Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Illness Management and Recovery for Veterans With Severe Mental Illness

This study has been completed.
Sponsor:
Collaborators:
Indiana University
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00515671
First received: August 10, 2007
Last updated: April 6, 2015
Last verified: September 2014
Results First Received: October 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizo-affective Disorder
Interventions: Behavioral: Illness Management and Recovery
Behavioral: Problem Solving

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm 1

Receives IMR groups once a week for 9 months in addition to care as usual.

Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness

Arm 2

Receives support groups once a week for 9 months in addition to care as usual.

Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness


Participant Flow:   Overall Study
    Arm 1   Arm 2
STARTED   60   58 
COMPLETED   43   41 
NOT COMPLETED   17   17 
Lost to Follow-up                13                10 
Withdrawal by Subject                3                5 
incarcerated                1                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm 1

Receives IMR groups once a week for 9 months in addition to care as usual.

Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness

Arm 2

Receives support groups once a week for 9 months in addition to care as usual.

Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness

Total Total of all reporting groups

Baseline Measures
   Arm 1   Arm 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 60   58   118 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.7  (9.3)   47.6  (8.5)   47.7  (8.9) 
Gender 
[Units: Participants]
     
Female   46   48   94 
Male   14   10   24 
Race/Ethnicity, Customized 
[Units: Participants]
     
white   22   18   40 
African American   32   40   72 
More than one   6   0   6 
Region of Enrollment 
[Units: Participants]
     
United States   60   58   118 


  Outcome Measures
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1.  Primary:   Illness Management Ratings   [ Time Frame: Baseline, 9 months, 18 months ]

2.  Secondary:   Psychiatric Symptoms (PANSS Total)   [ Time Frame: Baseline, 9 months, 18 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Low attendance in both groups, may not have had enough "exposure" Study embedded in a treatment-rich environment, cannot sort out other impacts on outcomes.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michelle Salyers
Organization: IUPUI
phone: 317-274-2904
e-mail: mpsalyer@iupui.edu


Publications of Results:


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00515671     History of Changes
Other Study ID Numbers: IAC 05-254
Study First Received: August 10, 2007
Results First Received: October 3, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government