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AzTrials

Anxiety DisordersPhase 3NCT00353470

Comparison of Psychotherapy Programs to Treat Panic Disorder

A Phase 3 study testing Cognitive behavioral therapy, Applied relaxation training (ART) and Panic focused psychodynamic psychotherapy (PFPP) in people with Anxiety Disorders and Panic Disorder, run by Weill Medical College of Cornell University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Anxiety Disorders, Panic Disorder, Agoraphobia
What is being tested?
Cognitive behavioral therapy, Applied relaxation training (ART) and Panic focused psychodynamic psychotherapy (PFPP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
2 sitesUnited States
Study dates
Sep 2006to Sep 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Weill Medical College of Cornell University

    New York, New York, 10065

  • University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Dynamic Treatment vs. CBT for Panic Disorder

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

Read the 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.

Being tested
Cognitive behavioral therapy, Applied relaxation training (ART), Panic focused psychodynamic psychotherapy (PFPP)
Keywords
PD, CBT, PFPP
Medical subject headings
Anxiety Disorders, Panic Disorder, Agoraphobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive behavioral therapyBehavioural

    Also called Panic control treatment

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

  • Applied relaxation training (ART)Behavioural

    Also called ART

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

  • Panic focused psychodynamic psychotherapy (PFPP)Behavioural

    PFPP will include 19 to 24 sessions over 12 weeks.

Study groups in NCT00353470
Study groupRoleWhat they receive
1ExperimentalParticipants will receive panic focused psychodynamic psychotherapy for 12 weeks
Receives: Behavioral: Panic focused psychodynamic psychotherapy (PFPP)
2Active comparatorParticipants will receive cognitive behavioral therapy-panic control treatment for 12 weeks
Receives: Behavioral: Cognitive behavioral therapy
3Active comparatorParticipants will receive applied relaxation training for 12 weeks
Receives: Behavioral: Applied relaxation training (ART)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Panic Disorder Severity Scale

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

    Measured: 12 weeks

Secondary outcomes (7)

  1. Sheehan Disability Scale

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

    Measured: 12 weeks

  2. Clinical Global Impressions Scale

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

    Measured: 12 weeks

  3. Hamilton Depression Rating Scale

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

    Measured: 12 weeks

  4. Hamilton Anxiety Rating Scale

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

    Measured: 12 weeks

  5. Anxiety Disorder Sensitivity Index

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

    Measured: 12 weeks

  6. Brief Body Sensitivity Interpretation Questionnaire (BBSIQ)

    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

    Measured: 12 weeks

  7. Panic-Specific Reflective Function

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2006 (estimated)
  2. Study startSep 2006
  3. Primary completionMar 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00353470
Sponsor's protocol ID
R01MH070918
Other IDs
R01MH070664
Status last verified
Nov 2022
First submitted
14 Jul 2006
Last updated
23 Dec 2022
Data monitoring committee
Yes

Publications

  • Milrod B, Leon AC, Busch F, Rudden M, Schwalberg M, Clarkin J, Aronson A, Singer M, Turchin W, Klass ET, Graf E, Teres JJ, Shear MK. A randomized controlled clinical trial of psychoanalytic psychotherapy for panic disorder. Am J Psychiatry. 2007 Feb;164(2):265-72. doi: 10.1176/ajp.2007.164.2.265.

    PubMed 17267789

  • Milrod BL, Leon AC, Barber JP, Markowitz JC, Graf E. Do comorbid personality disorders moderate panic-focused psychotherapy? An exploratory examination of the American Psychiatric Association practice guideline. J Clin Psychiatry. 2007 Jun;68(6):885-91. doi: 10.4088/jcp.v68n0610.

    PubMed 17592913

  • Milrod B, Chambless DL, Gallop R, Busch FN, Schwalberg M, McCarthy KS, Gross C, Sharpless BA, Leon AC, Barber JP. Psychotherapies for Panic Disorder: A Tale of Two Sites. J Clin Psychiatry. 2016 Jul;77(7):927-35. doi: 10.4088/JCP.14m09507.

    PubMed 27464313

  • Keefe JR, Chambless DL, Barber JP, Milrod BL. Predictors and moderators of treatment dropout in cognitive-behavioral and psychodynamic therapies for panic disorder. Psychother Res. 2021 Apr;31(4):432-442. doi: 10.1080/10503307.2020.1784487. Epub 2020 Jun 25.

    PubMed 32584211

  • Barber JP, Milrod B, Gallop R, Solomonov N, Rudden MG, McCarthy KS, Chambless DL. Processes of therapeutic change: Results from the Cornell-Penn Study of Psychotherapies for Panic Disorder. J Couns Psychol. 2020 Mar;67(2):222-231. doi: 10.1037/cou0000417.

    PubMed 32105128

  • Keefe JR, Huque ZM, DeRubeis RJ, Barber JP, Milrod BL, Chambless DL. In-session emotional expression predicts symptomatic and panic-specific reflective functioning improvements in panic-focused psychodynamic psychotherapy. Psychotherapy (Chic). 2019 Dec;56(4):514-525. doi: 10.1037/pst0000215. Epub 2019 Mar 14.

    PubMed 30869969

  • Solomonov N, Falkenstrom F, Gorman BS, McCarthy KS, Milrod B, Rudden MG, Chambless DL, Barber JP. Differential effects of alliance and techniques on Panic-Specific Reflective Function and misinterpretation of bodily sensations in two treatments for panic. Psychother Res. 2020 Jan;30(1):97-111. doi: 10.1080/10503307.2019.1585591. Epub 2019 Mar 1.

    PubMed 30821630

  • Suarez-Jimenez B, Zhu X, Lazarov A, Mann JJ, Schneier F, Gerber A, Barber JP, Chambless DL, Neria Y, Milrod B, Markowitz JC. Anterior hippocampal volume predicts affect-focused psychotherapy outcome. Psychol Med. 2020 Feb;50(3):396-402. doi: 10.1017/S0033291719000187. Epub 2019 Feb 18.

    PubMed 30773148

  • McCarthy KS, Chambless DL, Solomonov N, Milrod B, Barber JP. Twelve-Month Outcomes Following Successful Panic-Focused Psychodynamic Psychotherapy, Cognitive-Behavioral Therapy, or Applied Relaxation Training for Panic Disorder. J Clin Psychiatry. 2018 Sep 11;79(5):17m11807. doi: 10.4088/JCP.17m11807.

    PubMed 30256548

  • Solomonov N, McCarthy KS, Gorman BS, Barber JP. The Multitheoretical List of Therapeutic Interventions - 30 items (MULTI-30). Psychother Res. 2019 Jul;29(5):565-580. doi: 10.1080/10503307.2017.1422216. Epub 2018 Jan 16.

    PubMed 29336228

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cognitive behavioral therapy, Applied relaxation training (ART) and Panic focused psychodynamic psychotherapy (PFPP) in people with Anxiety Disorders and Panic Disorder, run by Weill Medical College of Cornell University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Panic Disorder Severity Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00353470, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.

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