Comparison of Psychotherapy Programs to Treat Panic Disorder

Phase 3

Completed

• Conditions: Anxiety Disorders; Panic Disorder; Agoraphobia
• Interventions: Behavioral: Applied relaxation training (ART); Behavioral: Panic focused psychodynamic psychotherapy (PFPP); Behavioral: Cognitive behavioral therapy

• Registration Number: NCT00353470
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

This study will determine the relative effectiveness of three psychotherapies in treating people with a panic disorder.

Detailed Description

Panic disorder (PD) is a debilitating anxiety disorder. It is characterized by unexpected and repeated episodes of intense fear, accompanied by serious physical symptoms, such as chest pain, heart palpitations, shortness of breath, dizziness, or abdominal stress. Available treatments for PD include medication therapy and cognitive behavioral therapy (CBT), a type of psychotherapy that teaches people how to view panic attacks differently and how to reduce anxiety. Approximately 30% of patients refuse medication, however, and nearly 50% do not achieve remission with CBT alone. Therefore, there is a pressing need for additional non-pharmacologic treatment methods. Panic-focused psychodynamic psychotherapy (PFPP) and applied relaxation training (ART) are among some of the other available treatments for PD. During ART, individuals are taught to relax their muscles while being exposed to increasingly frightening situations. PFPP combines elements of CBT with other, more extensive approaches aimed at determining the anxiety's origin and at finding ways to reduce it. This study will compare the effectiveness of PFPP, CBT, and ART in treating PD.

Participants in this single blind study will be randomly assigned to receive PFPP, CBT, or ART for 12 weeks. All participants will attend between 19 and 24 treatment sessions over the course of the study. Upon completing the study, participants will attend monthly follow-up visits for an additional 12 months. Participants assigned to ART who have not responded by the end of treatment may opt to receive PFPP or CBT. Outcomes will be assessed using a variety of scales to determine depression and anxiety symptoms.

Study Timeline

• Study First Submitted: 2006-07-14
• Study First Submitted QC: 2006-07-14
• Study First Posted: 2006-07-18
• Study Start: 2006-09
• Primary Completion: 2012-03
• Study Completion: 2012-09
• Status Verified: 2022-11
• Results First Submitted: 2022-11-02
• Results First Submitted QC: 2022-11-30
• Last Update Submitted: 2022-11-30
• Results First Posted: 2022-12-23
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• Meets DSM-IV diagnosis criteria for primary PD with or without agoraphobia
• History of at least one spontaneous panic attack per week within the month prior to study entry

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Exclusion Criteria

• Active substance dependence within 6 months prior to study entry
• Lifetime history of any psychotic disorder, including bipolar disorder
• Acutely suicidal

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Applied relaxation training (ART)	Participants will receive applied relaxation training for 12 weeks
1	Panic focused psychodynamic psychotherapy (PFPP)	Participants will receive panic focused psychodynamic psychotherapy for 12 weeks
2	Cognitive behavioral therapy	Participants will receive cognitive behavioral therapy-panic control treatment for 12 weeks

Primary Outcome Measures

Name	Time	Method
Panic Disorder Severity Scale	12 weeks	A composite score of panic severity. High value = 28, lowest value =0. Higher=worse

Secondary Outcome Measures

Name	Time	Method
Sheehan Disability Scale	12 weeks	Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction
Anxiety Disorder Sensitivity Index	12 weeks	Anxiety disorder sensitivity index measures Sensitivity to physical symptoms of anxiety (scores range from 0-64). 0= no anxiety, 64 =maximum anxiety
Panic-Specific Reflective Function	12 weeks	Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better
Hamilton Depression Rating Scale	12 weeks	Level of state depression. scale 0-81, 0 symptom free, 81 worst severity
Brief Body Sensitivity Interpretation Questionnaire (BBSIQ)	12 weeks	The BBSIQ measures how physically sensitive the person is to physical symptoms of anxiety; (scores range 0-63) 0= no anxiety; 63= highest levels of physical anxiety
Clinical Global Impressions Scale	12 weeks	Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse
Hamilton Anxiety Rating Scale	12 weeks	level of state anxiety. 0=symptom free, 56 most severe

Trial Locations

Locations (2)

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

University of Pennsylvania School of Medicine; 🇺🇸 Philadelphia, Pennsylvania, United States