Anxiety DisordersPhase 3NCT00158327
Telephone-Based Care Management Program for Individuals With Anxiety Disorders
A Phase 3 study testing Telephone-based collaborative care in people with Anxiety Disorders and Panic Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will determine the impact of a telephone-based care management program for primary care patients with panic disorder or generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Anxiety Disorders, Panic Disorder
- What is being tested?
- Telephone-based collaborative care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Feb 2011
- Phase
- Phase 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
- Diagnosis of panic disorder or generalized anxiety disorder
- Score of 7 or higher on the Panic Disorder Severity Scale score OR a score of 14 or higher on the Structured Interview Guide for the Hamilton Anxiety Scale
- Life expectancy greater than 1 year
- Have a household telephone and can be contacted by phone for the duration of the study
- Able to read and write in English
Who cannot join
- Presently receiving treatment for a psychiatric disorder from a mental health specialist
- At risk for suicide
- History of bipolar disorder
- Dependence on alcohol or other substances within 6 months prior to study entry
- Organic anxiety syndromes, including those secondary to medical illness or drugs
- Unstable medical conditions that would interfere with the study
- Plan to leave their primary care source during the study or for 1 year after study completion
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The RELAX Trial: Reducing Limitations From Anxiety in Primary Care
This study will determine the impact of a telephone-based care management program for primary care patients with panic disorder or generalized anxiety disorder.
Read the detailed description
Numerous studies have shown that telephone-based collaborative care programs may be an effective way to monitor the quality of life of individuals with mental health issues such as anxiety disorders. With regular monitoring through telephone conversations, health care providers can gain information from their patients in a convenient forum. This study will determine whether a telephone-based care management program can improve anxiety symptoms, alcohol abuse, employment patterns, use of health care services, and health-related quality of life for individuals with panic disorder or generalized anxiety disorder (GAD).
Participants will be randomly assigned to receive either usual care or a telephone-based collaborative care program for 12 months. Usual care may include one or more of several different treatments such as pharmacotherapy and cognitive behavioral therapy; the treatments will be chosen by participants' physicians. Participants assigned to the telephone-based program will have a choice of what type of treatment they will receive; the choices will include pharmacotherapy, workbook training designed to help participants improve their coping skills, referral to a community mental health specialist, or some combination of these treatments.
Participants receiving usual care will continue their treatment for 12 months. After 12 months, these participants will undergo interviews and complete self-report scales for assessment of their anxiety symptoms, health care use, alcohol use, and quality of life. Their participation in the trial will end after 12 months.
Participants in the telephone intervention group will receive telephone calls 1 to 2 times every month for 12 months. During the calls, participants will be asked about their attitude toward and adherence to their treatment regimen. They will also be asked about recent episodes of anxiety they have experienced and what coping techniques they have used. Monthly follow-up calls will continue for an additional 12 months after the first year of the study; this will help determine the long-term effectiveness of the telephone-based intervention.
- Conditions
- Anxiety Disorders, Panic Disorder
- Being tested
- Telephone-based collaborative care, Usual care
- Keywords
- Primary Health Care
- Medical subject headings
- Anxiety Disorders, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based collaborative careBehavioural
Participants assigned to the telephone-based program will have a choice of what type of treatment they will receive. The choices will include pharmacotherapy, workbook training designed to help participants improve their coping skills, referral to a community mental health specialist, or some combination of these treatments. Participants will receive telephone calls one to two times every month for 12 months. During the calls, participants will be asked about their attitude toward and adherence to their treatment regimen. They will also be asked about recent episodes of anxiety they have experienced and what coping techniques they have used.
Usual careBehavioural
Usual care may include one or more of several different treatments such as pharmacotherapy and cognitive behavioral therapy; the treatments will be chosen by participants' physicians and will be delivered for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive telephone-based collaborative care Receives: Behavioral: Telephone-based collaborative care |
| 2 | Active comparator | Participants will receive usual care Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (SF-36 MCS)
Measured: Measured at Month 12
Secondary outcomes (6)
Generalized anxiety symptoms
Measured: Measured at Month 12
Panic disorder severity scale (PDSS)
Measured: Measured at Month 12
PHQ-9
Measured: Measured at Month 12
Alcohol use
Measured: Measured at Month 12
Health services utilization
Measured: Measured at Month 12
Health care costs
Measured: Measured at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startMar 2004
- Primary completionJun 2010
- Study completionFeb 2011
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 Anxiety DisordersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Bruce Rollman, University of Pittsburgh
- Investigators
- Bruce L. Rollman, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158327
- Sponsor's protocol ID
- R01MH059395
- Other IDs
- R01MH059395, RELAX, DSIR 82-SEPC
- Status last verified
- Jan 2014
- First submitted
- 7 Sep 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 12676419Behringer T, Rollman BL, Herbeck-Belnap B, Houck PR, Mazumdar S, Schwarz EB. Impact of physician counseling and perception of teratogenic risks: a survey of 96 nonpregnant women with anxiety. Prim Care Companion CNS Disord. 2011;13(2):PCC.10m01028. doi: 10.4088/PCC.10m01028.
PubMed 21977355Rollman 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
- The RELAX Trial: Reducing Limitations From Anxiety in Primary Care
- ClinicalTrials.gov ID
- NCT00158327
- Acronym / sponsor ID
- R01MH059395
- Conditions
- Anxiety Disorders, Panic Disorder
- Keywords
- Primary Health Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2004
- Primary completion
- Jun 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 12 Sep 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 impact of a telephone-based care management program for primary care patients with panic disorder or generalized anxiety disorder.
Detailed description
Numerous studies have shown that telephone-based collaborative care programs may be an effective way to monitor the quality of life of individuals with mental health issues such as anxiety disorders. With regular monitoring through telephone conversations, health care providers can gain information from their patients in a convenient forum. This study will determine whether a telephone-based care management program can improve anxiety symptoms, alcohol abuse, employment patterns, use of health care services, and health-related quality of life for individuals with panic disorder or generalized anxiety disorder (GAD).
Participants will be randomly assigned to receive either usual care or a telephone-based collaborative care program for 12 months. Usual care may include one or more of several different treatments such as pharmacotherapy and cognitive behavioral therapy; the treatments will be chosen by participants' physicians. Participants assigned to the telephone-based program will have a choice of what type of treatment they will receive; the choices will include pharmacotherapy, workbook training designed to help participants improve their coping skills, referral to a community mental health specialist, or some combination of these treatments.
Participants receiving usual care will continue their treatment for 12 months. After 12 months, these participants will undergo interviews and complete self-report scales for assessment of their anxiety symptoms, health care use, alcohol use, and quality of life. Their participation in the trial will end after 12 months.
Participants in the telephone intervention group will receive telephone calls 1 to 2 times every month for 12 months. During the calls, participants will be asked about their attitude toward and adherence to their treatment regimen. They will also be asked about recent episodes of anxiety they have experienced and what coping techniques they have used. Monthly follow-up calls will continue for an additional 12 months after the first year of the study; this will help determine the long-term effectiveness of the telephone-based intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Telephone-based collaborative careParticipants will receive telephone-based collaborative care |
| 2 | Active comparator | Behavioral: Usual careParticipants will receive usual care |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of panic disorder or generalized anxiety disorder
- Score of 7 or higher on the Panic Disorder Severity Scale score OR a score of 14 or higher on the Structured Interview Guide for the Hamilton Anxiety Scale
- Life expectancy greater than 1 year
- Have a household telephone and can be contacted by phone for the duration of the study
- Able to read and write in English
Key exclusion criteria (7 listed)
- Presently receiving treatment for a psychiatric disorder from a mental health specialist
- At risk for suicide
- History of bipolar disorder
- Dependence on alcohol or other substances within 6 months prior to study entry
- Organic anxiety syndromes, including those secondary 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 careParticipants assigned to the telephone-based program will have a choice of what type of treatment they will receive. The choices will include pharmacotherapy, workbook training designed to help participants improve their coping skills, referral to a community mental health specialist, or some combination of these treatments. Participants will receive telephone calls one to two times every month for 12 months. During the calls, participants will be asked about their attitude toward and adherence to their treatment regimen. They will also be asked about recent episodes of anxiety they have experienced and what coping techniques they have used. | Behavioural | 1 |
| Usual careUsual care may include one or more of several different treatments such as pharmacotherapy and cognitive behavioral therapy; the treatments will be chosen by participants' physicians and will be delivered for 12 months. | Behavioural | 2 |
Primary outcome
Health-related quality of life (SF-36 MCS)
Time frame: Measured at Month 12
6 secondary outcomes
Generalized anxiety symptoms
Time frame: Measured at Month 12
Panic disorder severity scale (PDSS)
Time frame: Measured at Month 12
PHQ-9
Time frame: Measured at Month 12
Alcohol use
Time frame: Measured at Month 12
Health services utilization
Time frame: Measured at Month 12
Health care costs
Time frame: Measured at Month 12
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.
- Derived from this study: PubMed 21977355Behringer T, Rollman BL, Herbeck-Belnap B, Houck PR, Mazumdar S, Schwarz EB. Impact of physician counseling and perception of teratogenic risks: a survey of 96 nonpregnant women with anxiety. Prim Care Companion CNS Disord. 2011;13(2):PCC.10m01028. doi: 10.4088/PCC.10m01028.
- 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.
Related trials for Anxiety Disorders
Recruiting
The Effect of Using Nature Sounds and Virtual Reality During the Non-Stress Test
Pregnancy - Prenatal Testing
Recruiting
Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery
Open-Heart Surgery
Active, not recruitingPhase 4
Neural Circuit Effects of Ketamine in Depression
Major Depressive Disorder
Recruiting
A Study of a One-Time Counseling Session to Help Reduce Depression, Anxiety, and Distress in People With Cancer
Breast Cancer
Not yet recruitingObservational study
Media Use, Anxiety, Sedation, and Recovery in Children Having Upper GI Endoscopy
Anesthesia, Anxiety
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 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 3 study testing Telephone-based collaborative care in people with Anxiety Disorders and Panic 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 7 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 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?
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?
Health-related quality of life (SF-36 MCS) (time frame: Measured at Month 12). 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 NCT00158327, 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.