NCT00307216

Brief Summary

This study will determine the effectiveness of the Graduated Recovery Intervention Program, a manual-based individual therapy program, in enhancing the clinical benefit of routine treatment for individuals recovering from their first episodes of psychosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

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

March 23, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2006

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 29, 2013

Status Verified

March 1, 2013

Enrollment Period

2.7 years

First QC Date

March 23, 2006

Last Update Submit

March 28, 2013

Conditions

Psychotic DisordersSchizophrenia

Keywords

First Episode PsychosisEarly PsychosisPsychosocial Intervention

Outcome Measures

Primary Outcomes (4)

  • Role Functioning Scale

    Measured at baseline, post-test, and Month 3 follow-up

  • Heinrichs-Carpenter Quality of Life Scale (QLS)

    Measured at baseline, post-test, and Month 3 follow-up

  • Multidimensional Scale of Perceived Social Support (MSPSS)

    Measured at baseline, post-test, and Month 3 follow-up

  • Global Functioning Scale

    Measured at baseline, post-test, and Month 3 follow-up

Secondary Outcomes (12)

  • Brief Evaluation of Medication Influences and Beliefs

    Measured at baseline, post-test, and Month 3 follow-up

  • Positive and Negative Syndrome Scale (PANSS)

    Measured at baseline, post-test, and Month 3 follow-up

  • Calgary Depression Scale for Schizophrenia (CDSS)

    Measured at baseline, post-test, and Month 3 follow-up

  • Brief Trauma Questionnaire (BTQ)

    Measured at baseline, post-test, and Month 3 follow-up

  • PTSD Checklist (PCL)

    Measured at baseline, post-test, and Month 3 follow-up

  • +7 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Participants will receive Graduated Recovery Intervention Program plus treatment as usual

Behavioral: Graduated Recovery Intervention Program (GRIP)Behavioral: Treatment as usual (TAU)

2

ACTIVE COMPARATOR

Participants will receive treatment as usual

Behavioral: Treatment as usual (TAU)

Interventions

Graduated Recovery Intervention Program (GRIP)BEHAVIORAL

GRIP is a manual-based comprehensive psychosocial intervention for people recovering from an initial episode of nonaffective psychosis. The purpose of GRIP is to improve occupational functioning after first-episode psychosis and promote goal pursuit and effective illness self-management. Participants assigned to receive TAU plus GRIP will attend therapy sessions weekly for up to 36 weeks, in addition to routine appointments. GRIP includes four phases, each of which focuses on one of the following topics: engagement and wellness management, substance use, persistent symptoms, and functional recovery.

1
Treatment as usual (TAU)BEHAVIORAL

Participants receiving TAU will meet with their case-manager and health care providers on an as-needed basis.

12

Eligibility Criteria

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

You may qualify if:

  • Meets DSM-IV criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder
  • Has been in treatment for psychosis for less than 3 years
  • Clinically stable (based on clinician judgement)
  • IQ score greater than 70
  • Currently receiving keyworker services at UNC Hospital's OASIS program

You may not qualify if:

  • Organic brain disorder
  • Substance-induced psychotic disorder
  • Mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Hospitals OASIS Program for Early Psychosis

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophrenia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • David L. Penn, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Diana O. Perkins, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

March 23, 2006

First Posted

March 27, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 29, 2013

Record last verified: 2013-03

Locations

US(1)