Panic DisorderCBTNCT00772746
Cognitive Behavioral Therapy in Panic Disorder
An observational study of Panic Disorder, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
The investigators hypothesized that the group of patients receiving the medication interventions and CBT would show significant changes in their behavior, such as remission or reduction in anxiety, panic attacks, anticipatory anxiety, fear of body sensations, loss of control, and agoraphobia avoidance. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Panic Disorder
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2006to Mar 2007
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: panic disoder patients over 18 years old
Who may be able to join
- Patients over 18 years old
- Both genders with a diagnosis of panic disorder and agoraphobia without severe comorbidities.
Who cannot join
- Patients showing alcohol or drug dependence
- Mental retardation
- Any other severe mental disorder.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 22291-140
About this study
Official title: Effectiveness of Specific Model of Cognitive-Behavioral Therapy in Panic Disorder Patients With Agoraphobia
The investigators hypothesized that the group of patients receiving the medication interventions and CBT would show significant changes in their behavior, such as remission or reduction in anxiety, panic attacks, anticipatory anxiety, fear of body sensations, loss of control, and agoraphobia avoidance. And also, in the general evaluation of well-being, in the beginning and end of the treatment, in comparison to the control group (medication without CBT), during the same period.
Read the detailed description
This trial consisted in tracing the profile and evaluating their response to cognitive-behavioral techniques in a sample of 50 panic disorder patients with agoraphobia treated at the Psychiatric Institute of the Federal University of Rio de Janeiro/Brazil. Objective: To test a specific model of cognitive-behavioral therapy through instruments applied in the beginning and end of the procedures. Two groups of 25 patients were formed, the first one with medication and therapy and the second one with medication and without therapy, as the control group. Methods: The cognitive-behavioral therapy sessions were held weekly and individually, with one-hour sessions. The work focused on physiological, cognitive and behavioral aspects with techniques of cognitive reorganization, exercises of induction of symptoms, "in vivo" exposure, breathing and relaxation exercises. The prescribed medication consists of tricyclic antidepressants (TCA) or selective serotonin reuptake inhibitors (SSRI). Results: There was a significant difference between the initial and final evaluation of the group with the specific therapy, such as, reduction in panic attacks, anticipatory anxiety, agoraphobia avoidance, and fear of body sensations. In the global assessment functioning scale, global well-being increased from 60.8% to 72.5% among patients in the first group with therapy, differently from the group without therapy. We observed that 77.6% of the sample in both groups presented the respiratory subtype and 22.4% the non-respiratory subtype. Conclusion: The association of specific cognitive-behavioral therapy focusing on somatic complaints associated with pharmacologic treatment in the first group was effective in this sample, in comparison to pharmacological treatment alone in panic disorder patients with agoraphobia.
- Conditions
- Panic Disorder
- Keywords
- panic, respiration, anxiety, exercise, cognition
- Medical subject headings
- Panic Disorder, Respiratory Aspiration, Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| exercise | Respiratory and cognitive exercises in panic disorder patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory
Measured: for observational studies
Secondary outcomes (1)
Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory
Measured: for observational studies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startMar 2006
- Primary completionMar 2007
- Study completionMar 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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Investigators
- Antonio E Nardi, MD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772746
- Sponsor's protocol ID
- ALSK 021
- Other IDs
- ALK-123456-1
- Acronym
- CBT
- Status last verified
- Oct 2008
- First submitted
- 14 Oct 2008
- Last updated
- 15 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Specific Model of Cognitive-Behavioral Therapy in Panic Disorder Patients With Agoraphobia
- ClinicalTrials.gov ID
- NCT00772746
- Acronym / sponsor ID
- CBT / ALSK 021
- Conditions
- Panic Disorder
- Keywords
- panic, respiration, anxiety, exercise, cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 15 Oct 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 investigators hypothesized that the group of patients receiving the medication interventions and CBT would show significant changes in their behavior, such as remission or reduction in anxiety, panic attacks, anticipatory anxiety, fear of body sensations, loss of control, and agoraphobia avoidance. And also, in the general evaluation of well-being, in the beginning and end of the treatment, in comparison to the control group (medication without CBT), during the same period.
Detailed description
This trial consisted in tracing the profile and evaluating their response to cognitive-behavioral techniques in a sample of 50 panic disorder patients with agoraphobia treated at the Psychiatric Institute of the Federal University of Rio de Janeiro/Brazil. Objective: To test a specific model of cognitive-behavioral therapy through instruments applied in the beginning and end of the procedures. Two groups of 25 patients were formed, the first one with medication and therapy and the second one with medication and without therapy, as the control group. Methods: The cognitive-behavioral therapy sessions were held weekly and individually, with one-hour sessions. The work focused on physiological, cognitive and behavioral aspects with techniques of cognitive reorganization, exercises of induction of symptoms, "in vivo" exposure, breathing and relaxation exercises. The prescribed medication consists of tricyclic antidepressants (TCA) or selective serotonin reuptake inhibitors (SSRI). Results: There was a significant difference between the initial and final evaluation of the group with the specific therapy, such as, reduction in panic attacks, anticipatory anxiety, agoraphobia avoidance, and fear of body sensations. In the global assessment functioning scale, global well-being increased from 60.8% to 72.5% among patients in the first group with therapy, differently from the group without therapy. We observed that 77.6% of the sample in both groups presented the respiratory subtype and 22.4% the non-respiratory subtype. Conclusion: The association of specific cognitive-behavioral therapy focusing on somatic complaints associated with pharmacologic treatment in the first group was effective in this sample, in comparison to pharmacological treatment alone in panic disorder patients with agoraphobia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise | – | –Respiratory and cognitive exercises in panic disorder patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- panic disoder patients over 18 years old
Key inclusion criteria (2 listed)
- Patients over 18 years old
- Both genders with a diagnosis of panic disorder and agoraphobia without severe comorbidities.
Key exclusion criteria (3 listed)
- Patients showing alcohol or drug dependence
- Mental retardation
- Any other severe mental disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory
Time frame: for observational studies
1 secondary outcome
Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory
Time frame: for observational studies
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 15 Oct 2008.
- Related InfoLink provided by the sponsor.
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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.
Antonio E Nardi, MD principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Panic Disorder, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
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 3 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 15 Oct 2008. 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 Brazil. 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.
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?
Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory (time frame: for observational studies). It is what the study was designed to measure, not a finding.
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 15 Oct 2008.