NCT00158327

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

6.3 years

First QC Date

September 7, 2005

Last Update Submit

January 21, 2014

Conditions

Anxiety DisordersPanic Disorder

Keywords

Primary Health Care

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life (SF-36 MCS)

    Measured at Month 12

Secondary Outcomes (6)

  • Generalized anxiety symptoms

    Measured at Month 12

  • Panic disorder severity scale (PDSS)

    Measured at Month 12

  • PHQ-9

    Measured at Month 12

  • Alcohol use

    Measured at Month 12

  • Health services utilization

    Measured at Month 12

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Participants will receive telephone-based collaborative care

Behavioral: Telephone-based collaborative care

2

ACTIVE COMPARATOR

Participants will receive usual care

Behavioral: Usual care

Interventions

Telephone-based collaborative careBEHAVIORAL

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.

1
Usual careBEHAVIORAL

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.

2

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (3)

  • 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.

    PMID: 12676419BACKGROUND

  • Behringer 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.

    PMID: 21977355DERIVED

  • Rollman 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.

    PMID: 18373143DERIVED

MeSH Terms

Conditions

Anxiety DisordersPanic Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Bruce L. Rollman, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

March 1, 2004

Primary Completion

June 1, 2010

Study Completion

February 1, 2011

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

US(1)