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Cognitive Behavioral Therapy in Panic Disorder (CBT)

This study has been completed.
Sponsor:
Information provided by:
Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT00772746
First received: October 14, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition
Panic Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effectiveness of Specific Model of Cognitive-Behavioral Therapy in Panic Disorder Patients With Agoraphobia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of Rio de Janeiro:

Primary Outcome Measures:
  • Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory [ Time Frame: for observational studies ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory [ Time Frame: for observational studies ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

None retained


Enrollment: 50
Study Start Date: March 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
exercise
Respiratory and cognitive exercises in panic disorder patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

panic disoder patients over 18 years old

Criteria

Inclusion Criteria:

  • Patients over 18 years old
  • Both genders with a diagnosis of panic disorder and agoraphobia without severe comorbidities.

Exclusion Criteria:

  • Patients showing alcohol or drug dependence
  • Mental retardation
  • Any other severe mental disorder.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772746

Locations
Brazil
Universidade Federal do Rio de Janeiro
Rio de Janeiro, RJ, Brazil, 22291-140
Sponsors and Collaborators
Federal University of Rio de Janeiro
Investigators
Principal Investigator: Antonio E Nardi, MD Federal University of Rio de Janeiro
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Antonio Egidio Nardi, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT00772746     History of Changes
Other Study ID Numbers: ALSK 021, ALK-123456-1
Study First Received: October 14, 2008
Last Updated: October 14, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio de Janeiro:
panic
respiration
anxiety
exercise
cognition

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013