Social PhobiaPhase 3TSPPANCT00619138
Treatment of Social Phobia and Panic Disorder in Adults
A Phase 3 study testing individual cognitive-behavioural therapy and stepped care model in people with Social Phobia and Panic Disorder, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to compare a stepped care model for the treatment of social phobia and panic disorder with standard psychological treatment. The stepped care model comprises three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Phobia, Panic Disorder
- What is being tested?
- individual cognitive-behavioural therapy and stepped care model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2008to Dec 2015
- Phase
- Phase 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnoses of panic disorder or social phobia
- Informed consent
Who cannot join
- Alcohol/drug dependency
- Major depressive disorder
- Psychosis
- Unstable medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study of a Stepped-care Model for the Treatment of Social Phobia and Panic Disorder in Adults
The purpose of this study is to compare a stepped care model for the treatment of social phobia and panic disorder with standard psychological treatment. The stepped care model comprises three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy. Patients are assessed at each step and taken out of the study if they show significant clinical improvement and follow for 12 months. Patients are randomized to either the stepped care model or standard psychological treatment, i.e. individual cognitive-behavioural therapy. All treatment components are manualized.
- Conditions
- Social Phobia, Panic Disorder
- Being tested
- individual cognitive-behavioural therapy, stepped care model
- Keywords
- Cognitive therapy, Stepped care, Self-help, Internet, Anxiety
- Medical subject headings
- Phobia, Social, Panic Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individual cognitive-behavioural therapyBehavioural
1 session per week for 12 weeks
stepped care modelBehavioural
three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Behavioral: individual cognitive-behavioural therapy |
| 2 | Active comparator | Not described Receives: Behavioral: stepped care model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Severity Ratings
Measured: End of treatment and 12 months follow-up
Secondary outcomes (1)
Questionnaires: The Panic Attack Scale The Body Sensations Questionnaire The Agoraphobic Cognitions Questionnaire The Mobility Inventory for Agoraphobia Social Phobia Scale The Social Interaction Anxiety Scale
Measured: End of treatment and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionMay 2012
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Odd E Havik, Haukeland University Hospital
- Investigators
- odd e havik, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619138
- Sponsor's protocol ID
- 17650
- Acronym
- TSPPA
- Status last verified
- Jan 2016
- First submitted
- 16 Jan 2008
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Haug T, Nordgreen T, Ost LG, Tangen T, Kvale G, Hovland OJ, Heiervang ER, Havik OE. Working alliance and competence as predictors of outcome in cognitive behavioral therapy for social anxiety and panic disorder in adults. Behav Res Ther. 2016 Feb;77:40-51. doi: 10.1016/j.brat.2015.12.004. Epub 2015 Dec 11.
PubMed 26708332Haug T, Nordgreen T, Ost LG, Kvale G, Tangen T, Andersson G, Carlbring P, Heiervang ER, Havik OE. Stepped care versus face-to-face cognitive behavior therapy for panic disorder and social anxiety disorder: Predictors and moderators of outcome. Behav Res Ther. 2015 Aug;71:76-89. doi: 10.1016/j.brat.2015.06.002. Epub 2015 Jun 9.
PubMed 26081010
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study of a Stepped-care Model for the Treatment of Social Phobia and Panic Disorder in Adults
- ClinicalTrials.gov ID
- NCT00619138
- Acronym / sponsor ID
- TSPPA / 17650
- Conditions
- Social Phobia, Panic Disorder
- Keywords
- Cognitive therapy, Stepped care, Self-help, Internet, Anxiety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Feb 2008 (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.
The purpose of this study is to compare a stepped care model for the treatment of social phobia and panic disorder with standard psychological treatment. The stepped care model comprises three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy. Patients are assessed at each step and taken out of the study if they show significant clinical improvement and follow for 12 months. Patients are randomized to either the stepped care model or standard psychological treatment, i.e. individual cognitive-behavioural therapy. All treatment components are manualized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: individual cognitive-behavioural therapy |
| 2 | Active comparator | Behavioral: stepped care model |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnoses of panic disorder or social phobia
- Informed consent
Key exclusion criteria (4 listed)
- Alcohol/drug dependency
- Major depressive disorder
- Psychosis
- Unstable medication
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 |
|---|---|---|
| individual cognitive-behavioural therapy1 session per week for 12 weeks | Behavioural | 1 |
| stepped care modelthree steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy | Behavioural | 2 |
Primary outcome
Clinical Severity Ratings
Time frame: End of treatment and 12 months follow-up
1 secondary outcome
Questionnaires: The Panic Attack Scale The Body Sensations Questionnaire The Agoraphobic Cognitions Questionnaire The Mobility Inventory for Agoraphobia Social Phobia Scale The Social Interaction Anxiety Scale
Time frame: End of treatment and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Derived from this study: PubMed 26708332Haug T, Nordgreen T, Ost LG, Tangen T, Kvale G, Hovland OJ, Heiervang ER, Havik OE. Working alliance and competence as predictors of outcome in cognitive behavioral therapy for social anxiety and panic disorder in adults. Behav Res Ther. 2016 Feb;77:40-51. doi: 10.1016/j.brat.2015.12.004. Epub 2015 Dec 11.
- Derived from this study: PubMed 26081010Haug T, Nordgreen T, Ost LG, Kvale G, Tangen T, Andersson G, Carlbring P, Heiervang ER, Havik OE. Stepped care versus face-to-face cognitive behavior therapy for panic disorder and social anxiety disorder: Predictors and moderators of outcome. Behav Res Ther. 2015 Aug;71:76-89. doi: 10.1016/j.brat.2015.06.002. Epub 2015 Jun 9.
Related trials for Social Phobia
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder
Social Anxiety Disorder, Social Fear
Active, not recruiting
Internet-delivered Cognitive-Behavioral Therapy for Adolescents With Autism and Anxiety
Autism Spectrum Disorder, Autism
Active, not recruiting
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
Body Dysmorphic Disorder, Eating Disorders
RecruitingPhase 4
Caplyta Versus Placebo for Adults With Social Anxiety Disorder
Social Anxiety Disorder (SAD)
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.
odd e havik, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing individual cognitive-behavioural therapy and stepped care model in people with Social Phobia and Panic Disorder, run by Haukeland University Hospital at 1 site in Norway.
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 4 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: finished, as of the sponsor's last update on 26 Jan 2016. 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Severity Ratings (time frame: End of treatment and 12 months follow-up). 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 NCT00619138, which also lists 2 linked publications.
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 26 Jan 2016.