NCT00515671

Brief Summary

The President's New Freedom Commission on Mental Health has called for a transformation of the mental health system to partner with consumers of those services in delivering effective interventions focused on recovery, and the Department of Veterans Affairs (VA) has developed a Mental Health Strategic Plan to address these recommendations. One promising approach is to implement Illness Management and Recovery (IMR), a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness. IMR was developed from a review of effective approaches for illness self-management training in persons with severe mental illness. The 9-month curriculum is taught using motivational, educational, and cognitive-behavioral techniques, and incorporates five evidence-based practices: education about mental illness, strategies for increasing medication adherence, skills training to enhance social support, relapse prevention planning, and coping skills training. The program was developed for widespread dissemination and includes a manual, worksheets, an introductory video, a clinical training video, a fidelity scale, and informational brochures for consumers, family members, clinicians, and administrators.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Jan 2008

Longer than P75 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

August 10, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 10, 2014

Completed
Last Updated

December 15, 2021

Status Verified

December 1, 2021

Enrollment Period

4.3 years

First QC Date

August 10, 2007

Results QC Date

October 3, 2014

Last Update Submit

December 7, 2021

Conditions

Keywords

self-managementrecoverysevere mental illness

Outcome Measures

Primary Outcomes (1)

  • Illness Management Ratings

    Illness self-management was assessed with the consumer-rated Illness Management and Recovery Scale. Items are rated on a 5-point behaviorally anchored scale; the mean across all 15 items forms an overall score of illness management (ranging from 1 to 5), with higher scores indicating better self-management.

    Baseline, 9 months, 18 months

Secondary Outcomes (1)

  • Psychiatric Symptoms (PANSS Total)

    Baseline, 9 months, 18 months

Study Arms (2)

Arm 1_IMR

EXPERIMENTAL

Illness Management and Recovery was offered in small groups (less than 8), co-facilitated by either an experienced masters level clinician or a doctoral level psychologist and by a doctoral student in clinical psychology. Facilitators used the IMR curriculum, incorporating psychoeducation, cognitive-behavioral approaches, relapse prevention, social skills training, and coping skills training. Facilitators worked with groups to set personal recovery goals and address progress towards those goals throughout the intervention. Home assignments helped participants apply newly learned skills and/or make progress on goals. Groups were open to rolling admission across the study period

Behavioral: Illness Management and Recovery

Arm 2_PS

PLACEBO COMPARATOR

Problem Solving was the active control condition (also offered in groups weekly for 9 months). Participants were encouraged to discuss current concerns and receive group support; we did not use structured problem solving tasks. These groups were led by the same facilitators described above, who helped establish group expectations (attendance, confidentiality), encouraged participation, and provided process-oriented observations; there was no formal curriculum, goal setting, or homework assignments.

Behavioral: Problem Solving

Interventions

a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness

Also known as: IMR
Arm 1_IMR
Problem SolvingBEHAVIORAL

Weekly problem-solving support group

Also known as: PS
Arm 2_PS

Eligibility Criteria

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

You may qualify if:

  • Currently receiving (or newly admitted to) mental health services from any mental health treatment programs at the Roudebush VAMC or Midtown Community Mental Health Center (MCMHC) in Indianapolis, IN
  • Age 18 or older
  • SCID-confirmed diagnosis of schizophrenia or schizoaffective disorder
  • Stated interest in learning more about their illness
  • Willing and able to give informed consent

You may not qualify if:

  • Severe medical condition that would limit participation in an 18-month study (e.g., end stage renal disease, metastatic cancer, life expectancy less than 18 months; if participant is unsure, with permission will contact primary physician)
  • Evidence of dementia or severe cognitive dysfunction on cognitive screener

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (7)

  • Frankel RM, Salyers MP, Bonfils KA, Oles SK, Matthias MS. Agenda setting in psychiatric consultations: an exploratory study. Psychiatr Rehabil J. 2013 Sep;36(3):195-201. doi: 10.1037/prj0000004. Epub 2013 Jul 1.

  • McGuire AB, Bonfils KA, Kukla M, Myers L, Salyers MP. Measuring participation in an evidence-based practice: illness management and recovery group attendance. Psychiatry Res. 2013 Dec 30;210(3):684-9. doi: 10.1016/j.psychres.2013.08.008. Epub 2013 Sep 5.

  • Matthias MS, Salyers MP, Frankel RM. Re-thinking shared decision-making: context matters. Patient Educ Couns. 2013 May;91(2):176-9. doi: 10.1016/j.pec.2013.01.006. Epub 2013 Feb 11.

  • McGuire AB, Kukla M, Green A, Gilbride D, Mueser KT, Salyers MP. Illness management and recovery: a review of the literature. Psychiatr Serv. 2014 Feb 1;65(2):171-9. doi: 10.1176/appi.ps.201200274.

  • Salyers MP, McGuire AB, Kukla M, Fukui S, Lysaker PH, Mueser KT. A randomized controlled trial of illness management and recovery with an active control group. Psychiatr Serv. 2014 Aug 1;65(8):1005-11. doi: 10.1176/appi.ps.201300354.

  • McGuire AB, Stull LG, Mueser KT, Santos M, Mook A, Rose N, Tunze C, White LM, Salyers MP. Development and reliability of a measure of clinician competence in providing illness management and recovery. Psychiatr Serv. 2012 Aug;63(8):772-8. doi: 10.1176/appi.ps.201100144.

  • Tsai J, Salyers MP, McGuire AB. A cross-sectional study of recovery training and staff attitudes in four community mental health centers. Psychiatr Rehabil J. 2011 Winter;34(3):186-93. doi: 10.2975/34.3.2011.186.193.

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMental Disorders

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

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.

Results Point of Contact

Title
Michelle Salyers
Organization
IUPUI

Study Officials

  • Michelle P Salyers, MS PhD

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

August 10, 2007

First Posted

August 14, 2007

Study Start

January 1, 2008

Primary Completion

April 1, 2012

Study Completion

September 1, 2013

Last Updated

December 15, 2021

Results First Posted

October 10, 2014

Record last verified: 2021-12

Locations