CBT: Cognitive Behavioral Therapy in Panic Disorder

Sponsor
Universidade Federal do Rio de Janeiro (Other)
Overall Status
Completed
CT.gov ID
NCT00772746
Collaborator
(none)
50
1
12
4.2

Study Details

Study Description

Brief 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. 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 or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Effectiveness of Specific Model of Cognitive-Behavioral Therapy in Panic Disorder Patients With Agoraphobia
    Study Start Date :
    Mar 1, 2006
    Actual Primary Completion Date :
    Mar 1, 2007
    Actual Study Completion Date :
    Mar 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    exercise

    Respiratory and cognitive exercises in panic disorder patients.

    Outcome Measures

    Primary Outcome Measures

    1. Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory [for observational studies]

    Secondary Outcome Measures

    1. Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory [for observational studies]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Universidade Federal do Rio de Janeiro Rio de Janeiro RJ Brazil 22291-140

    Sponsors and Collaborators

    • Universidade Federal do Rio de Janeiro

    Investigators

    • Principal Investigator: Antonio E Nardi, MD, Universidade Federal do Rio de Janeiro

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00772746
    Other Study ID Numbers:
    • ALSK 021
    • ALK-123456-1
    First Posted:
    Oct 15, 2008
    Last Update Posted:
    Oct 15, 2008
    Last Verified:
    Oct 1, 2008
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 15, 2008