun 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18 to 25; and
- scoring 7 or higher on the anxiety section of the Hospital Anxiety and Depression scale (HADS) at initial evaluation.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
"Unga Vuxna" Clinic
Linköping, Östergötland County, SE58185
Karin Halje, MSc
About this study
Official title: Effectiveness Study of Cell Phone-supported Cognitive Behavioural Therapy for Anxiety Disorders in Frontline Settings
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.
Read more
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.
- Conditions
- Anxiety
- Being tested
- Cell-phone supported CBT, CBT with digital audio player support, CBT
- Keywords
- Cognitive behavioural therapy, Anxiety, Primary care, Effectiveness trial, Cell-phone supported therapy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-phone supported CBTBehavioural
Cognitive behavioural therapy provided with all-time (ubiquitous) support by cell phone applications
CBT with digital audio player supportBehavioural
Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management and relaxation.
CBTBehavioural
CBT for anxiety disorders
| Study group | Role | What they receive |
|---|---|---|
| CBT-ubiquitous | Experimental | Not described Receives: 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 Receives: Behavioral: CBT with digital audio player support |
| CBT-TAU | Active comparator | Cognitive behavioural Therapy provided 'As Usual' Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Hospital Anxiety and Depression Scale-Anxiety (HADS-A), General Health Questionnaire-12 (GHQ-12), Beck's Anxiety Index (BAI)
Measured: Six months after treatment
Secondary outcomes (1)
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startApr 2011
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Investigators
- Toomas Timpka, MD PhD, Principal investigator, Section of Social Medicine/LiU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205191
- Sponsor's protocol ID
- LFP5/08
- Acronym
- LINNEA
- Status last verified
- Sep 2010
- First submitted
- 16 Sep 2010
- Last updated
- 15 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21219593
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Study of Cell Phone-supported Cognitive Behavioural Therapy for Anxiety Disorders in Frontline Settings
- ClinicalTrials.gov ID
- NCT01205191
- Acronym / sponsor ID
- LINNEA / LFP5/08
- Conditions
- Anxiety
- Keywords
- Cognitive behavioural therapy, Anxiety, Primary care, Effectiveness trial, Cell-phone supported therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-ubiquitous | Experimental | Behavioral: Cell-phone supported CBT |
| CBT-placebo | Placebo comparator | Behavioral: CBT with digital audio player supportCognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management |
| CBT-TAU | Active comparator | Behavioral: CBTCognitive behavioural Therapy provided 'As Usual' |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age 18 to 25; and
- scoring 7 or higher on the anxiety section of the Hospital Anxiety and Depression scale (HADS) at initial evaluation.
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell-phone supported CBTCognitive behavioural therapy provided with all-time (ubiquitous) support by cell phone applications | Behavioural | CBT-ubiquitous |
| CBT with digital audio player supportCognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management and relaxation. | Behavioural | CBT-placebo |
| CBTCBT for anxiety disorders | Behavioural | CBT-TAU |
Primary outcome
Anxiety
Time frame: Six months after treatment
Hospital Anxiety and Depression Scale-Anxiety (HADS-A), General Health Questionnaire-12 (GHQ-12), Beck's Anxiety Index (BAI)
1 secondary outcome
Adherence
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2011.
- Derived from this study: PubMed 21219593Ekberg 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.
Related trials for Anxiety
Recruiting
A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
Pain (Knee), Pain and Anxiety
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Active, not recruiting
Preventing Anxiety and Depression in Older Hispanics
Depression, Anxiety
RecruitingPhase 1
Effects of Intranasal Oxytocin in Patients With Arginine-vasopressin Deficiency
Vasopressin Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toomas Timpka, MD PhD principal investigator
Section of Social Medicine/LiU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cell-phone supported CBT, CBT with digital audio player support and CBT in people with Anxiety, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karin Halje, MSc (+46 10 103 0000, karin.halje.lindgren@lio.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Six months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01205191, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2011; AzTrials last refreshed its copy on 27 Oct 2026.