Panic DisorderPhase 1NCT00063375
Interactive Computer Treatment for Panic Disorder
A Phase 1 study testing Computer Based Cognitive Behavioral Therapy in people with Panic Disorder, run by Florida State University at 1 site in United States.
Trial summary
This study will develop an interactive computer-based version of cognitive behavioral therapy (CBT) and compare its effectiveness to book-based CBT for the treatment of panic disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Computer Based Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Feb 2007
- Phase
- Phase 1
- 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
- DSM-IV diagnosis of panic disorder, with or without agoraphobia
Who cannot join
- Change in medication type or dose 12 weeks prior to study entry
- Suicidal
- Current substance abuse
- Current or past schizophrenia, bipolar disorder, or organic mental disorder. Patients on medications must meet stability requirements such that initial administration of the medication and dose has been maintained for at least 3 months prior to treatment and will be maintained until post-treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
This study will develop an interactive computer-based version of cognitive behavioral therapy (CBT) and compare its effectiveness to book-based CBT for the treatment of panic disorder.
Read the detailed description
Panic disorder (PD) is a highly prevalent and debilitating condition. Unfortunately, many people with PD go untreated because of the high cost and low availability of treatment. Research shows that CBT is an effective treatment for PD. When administered as a self-help, computer based treatment, CBT may provide a less expensive, more engaging treatment for PD.
Participants in this study will be randomly assigned to receive computer based treatment, book based treatment, or no treatment for 10 weeks. After these 10 weeks, symptoms of anxiety and depression will be measured with patient interviews, scales, and questionnaires.
- Conditions
- Panic Disorder
- Being tested
- Computer Based Cognitive Behavioral Therapy
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Based Cognitive Behavioral TherapyBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2003 (estimated)
- Study startJan 2002
- Primary completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063375
- Sponsor's protocol ID
- R21MH062056
- Other IDs
- R21MH062056, DSIR AT-AS
- Status last verified
- Oct 2021
- First submitted
- 25 Jun 2003
- Last updated
- 4 Nov 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Computer Treatment for Panic Disorder
- ClinicalTrials.gov ID
- NCT00063375
- Acronym / sponsor ID
- R21MH062056
- Conditions
- Panic Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2002
- Primary completion
- Feb 2007 (actual)
- First posted
- 27 Jun 2003 (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.
This study will develop an interactive computer-based version of cognitive behavioral therapy (CBT) and compare its effectiveness to book-based CBT for the treatment of panic disorder.
Detailed description
Panic disorder (PD) is a highly prevalent and debilitating condition. Unfortunately, many people with PD go untreated because of the high cost and low availability of treatment. Research shows that CBT is an effective treatment for PD. When administered as a self-help, computer based treatment, CBT may provide a less expensive, more engaging treatment for PD.
Participants in this study will be randomly assigned to receive computer based treatment, book based treatment, or no treatment for 10 weeks. After these 10 weeks, symptoms of anxiety and depression will be measured with patient interviews, scales, and questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DSM-IV diagnosis of panic disorder, with or without agoraphobia
Key exclusion criteria (4 listed)
- Change in medication type or dose 12 weeks prior to study entry
- Suicidal
- Current substance abuse
- Current or past schizophrenia, bipolar disorder, or organic mental disorder. Patients on medications must meet stability requirements such that initial administration of the medication and dose has been maintained for at least 3 months prior to treatment and will be maintained until post-treatment.
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 |
|---|---|---|
| Computer Based Cognitive Behavioral Therapy | Behavioural | – |
Primary outcome
Not reported in the source record.
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 4 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Computer Based Cognitive Behavioral Therapy in people with Panic Disorder, run by Florida State University at 1 site in United States.
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 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 4 Nov 2021. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
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 4 Nov 2021.