跳至主要内容
临床试验/NCT01025908
NCT01025908已完成不适用

Cognitive-behavioural Therapyin Panic Disorder: the Preparation of Patients With Panic Disorder for Interoceptive and in Vivo Agoraphobic Exposure

Universidade Federal do Rio de Janeiro2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Number of panic attacks

研究概览

简要总结

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.

详细描述

The patients with PDA were diagnosed by medical psychiatrists from the team at the Respiration and Panic Laboratory of Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro (IPUB/UFRJ), INCT Translational Medicine, according to the criteria of diagnostic of the Manual of Diagnostic and Statistics of Mental Disorder (DSM-IV-TR, 2002b) and according to the evaluation instrument SCID-I (Structured Clinical Interview Diagnostic) (First et al, 1997). The sample consisted of 50 voluntary patients divided in two Groups. The 1st Group, made up of 25 individuals, received 10 sessions of CBT. The 2nd Group, "control", also consisted of 25 patients, who received just supportive psychotherapy.

With a view to comparing the results of the Groups after the interventions, the following evaluation instruments were applied at the beginning and at the end of the research: Beck Anxiety Inventory (Beck et al, 1998a); State-Trait Anxiety Inventory (Spielberg et al, 1970); Sheehan Disability Scale (Sheeham, 1983a); Global Assessment of Functioning (AXIS V) (DSM-IV-TR, 2002c); questionnaire of fears and phobias (Mark & Mathews, 1979); questionnaire of cognitive agoraphobias( Chambless, 1984a); questionnaire of body sensations (Chambless, 1984b) and Panic and Agoraphobia Scale (Bandelow, 1999a).

The criteria for inclusion in the research was patients over 18 years old of both sexes with a diagnosis of PDA, with no serious comorbidities. The patients that presented alcohol or drug dependency, mental retardation or serious mental disorders were excluded from the research.

The patients who agreed to participate in the study, signed a "Term of Free and Clarified Consent" and were made aware of all the procedures undertaken, approved by the Committee of Ethics for the research IPUB/UFRJ.

In the evaluation of the tests the Chi-square tests ( χ2 ) or ANOVA, depending on the type of variable measure, always with 95% of Confidence, or P-Value ≤ 0,05. In the characterization of the Groups, the tests were undertaken with the values identified at the beginning of the treatment. Thus, the efficiency of the initiatives undertaken could be perceived. The objective was to identify the significant statistical differences, between the initial and final results of the tests.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The criteria for inclusion in the research was patients over 18 years old of both sexes with a diagnosis of PDA, with no serious comorbidities.

排除标准

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

结局指标

主要结局

Number of panic attacks

时间窗: 3 months

次要结局

  • Decrease agoraphobic symptoms(3 months)

研究者

申办方类型
Other

研究点 (2)

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