Clinical trial NCT00772746: Cognitive Behavioral Therapy in Panic Disorder
Official title: Effectiveness of Specific Model of Cognitive-Behavioral Therapy in Panic Disorder Patients With Agoraphobia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Panic Disorder
Keywords: panic
respiration
anxiety
exercise
cognition
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: panic disoder patients over 18 years old

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.

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 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.

Primary outcomes:
measure: Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory
timeFrame: for observational studies
Secondary outcomes:
measure: Beck anxiety inventory Sheehan disability scale fear and phobia questionnaire agoraphobia cognitions questionnaire panic and agoraphobia scale mobility inventory
timeFrame: for observational studies
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Rio de Janeiro
state: RJ
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Antonio E Nardi, MD
role: PRINCIPAL_INVESTIGATOR
References: