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Completed

NCT Number: NCT00353470

Comparison of Psychotherapy Programs to Treat Panic Disorder

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

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Key information

Conditions

Anxiety Disorders Agoraphobia Mental Disorders Panic Disorder Phobic Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Weill Medical College of Cornell University, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

CBT for panic disorder will include 19 to 24 sessions over 12 weeks.

Other names: Panic control treatment

Applied relaxation training (ART)

Behavioral

ART with exposure protocol will include 19 to 24 sessions over 12 weeks.

Other names: ART

Panic focused psychodynamic psychotherapy (PFPP)

Behavioral

PFPP will include 19 to 24 sessions over 12 weeks.

Primary outcomes

  1. Panic Disorder Severity Scale

    Time frame: 12 weeks

    A composite score of panic severity. High value = 28, lowest value =0. Higher=worse

Secondary outcomes

  1. Sheehan Disability Scale

    Time frame: 12 weeks

    Level of psychosocial functional impairment. highest value=30, lowest value =0, higher numbers indicate greater dysfunction

  2. Clinical Global Impressions Scale

    Time frame: 12 weeks

    Clinical assessment of severity of impairment. Minimum value=1, maximum value =6; high scores worse

  3. Hamilton Depression Rating Scale

    Time frame: 12 weeks

    Level of state depression. scale 0-81, 0 symptom free, 81 worst severity

  4. Hamilton Anxiety Rating Scale

    Time frame: 12 weeks

    level of state anxiety. 0=symptom free, 56 most severe

  5. Anxiety Disorder Sensitivity Index

    Time frame: 12 weeks

    Anxiety disorder sensitivity index measures Sensitivity to physical symptoms of anxiety (scores range from 0-64). 0= no anxiety, 64 =maximum anxiety

  6. Brief Body Sensitivity Interpretation Questionnaire (BBSIQ)

    Time frame: 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

  7. Panic-Specific Reflective Function

    Time frame: 12 weeks

    Ability to reflect on the emotional meaning of panic symptoms. scored -1 to 9, high numbers better

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Dynamic Treatment vs. CBT for Panic Disorder

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2006
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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