Panic DisorderPhase 3IP2NCT00845260
Internet-Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder
A Phase 3 study testing Internet-based cognitive behavior therapy (CBT). and Group CBT in people with Panic Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated, often chronic psychiatric disorder. The are effective pharmacological as well as psychological treatments for PD/A. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Internet-based cognitive behavior therapy (CBT). and Group CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2004to Dec 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Panic Disorder with or without Agoraphobia (PD/A)
Who cannot join
- active substance abuse
- physiological etiology of panic symptoms
- under 18 years of age
- severe depression or suicidal ideation.
- if on drugs for PD, not having had a constant dosage for 2 months
- undergoing other cognitive behavioral treatment
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of Clinical Neuroscience, Section of psychiatry, Karolinska Hospital Solna R5
Stockholm, 171 76
About this study
Official title: Internet- Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder in a Psychiatric Setting: A Randomized Equivalence Trial
Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated, often chronic psychiatric disorder. The are effective pharmacological as well as psychological treatments for PD/A. Because of the lack of availability of the most effective psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments have been developed. One of those are Internet-based CBT. The aim of this study is to compare the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113 patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks). The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is that treatments will show equal effectiveness.
- Conditions
- Panic Disorder
- Being tested
- Internet-based cognitive behavior therapy (CBT)., Group CBT
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavior therapy (CBT).Behavioural
Self-help program and guidance by psychologist via e-mail during 10 weeks.
Group CBTBehavioural
Group cognitive behavior therapy (CBT) during 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT | Experimental | Internet-based cognitive behavior therapy (CBT). Receives: Behavioral: Internet-based cognitive behavior therapy (CBT). |
| Group CBT | Experimental | Group cognitive behavior therapy (CBT). Receives: Behavioral: Group CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Panic Disorder Severity Scale (PDSS)
Measured: Pre, post at 6-month follow-up
Secondary outcomes (1)
Montgomery-Åsberg Depression Rating Scale (MADRS) Anxiety Sensitivity Index (ASI) Sheehan Disability Scale (SDS)
Measured: Pre, post and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startDec 2004
- Primary completionDec 2007
- Study completionDec 2007
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 Panic DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Investigators
- Nils Lindefors, MD, PhD, professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845260
- Sponsor's protocol ID
- IP2
- Other IDs
- Dnr 04-034/4
- Acronym
- IP2
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lonsdorf TB, Ruck C, Bergstrom J, Andersson G, Ohman A, Lindefors N, Schalling M. The COMTval158met polymorphism is associated with symptom relief during exposure-based cognitive-behavioral treatment in panic disorder. BMC Psychiatry. 2010 Nov 26;10:99. doi: 10.1186/1471-244X-10-99.
PubMed 21110842Bergstrom J, Andersson G, Ljotsson B, Ruck C, Andreewitch S, Karlsson A, Carlbring P, Andersson E, Lindefors N. Internet-versus group-administered cognitive behaviour therapy for panic disorder in a psychiatric setting: a randomised trial. BMC Psychiatry. 2010 Jul 2;10:54. doi: 10.1186/1471-244X-10-54.
PubMed 20598127
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet- Versus Group-Administered Cognitive Behavior Therapy for Panic Disorder in a Psychiatric Setting: A Randomized Equivalence Trial
- ClinicalTrials.gov ID
- NCT00845260
- Acronym / sponsor ID
- IP2 / IP2
- Conditions
- Panic Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Dec 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 18 Feb 2009 (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.
Panic Disorder with or without agoraphobia (PD/A) is a common, and unless it is treated, often chronic psychiatric disorder. The are effective pharmacological as well as psychological treatments for PD/A. Because of the lack of availability of the most effective psychological treatment, cognitive behavior therapy (CBT), self-help based CBT treatments have been developed. One of those are Internet-based CBT. The aim of this study is to compare the effectiveness of Internet and group CBT for PD/A in a regular psychiatric setting. 113 patients are consecutively and randomly assigned to either treatment (both lasting 10 weeks). The main outcome measure is the Panic Disorder Severity Scale(PDSS). The study hypothesis is that treatments will show equal effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet CBT | Experimental | Behavioral: Internet-based cognitive behavior therapy (CBT).Internet-based cognitive behavior therapy (CBT). |
| Group CBT | Experimental | Behavioral: Group CBTGroup cognitive behavior therapy (CBT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary Panic Disorder with or without Agoraphobia (PD/A)
Key exclusion criteria (6 listed)
- active substance abuse
- physiological etiology of panic symptoms
- under 18 years of age
- severe depression or suicidal ideation.
- if on drugs for PD, not having had a constant dosage for 2 months
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 |
|---|---|---|
| Internet-based cognitive behavior therapy (CBT).Self-help program and guidance by psychologist via e-mail during 10 weeks. | Behavioural | Internet CBT |
| Group CBTGroup cognitive behavior therapy (CBT) during 10 weeks. | Behavioural | Group CBT |
Primary outcome
Panic Disorder Severity Scale (PDSS)
Time frame: Pre, post at 6-month follow-up
1 secondary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS) Anxiety Sensitivity Index (ASI) Sheehan Disability Scale (SDS)
Time frame: Pre, post and 6-month 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 18 Feb 2009.
- Derived from this study: PubMed 21110842Lonsdorf TB, Ruck C, Bergstrom J, Andersson G, Ohman A, Lindefors N, Schalling M. The COMTval158met polymorphism is associated with symptom relief during exposure-based cognitive-behavioral treatment in panic disorder. BMC Psychiatry. 2010 Nov 26;10:99. doi: 10.1186/1471-244X-10-99.
- Derived from this study: PubMed 20598127Bergstrom J, Andersson G, Ljotsson B, Ruck C, Andreewitch S, Karlsson A, Carlbring P, Andersson E, Lindefors N. Internet-versus group-administered cognitive behaviour therapy for panic disorder in a psychiatric setting: a randomised trial. BMC Psychiatry. 2010 Jul 2;10:54. doi: 10.1186/1471-244X-10-54.
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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.
Nils Lindefors, MD, PhD, professor principal investigator
Karolinska Institutet
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 Internet-based cognitive behavior therapy (CBT). and Group CBT in people with Panic Disorder, run by Karolinska Institutet 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 1 inclusion and 6 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 18 Feb 2009. 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. 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?
Panic Disorder Severity Scale (PDSS) (time frame: Pre, post at 6-month 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 NCT00845260, 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 18 Feb 2009.