NCT00466323

Brief Summary

The purpose of this study is to learn how to help veterans play a stronger role in shaping their mental health care. Specifically we want to see if we can help veterans improve their mental health treatment by helping them decide if they want to involve family in their mental health treatment, and if so, how. The study will compare a "family member provider" program to an "enhanced treatment as usual approach" in achieving these goals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

April 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

October 20, 2014

Completed
Last Updated

April 24, 2015

Status Verified

August 1, 2014

Enrollment Period

3.7 years

First QC Date

April 24, 2007

Results QC Date

October 9, 2014

Last Update Submit

April 6, 2015

Conditions

SchizophreniaSchizoaffective DisorderMajor Depression

Keywords

Mental IllnessSchizophreniaEducationFamily member treatmentActive psychoses

Outcome Measures

Primary Outcomes (2)

  • Family-Clinician Contact (Including Contact With FMPO Clinician)

    Chart review looking at the any clinician contact with veteran's family members

    Within 6 months of intervention

  • Family-Clinician Contact (Not Including Notes From FMPO Clinicians)

    Chart review looking at the any clinician contact with veteran's family members

    Within 6 months of intervention

Secondary Outcomes (2)

  • Consumer's Recovery Rating - MHRM Total Score

    Within 6 months of intervention

  • Consumer's Recovery Rating - MHRM - Overcoming Stuckness Sub Score

    Within 6 month of the intervention

Study Arms (2)

FMPO Condition

EXPERIMENTAL

Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.

Behavioral: Family Member Provider Outreach

Enhanced treatment as usual (e-TAU)

ACTIVE COMPARATOR

Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.

Behavioral: Enhanced treatment as usual (e-TAU)

Interventions

Family Member Provider OutreachBEHAVIORAL

Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.

FMPO Condition
Enhanced treatment as usual (e-TAU)BEHAVIORAL

Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.

Enhanced treatment as usual (e-TAU)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • Diagnosis of a psychotic disorder in keeping with criteria established by the Serious Mental Illness Treatment Research and Evaluation Center (SMITREC){{646}} (schizophrenic disorders (295.0-295.9), affective psychoses (296.1, 296.4-296.8) and other psychotic diagnoses (297.0-298.9)) or diagnosis of Major Depression with psychotic features (296.xx)
  • Decisional capacity to provide informed consent
  • At least two outpatient visits within last six months
  • At least monthly face-to-face contact for one hour or more with a patient-identified family member or caregiver
  • Assessment by the treating therapist or psychiatrist that the patient is clinically stable enough to participate in the program.
  • Age 18-80 years
  • Decisional capacity to provide informed consent
  • Permission from veteran to be contacted

You may not qualify if:

  • Patients whose families have attended the FPE group within the last six months
  • Patients whose families have had at least monthly clinician contact in the last six months
  • Patients who are currently homeless
  • Patients who participated in the FMPO pilot.
  • Individuals who participated in the FMPO pilot.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (3)

  • Glynn SM, Dixon LB, Cohen A, Murray-Swank A. The Family Member Provider Outreach program. Psychiatr Serv. 2008 Aug;59(8):934. doi: 10.1176/ps.2008.59.8.934. No abstract available.

    PMID: 18678695RESULT

  • Cohen AN, Drapalski AL, Glynn SM, Medoff D, Fang LJ, Dixon LB. Preferences for family involvement in care among consumers with serious mental illness. Psychiatr Serv. 2013 Mar 1;64(3):257-63. doi: 10.1176/appi.ps.201200176.

    PMID: 23242515RESULT

  • Dixon LB, Glynn SM, Cohen AN, Drapalski AL, Medoff D, Fang LJ, Potts W, Gioia D. Outcomes of a brief program, REORDER, to promote consumer recovery and family involvement in care. Psychiatr Serv. 2014 Jan 1;65(1):116-20. doi: 10.1176/appi.ps.201300074.

    PMID: 24177229RESULT

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersDepressive Disorder, MajorMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersDepressive DisorderMood Disorders

Results Point of Contact

Title
Amy Drapalski, Ph.D.
Organization
VA VISN 5 Mental Illness Research, Education and Clinical Center
amy.drapalski@va.gov
410-637-1855

Study Officials

  • Lisa B Dixon, MD MPH

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 27, 2007

Study Start

September 1, 2007

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

April 24, 2015

Results First Posted

October 20, 2014

Record last verified: 2014-08

Locations

US(2)