Panic DisorderPhase 2/3NCT00102427
Improving Quality of Primary Care for Patients With Anxiety and/or Panic Disorders
A Phase 2/3 study testing Telephone-based collaborative care management in people with Panic Disorder and Anxiety Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to determine if primary care patients with panic and/or generalized anxiety disorder can benefit from a telephone-based collaborative care intervention. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Panic Disorder, Anxiety Disorder
- What is being tested?
- Telephone-based collaborative care management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2000to May 2003
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Panic disorder or generalized anxiety disorder
- A Structured Interview Guide to the Hamilton Rating Scale for Anxiety (SIGH-A) score of at least 14 for participants with generalized anxiety disorder OR Panic Disorder Severity Scale (PDSS) score of at least 7 for participants with panic disorder
- Primary care physician has agreed to participate in the study
- Speaks English and able to participate in phone assessments and information/self-management program
- Gives consent to allow research staff to notify the participant's primary care physician of diagnosis
Who cannot join
- Thoughts of suicide
- Current psychotic disorder
- Current bipolar disorder
- Alcohol or other substance disorder within the past 2 months prior to study entry
- Organic anxiety syndromes, including those due to medical illness or drugs
- Unstable medical conditions
Show all 9Show fewer
- Plans to leave current physician during the year after study start
- Life expectancy less than 1 year
- Previously enrolled in a similar panic or generalized anxiety disorder study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Improving Quality of Primary Care for Anxiety Disorders
The purpose of this study is to determine if primary care patients with panic and/or generalized anxiety disorder can benefit from a telephone-based collaborative care intervention.
Read the detailed description
Panic and generalized anxiety disorders are serious conditions that often are inadequately recognized and treated, responsible for significant morbidity, and associated with excessive health services' utilization. More effective treatment interventions that involve both primary care physicians (PCPs) and patients are necessary to manage these conditions.
Patients presenting for primary care services will be screened for panic and generalized anxiety disorders using the Primary Care Evaluation of Mental Disorder (PRIME-MD); patients and their PCPs will be informed of patients' diagnosis. Participants will then be randomly assigned to receive either a telephone-based collaborative care intervention or their PCPs' usual care.
The telephone care intervention will involve a protocol that is based on the American Psychiatric Association's and other published guidelines for treating panic disorder (PD) and generalized anxiety disorder (GAD). The care manager will assess each patient's treatment preferences for either anxiolytic pharmacotherapy, a self-management workbook, referral to a community mental health specialist, or some combination of these. The care manager will conduct periodic telephone follow-up interviews with intervention participants to inquire about anxiety symptoms, treatment adherence, review lesson plans, and any side effects they have experienced, as applicable. The care manager maintains correspondence with the PCPs of the telephone intervention participants via an electronic medical record system to rapidly relay information regarding patients' treatment and obtain the PCPs approval for initiating or adjusting pharmacotherapy according to the patient's response to treatment and protocol.
A blinded research assistant who is unaware of participants' randomization group will conduct telephone interviews with all participants to assess the effectiveness of the intervention relative to the usual care control condition. These interviews will be conducted at baseline and at 2-, 4-, 8-, and 12-months follow-up. Measures assessed include anxiety symptoms, functional status, health services utilization, and overall quality of life.
- Conditions
- Panic Disorder, Anxiety Disorder
- Being tested
- Telephone-based collaborative care management
- Keywords
- Anxiety, Panic, Generalized Anxiety Disorder
- Medical subject headings
- Panic Disorder, Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based collaborative care managementBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2005 (estimated)
- Study startJul 2000
- Study completionMay 2003
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.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Bruce L. Rollman, MD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102427
- Sponsor's protocol ID
- R01MH059395
- Other IDs
- R01MH059395
- Status last verified
- Jan 2014
- First submitted
- 29 Jan 2005
- Last updated
- 22 Jan 2014
- Results posted
- No
Publications
Rollman BL, Herbeck Belnap B, Reynolds CF, Schulberg HC, Shear MK. A contemporary protocol to assist primary care physicians in the treatment of panic and generalized anxiety disorders. Gen Hosp Psychiatry. 2003 Mar-Apr;25(2):74-82. doi: 10.1016/s0163-8343(03)00004-5.
PubMed 12676419Rollman BL, Belnap BH, Mazumdar S, Houck PR, Zhu F, Gardner W, Reynolds CF 3rd, Schulberg HC, Shear MK. A randomized trial to improve the quality of treatment for panic and generalized anxiety disorders in primary care. Arch Gen Psychiatry. 2005 Dec;62(12):1332-41. doi: 10.1001/archpsyc.62.12.1332.
PubMed 16330721Rollman BL, Fischer GS, Zhu F, Belnap BH. Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment. J Gen Intern Med. 2008 Apr;23(4):447-50. doi: 10.1007/s11606-007-0449-0.
PubMed 18373143
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Primary Care for Anxiety Disorders
- ClinicalTrials.gov ID
- NCT00102427
- Acronym / sponsor ID
- R01MH059395
- Conditions
- Panic Disorder, Anxiety Disorder
- Keywords
- Anxiety, Panic, Generalized Anxiety Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2000
- Study completion
- May 2003
- First posted
- 31 Jan 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.
The purpose of this study is to determine if primary care patients with panic and/or generalized anxiety disorder can benefit from a telephone-based collaborative care intervention.
Detailed description
Panic and generalized anxiety disorders are serious conditions that often are inadequately recognized and treated, responsible for significant morbidity, and associated with excessive health services' utilization. More effective treatment interventions that involve both primary care physicians (PCPs) and patients are necessary to manage these conditions.
Patients presenting for primary care services will be screened for panic and generalized anxiety disorders using the Primary Care Evaluation of Mental Disorder (PRIME-MD); patients and their PCPs will be informed of patients' diagnosis. Participants will then be randomly assigned to receive either a telephone-based collaborative care intervention or their PCPs' usual care.
The telephone care intervention will involve a protocol that is based on the American Psychiatric Association's and other published guidelines for treating panic disorder (PD) and generalized anxiety disorder (GAD). The care manager will assess each patient's treatment preferences for either anxiolytic pharmacotherapy, a self-management workbook, referral to a community mental health specialist, or some combination of these. The care manager will conduct periodic telephone follow-up interviews with intervention participants to inquire about anxiety symptoms, treatment adherence, review lesson plans, and any side effects they have experienced, as applicable. The care manager maintains correspondence with the PCPs of the telephone intervention participants via an electronic medical record system to rapidly relay information regarding patients' treatment and obtain the PCPs approval for initiating or adjusting pharmacotherapy according to the patient's response to treatment and protocol.
A blinded research assistant who is unaware of participants' randomization group will conduct telephone interviews with all participants to assess the effectiveness of the intervention relative to the usual care control condition. These interviews will be conducted at baseline and at 2-, 4-, 8-, and 12-months follow-up. Measures assessed include anxiety symptoms, functional status, health services utilization, and overall quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Panic disorder or generalized anxiety disorder
- A Structured Interview Guide to the Hamilton Rating Scale for Anxiety (SIGH-A) score of at least 14 for participants with generalized anxiety disorder OR Panic Disorder Severity Scale (PDSS) score of at least 7 for participants with panic disorder
- Primary care physician has agreed to participate in the study
- Speaks English and able to participate in phone assessments and information/self-management program
- Gives consent to allow research staff to notify the participant's primary care physician of diagnosis
Key exclusion criteria (9 listed)
- Thoughts of suicide
- Current psychotic disorder
- Current bipolar disorder
- Alcohol or other substance disorder within the past 2 months prior to study entry
- Organic anxiety syndromes, including those due to medical illness or drugs
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 |
|---|---|---|
| Telephone-based collaborative care management | Behavioural | – |
Primary outcome
Anxiety symptoms
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 22 Jan 2014.
- Background: PubMed 12676419Rollman BL, Herbeck Belnap B, Reynolds CF, Schulberg HC, Shear MK. A contemporary protocol to assist primary care physicians in the treatment of panic and generalized anxiety disorders. Gen Hosp Psychiatry. 2003 Mar-Apr;25(2):74-82. doi: 10.1016/s0163-8343(03)00004-5.
- Results publication: PubMed 16330721Rollman BL, Belnap BH, Mazumdar S, Houck PR, Zhu F, Gardner W, Reynolds CF 3rd, Schulberg HC, Shear MK. A randomized trial to improve the quality of treatment for panic and generalized anxiety disorders in primary care. Arch Gen Psychiatry. 2005 Dec;62(12):1332-41. doi: 10.1001/archpsyc.62.12.1332.
- Derived from this study: PubMed 18373143Rollman BL, Fischer GS, Zhu F, Belnap BH. Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment. J Gen Intern Med. 2008 Apr;23(4):447-50. doi: 10.1007/s11606-007-0449-0.
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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.
Bruce L. Rollman, MD, MPH principal investigator
University of Pittsburgh
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 Telephone-based collaborative care management in people with Panic Disorder and Anxiety Disorder, run by University of Pittsburgh 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 5 inclusion and 9 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 22 Jan 2014. 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?
Anxiety symptoms. 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 NCT00102427, 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 22 Jan 2014.