Panic DisorderPhase 2/3NCT00128388
Psychodynamic Therapy for Treating Panic Disorder
A Phase 2/3 study testing PFPP and ART in people with Panic Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This study will determine the effectiveness of a manualized form of brief psychodynamic psychotherapy in comparison with applied relaxation training in treating adults with panic disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- PFPP and ART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Jul 2005
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-55 years old
- Primary DSM-IV panic disorder with or without agoraphobia
- Severity 5/8 minimum on the Anxiety Disorders Interview Schedule
Who cannot join
- Psychosis
- Unstable medication dosage
- Unwilling to discontinue ongoing psychotherapy
- Organic mental syndrome
- Substance use or abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Psychodynamic Psychotherapy vs. Applied Relaxation for Panic Disorder
This study will determine the effectiveness of a manualized form of brief psychodynamic psychotherapy in comparison with applied relaxation training in treating adults with panic disorder.
Read the detailed description
This is a randomized controlled trial of a manualized form of brief psychodynamic psychotherapy in comparison with applied relaxation training, a less active form of treatment in other studies, for adults with primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) panic disorder.
Forty nine patients who have signed written consent who have primary DSM-IV panic disorder have been entered into the study. Randomization has been stratified by presence of major depression and use of psychoactive, anti-panic medications. Medications, if present, have been held constant. All patients have received 24 sessions of either psychodynamic psychotherapy, or applied relaxation training for panic disorder. This study is currently closed for recruitment, although final follow-up assessments have yet to be completed.
- Conditions
- Panic Disorder
- Being tested
- PFPP, ART
- Keywords
- panic disorder,, psychodynamic psychotherapy,, efficacy trial
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFPPOther
Also called Psychodynamic psychotherapy
Psychoanalytic Psychotherapy for panic disorder
ARTOther
Also called Applied Relaxation Training, Behavioral Therapy
Applied Relaxation Training
| Study group | Role | What they receive |
|---|---|---|
| 1 PFPP | Experimental | Panic Focused Psychodynamic Psychotherapy Receives: Other: PFPP |
| 2 ART | Active comparator | Applied Relaxation Training Receives: Other: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDSS (panic disorder severity scale)
Measured: termination, 2, 4, 6, 12 month f/u
Secondary outcomes (3)
SDS (Sheehan disability scale)
Measured: termination, 2, 4, 6, 12 month f/u
HARS (Hamilton anxiety rating scale)
Measured: termination, 2, 4, 6, 12 month f/u
HDRS (Hamilton depression rating scale)
Measured: termination, 2, 4, 6, 12 month f/u
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startFeb 2000
- Primary completionJan 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Barbara Milrod, M.D., Principal investigator, Weill Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128388
- Sponsor's protocol ID
- K23MH001849
- Other IDs
- K23MH001849, DSIR AT-CD
- Status last verified
- Jun 2013
- First submitted
- 5 Aug 2005
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
PubMed 32880104Klass ET, Milrod BL, Leon AC, Kay SJ, Schwalberg M, Li C, Markowitz JC. Does interpersonal loss preceding panic disorder onset moderate response to psychotherapy? An exploratory study. J Clin Psychiatry. 2009 Mar;70(3):406-11. doi: 10.4088/jcp.08m04248. Epub 2008 Nov 18.
PubMed 19026262Milrod 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Psychodynamic Psychotherapy vs. Applied Relaxation for Panic Disorder
- ClinicalTrials.gov ID
- NCT00128388
- Acronym / sponsor ID
- K23MH001849
- Conditions
- Panic Disorder
- Keywords
- panic disorder,, psychodynamic psychotherapy,, efficacy trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2000
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 9 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effectiveness of a manualized form of brief psychodynamic psychotherapy in comparison with applied relaxation training in treating adults with panic disorder.
Detailed description
This is a randomized controlled trial of a manualized form of brief psychodynamic psychotherapy in comparison with applied relaxation training, a less active form of treatment in other studies, for adults with primary Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) panic disorder.
Forty nine patients who have signed written consent who have primary DSM-IV panic disorder have been entered into the study. Randomization has been stratified by presence of major depression and use of psychoactive, anti-panic medications. Medications, if present, have been held constant. All patients have received 24 sessions of either psychodynamic psychotherapy, or applied relaxation training for panic disorder. This study is currently closed for recruitment, although final follow-up assessments have yet to be completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 PFPP | Experimental | Other: PFPPPanic Focused Psychodynamic Psychotherapy |
| 2 ART | Active comparator | Other: ARTApplied Relaxation Training |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-55 years old
- Primary DSM-IV panic disorder with or without agoraphobia
- Severity 5/8 minimum on the Anxiety Disorders Interview Schedule
Key exclusion criteria (5 listed)
- Psychosis
- Unstable medication dosage
- Unwilling to discontinue ongoing psychotherapy
- Organic mental syndrome
- Substance use or abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFPPAlso: Psychodynamic psychotherapyPsychoanalytic Psychotherapy for panic disorder | Other | 1 PFPP |
| ARTAlso: Applied Relaxation Training, Behavioral TherapyApplied Relaxation Training | Other | 2 ART |
Primary outcome
PDSS (panic disorder severity scale)
Time frame: termination, 2, 4, 6, 12 month f/u
3 secondary outcomes
SDS (Sheehan disability scale)
Time frame: termination, 2, 4, 6, 12 month f/u
HARS (Hamilton anxiety rating scale)
Time frame: termination, 2, 4, 6, 12 month f/u
HDRS (Hamilton depression rating scale)
Time frame: termination, 2, 4, 6, 12 month f/u
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
- Derived from this study: PubMed 32880104Gibbon S, Khalifa NR, Cheung NH, Vollm BA, McCarthy L. Psychological interventions for antisocial personality disorder. Cochrane Database Syst Rev. 2020 Sep 3;9(9):CD007668. doi: 10.1002/14651858.CD007668.pub3.
- Derived from this study: PubMed 19026262Klass ET, Milrod BL, Leon AC, Kay SJ, Schwalberg M, Li C, Markowitz JC. Does interpersonal loss preceding panic disorder onset moderate response to psychotherapy? An exploratory study. J Clin Psychiatry. 2009 Mar;70(3):406-11. doi: 10.4088/jcp.08m04248. Epub 2008 Nov 18.
- Derived from this study: PubMed 17592913Milrod 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.
Related trials for Panic Disorder
Not yet recruiting
A Clinical Trial to Evaluate the Efficacy and Safety of Meltz, a Digital Therapeutic Device, for Improving Panic Symptoms in Patients With Panic Disorder
Panic Disorder, Agoraphobia
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Active, not recruiting
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder in Children, Anxiety Disorder of Childhood
Recruiting
Qigong and Multicomponent Exercise in Panic Disorder
Panic Disorder, Panic Disorder (With or Without Agoraphobia)
Recruiting
Anxiety Skills Study
Anxiety, Anxiety Acute
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Milrod, M.D. principal investigator
Weill Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PFPP and ART in people with Panic Disorder, run by Weill Medical College of Cornell University at 1 site 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 3 inclusion and 5 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 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PDSS (panic disorder severity scale) (time frame: termination, 2, 4, 6, 12 month f/u). 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 NCT00128388, which also lists 3 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 27 Jun 2013.