NCT00137267

Brief Summary

Surveys suggest that up to 80% of veterans with a persistent mental illness have a co-occurring substance use disorder. Substance abuse among this population is problematic and often results in poor engagement in treatment and thus, frequent hospitalizations and an unstable illness course. Regarding treatment engagement, data from a VA New Jersey facility indicated that 50% of those veterans discharged from the acute psychiatric hospital unit to outpatient care did not attend their initial screening appointment and another 30% dropped out within six weeks. To assist with the transition from inpatient to outpatient care, we previously developed an eight-week augmentation intervention entitled, Time-Limited Case Management (TLC). TLC integrates evidence-based interventions of 1) Dual Recovery Therapy; 2) Critical Time Intervention Case Management along with 3) Peer Support with the goal of assisting individuals with the transition from inpatient to outpatient care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2005

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

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

April 29, 2015

Completed
Last Updated

May 15, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

August 25, 2005

Results QC Date

August 25, 2014

Last Update Submit

April 29, 2015

Conditions

Keywords

Schizophrenia / disorders w psychotic featuresSubstance-related disordersCommunity Mental Health ServicesCase ManagementHealth Education

Outcome Measures

Primary Outcomes (1)

  • Treatment Engagement

    Number of inpatient and outpatient treatment sessions attended during the 8-week treatment period

    8 weeks

Secondary Outcomes (1)

  • Number of Days Engaged

    8 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.

Behavioral: Time limited case management

Arm 2

ACTIVE COMPARATOR

This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.

Behavioral: Health Education

Interventions

This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.

Also known as: TLC
Arm 1

This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.

Also known as: TAU+A
Arm 2

Eligibility Criteria

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

You may qualify if:

  • Male and female patients over 18 years old.
  • Patients who have a substance abuse disorder and a diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder.
  • Patients seeking outpatient treatment for the above disorders from the VA.
  • Physically mobile
  • Agree to take public transportation if they do not have other private sources.

You may not qualify if:

  • Patients who only have either a mental health problem, or a substance abuse problem, but not both.
  • Patients who do not have a residence where they can stay upon discharge from the hospital.
  • Patients who are not sufficiently medically or psychiatrically stable to participate in residential or outpatient treatment. Those patients could be re-evaluated for the study once stabilized.
  • Patients exclusively engaged in methadone maintenance programs.
  • Patients who represent a serious suicide risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford

Bedford, Massachusetts, 01730, United States

Location

VA New Jersey Health Care System, East Orange

East Orange, New Jersey, 07018, United States

Location

Related Publications (4)

  • Ziedonis DM, Smelson D, Rosenthal RN, Batki SL, Green AI, Henry RJ, Montoya I, Parks J, Weiss RD. Improving the care of individuals with schizophrenia and substance use disorders: consensus recommendations. J Psychiatr Pract. 2005 Sep;11(5):315-39. doi: 10.1097/00131746-200509000-00005.

  • Smelson DA, Dixon L, Craig T, Remolina S, Batki SL, Niv N, Owen R. Pharmacological treatment of schizophrenia and co-occurring substance use disorders. CNS Drugs. 2008;22(11):903-16. doi: 10.2165/00023210-200822110-00002.

  • Sussner B, Kline A, Smelson DA, Losonczy M, Salvatore S. The role of psychosocial characteristics in irregular discharge form residentioal services for homeless veterans. Psychological Services. 2008 May 1; 5(4):341-350.

    RESULT
  • Banerjea R, Pogach LM, Smelson D, Sambamoorthi U. Mental illness and substance use disorders among women veterans with diabetes. Womens Health Issues. 2009 Nov-Dec;19(6):446-56. doi: 10.1016/j.whi.2009.07.007.

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersSubstance-Related DisordersBipolar DisorderHealth Education

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersChemically-Induced DisordersBipolar and Related DisordersMood DisordersAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr. David Smelson
Organization
Bedford VA Medical Center

Study Officials

  • David A. Smelson, PsyD

    Edith Nourse Rogers Memorial Veterans Hospital, Bedford

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

June 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

May 15, 2015

Results First Posted

April 29, 2015

Record last verified: 2015-04

Locations