NCT01025908

Brief Summary

The objective of this study in cognitive-behavioural therapy (CBT) was to demonstrate the preparation of the patient with panic disorder for agoraphobic exposures. The focus of the work consisted of interoceptive exposures, in vivo, of body sensations themselves, to feared places and situations. The sample consisted of 50 individuals. Group 1 undertook 10 weekly, individual sessions of CBT of one hour duration. Group 2, control, was just follow-up with supportive therapy. The procedures used for the exposures, especially for induction symptom exercises, were considered essential in the preparation of patients with panic disorder, to be able to face up to panic attacks and subsequent agoraphobic situations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 4, 2009

Completed
Last Updated

February 1, 2010

Status Verified

December 1, 2009

Enrollment Period

3 months

First QC Date

December 3, 2009

Last Update Submit

January 29, 2010

Conditions

Panic DisorderAgoraphobia

Keywords

psychotherapypanic disorderanxietybehaviorcognition

Outcome Measures

Primary Outcomes (1)

  • Number of panic attacks

    3 months

Secondary Outcomes (1)

  • Decrease agoraphobic symptoms

    3 months

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

25 panic disorder patients

Behavioral: Psychotherapy

Supportive psychotherapy

ACTIVE COMPARATOR

25 panic disorder agoraphobia

Behavioral: Supportative psychotherapy

Interventions

PsychotherapyBEHAVIORAL

Cognitive Behavioral Therapy

Also known as: Cognitive Behavior psychotherapy
Cognitive Behavioral Therapy
Supportative psychotherapyBEHAVIORAL

Supportative psychotherapy

Also known as: non-specific psychotherapy
Supportive psychotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • The patients that presented alcohol or drug dependency, mental retardation or serious mental disorders were excluded from the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Psychiatry - UFRJ

Rio de Janeiro, Rio de Janeiro, 22290140, Brazil

Location

MeSH Terms

Conditions

Panic DisorderAgoraphobiaAnxiety DisordersBehavior

Interventions

PsychotherapyCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersPhobic Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and ActivitiesBehavior Therapy

Study Officials

  • Antonio E Nardi, MD

    Universidade Federal do Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 4, 2009

Study Start

May 1, 2006

Primary Completion

August 1, 2006

Study Completion

April 1, 2007

Last Updated

February 1, 2010

Record last verified: 2009-12

Locations

BR(1)