NCT00980252

Brief Summary

This is a randomized pilot study of an intervention based on principles of Cognitive Behavioral Therapy (CBT). This intervention is the Health Dialogue Intervention (HDI) and will be compared to a traditional medical model of psychoeducation known as Team Solutions (TS) for first-episode schizophrenia patients. Outcomes include the acceptance of HDI and TS, compare adherence attitudes at the end of the treatment intervention, and to compare the time until the first episode of nonadherence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable schizophrenia

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

First Submitted

Initial submission to the registry

September 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

3.1 years

First QC Date

September 18, 2009

Last Update Submit

June 13, 2014

Conditions

SchizophreniaPsychotic Disorders

Keywords

SchizophreniaCognitive Behavioral TherapyComplianceMedication AdherencePsychotic DisordersMental DisordersOutcomesPsychoeducationAdherence AttitudesInterventionNonadherenceSchizophrenia and Disorders with Psychotic Features

Outcome Measures

Primary Outcomes (1)

  • 1. Acceptance of therapeutic intervention as measured by number of sessions attended. 2. Difference in adherence behavior as measured by duration of antipsychotic treatment during follow up (ASV). 3. Differences in adherence attitudes (ROMI).

    Completion of Study

Secondary Outcomes (1)

  • 1. Compare the course of symptoms and relapse of patients in HDI to those in the TS.

    Completion of Study

Study Arms (1)

CBT

EXPERIMENTAL

UK-based intervention

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Brief intervention of Cognitive Behavioral Therapy sessions compared to Team Solutions

CBT

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Between 16-45 years of age
  • A provisional clinical diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder in last 6 months
  • Discharge from inpatient unit for treatment of psychotic symptoms must have occurred in the last 6 months, or, if never hospitalized, initial treatment started in the last 6 months
  • Able to fully participate in the informed consent process
  • The patient is judged to be an appropriate candidate for ongoing outpatient follow-up at the First-episode Treatment Program at the Psychotic Disorders Program at UIC
  • Unable to understand informed consent process
  • A history of nonresponse to prior antipsychotic trials such that long-term inpatient treatment or clozapine will be recommended
  • Prior treatment with clozapine
  • Discharge from inpatient treatment for psychotic symptoms, initial treatment, or provisional diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform occurred more than 6 months from enrollment into the evaluation phase
  • Pregnancy or stated goal to become pregnant
  • Will not be living close enough to the medical center to return for follow-up visits or assessments
  • History of geographic instability such that it is judged unlikely that patient will reside in the area
  • Currently under arrest for a felony, or an arrest is deemed likely in the near future
  • Currently receiving medication over objection by court order
  • Currently receiving treatment in another research protocol
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersPatient ComplianceMedication AdherenceMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Peter J. Weiden, M.D.

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 21, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

US(1)