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CompletedNCT00105885TelepsychUpdated Feb 10, 2014

Telephone Care as a Substitute for Routine Psychiatric Medication

An interventional study of telephone care in Major Depression, Posttraumatic Stress Disorders and Anxiety Disorders, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-10.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
324
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to answer the following questions: (1) Does substituting brief, scheduled, clinician-initiated telephone calls (telephone care) for routine psychiatric medication management visits reduce overall healthcare utilization? (2) Is substituting brief, scheduled, clinician-initiated telephone calls (telephone care) for routine psychiatric medication management visits as effective as routine care?

Read the detailed description

Telemedicine uses communications technologies to provide health care when distance separates participants. Applied to general medical care practice, telemedicine is associated with improved continuity of care, cost-effectiveness, and improved service quality. To date, all evaluations of telepsychiatry have concentrated on video technology. The telephone is more readily available and less expensive communication technology that has not been evaluated as a method of health services delivery in the medication management of stable psychiatric outpatients. We will enroll 346 psychiatrically stable subjects, who carry a diagnosis of major depression, post-traumatic stress disorder (PTSD) or non-PTSD anxiety disorder. We will use a balanced randomization strategy to assign subjects to routine care or telephone care for a two-year period within each provider panel. Patients randomized to receive routine care will be scheduled to see their psychiatric medication provider at the recommended interval. Patients randomized to receive telephone care will be scheduled to see their provider at twice the recommended clinic visit interval, and two ten-minute telephone contacts will be scheduled at a specific time at standard 0.67 and 1.3 times the multiple of the recommended interval. At two years, we will use ten data sources to compare two primary outcomes (total VHA health services utilization and mental health component scores from the SF-12-V) as well as VHA costs, imputed non-VHA costs, patient and provider satisfaction, medication compliance and diagnosis specific outcomes.

02

Conditions studied

  • Major Depression
  • Posttraumatic Stress Disorders
  • Anxiety Disorders

Keywords

  • Telephone
  • Telemedicine
  • Psychopharmacology
03

In context

Anxiety Disorders

4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.

This study's enrollment of 324 is above the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients will be eligible for this study if they carry a diagnosis of major depression, Post-traumatic Stress Disorder (PTSD), or non-PTSD anxiety disorders.
  • They must be psychiatrically stable subjects with a Global Assessment of Functioning scale score of >50, no psychiatric hospitalizations in the previous six months, and no active substance abuse disorders.

Exclusion criteria

Exclusion Criteria:

  • Psychiatric hospitalization within 6 months prior to study entry.
  • Visit interval >1 year.
  • Lack of telephone access.
  • Inability to use a telephone.
  • GAF\<50.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
324 participants (actual)

Study arms

  • Experimental
    Arm 1

    Patients randomized to receive telephone care will be scheduled to see their provider at twice the recommended clinical visit interval, and two ten-minute telephone contacts will be scheduled at a specific time at standard 0.67 and 1.3 times the multiple of the recommended interval.

    Procedure: telephone care

  • No intervention
    Arm 2

    Patients randomized to receive routine care will be scheduled to see their psychiatric medication provider at the recommended interval.

Interventions

  • Proceduretelephone care

    Patients randomized to receive telephone care will be scheduled to see their provider at twice the recommended clinical visit interval, and two ten-minute telephone contacts will be scheduled at a specific time at standard 0.67 and 1.3 times the multiple of the recommended interval.

06

What researchers measure

Primary outcomes

  1. Healthcare utilization (VHA and non-VHA patient visits); patient time spent obtaining care (including travel time); time provider spends in direct patient care.

    Time frame: Continuous

Secondary outcomes

  1. Patient satisfaction at baseline, midpoint, end of study; provider satisfaction at baseline, midpoint, end of study; patient medication compliance; SF12V and brief symptom checklist scores

    Time frame: baseline, 6 months, 12 months, 18 months, 24 months

  2. SF12V and brief symptom checklist scores

    Time frame: baseline, 6 months, 18 months, 24 months

  3. patient medication compliance

    Time frame: two month intervals

  4. provider satisfaction

    Time frame: baseline, midpoint, and end of study

07

Study locations

1 site
  • VA Medical & Regional Office Center, White River
    White River Junction, Vermont 05009-0001, United States
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References and documents

Publications

  • Pomerantz A, Cole BH, Watts BV, Weeks WB. Improving efficiency and access to mental health care: combining integrated care and advanced access. Gen Hosp Psychiatry. 2008 Nov-Dec;30(6):546-51. doi: 10.1016/j.genhosppsych.2008.09.004. Epub 2008 Oct 5. PubMed 19061681 ↗
  • Morden NE, Mistler LA, Weeks WB, Bartels SJ. Health care for patients with serious mental illness: family medicine's role. J Am Board Fam Med. 2009 Mar-Apr;22(2):187-95. doi: 10.3122/jabfm.2009.02.080059. PubMed 19264942 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00105885
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Mar 18, 2005
Start date
Nov 2003
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Feb 10, 2014

Study contacts

Amy E. Wallace, MD MPH
principal investigator · VA Medical & Regional Office Center, White River

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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