NCT00078741

Brief Summary

This study will develop a cognitive behavioral therapy (CBT) program to treat symptoms of post-traumatic stress disorder (PTSD) in people with severe mental illnesses who are treated within community mental health systems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2004

Typical duration for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

August 10, 2015

Status Verified

December 1, 2007

Enrollment Period

2.2 years

First QC Date

March 5, 2004

Last Update Submit

August 7, 2015

Conditions

Stress Disorders, Post-TraumaticSchizophrenia

Keywords

Psychotic Disorders

Interventions

Cognitive Behavioral Therapy (CBT)BEHAVIORAL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of PTSD and schizophrenia or schizoaffective disorder
  • Active involvement in case management

You may not qualify if:

  • Suicide risk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

South Carolina Department of Mental Health

Columbia, South Carolina, 29202, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticSchizophreniaPsychotic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Christopher Frueh

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2004

First Posted

March 8, 2004

Study Start

January 1, 2004

Primary Completion

March 1, 2006

Study Completion

September 1, 2007

Last Updated

August 10, 2015

Record last verified: 2007-12

Locations

US(2)