Illness Management and Recovery Treatment Integrity Scale Validation and Leadership Intervention Development
IT IS VALID
1 other identifier
observational
299
0 countries
N/A
Brief Summary
Illness Management and Recovery (IMR) is an evidenced-based approach to teaching consumers with severe mental illness how to set and achieve personal recovery goals and acquire the knowledge and skills to independently manage their illnesses. Longitudinal, multi-site, and randomized controlled trials have shown IMR to be effective in increasing illness self-management and coping; some evidence also points to reduced hospitalization rates. Fidelity, or adherence to a specific treatment model, is equally important to both clinical research and to the practical dissemination of evidence-based practices to the field. To this end, the research team has developed an IMR clinician-level fidelity assessment, the IMR Treatment Integrity Scale (IT-IS). However, the validity of the preliminary IT-IS has not been rigorously evaluated. Additionally, it is crucial to develop strategies to utilize the IT IS to increase adherence to the IMR model and ultimately increase consumer outcomes. The purpose of this study is to assess the construct validity of the IT-IS by testing the relationship between IT-IS elements and mechanisms of change and proximal outcomes. The investigators will collect a sample of IMR session recordings and pre-post data from IMR participants from recruitment sites in Indiana, New Jersey and several other states. The investigators will test hypothesized relationships between specific program elements and theoretically proposed mechanisms of change. The investigators will also assess organizational and clinician factors affecting IMR competence by including a survey for the staff members who are located as sites where the investigators have clinicians participating in providing IMR.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
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
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 23, 2015
CompletedFirst Posted
Study publicly available on registry
May 1, 2015
CompletedResults Posted
Study results publicly available
December 23, 2015
CompletedDecember 23, 2015
November 1, 2015
1.8 years
April 23, 2015
August 31, 2015
November 19, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Illness Management and Recovery Scale
Post-intervention scores were assessed. This measure is designed to assess consumer-rated illness self management skills. This scale is based on a 15 items, each rated on a 5 point Likert scale, ranging from 1 to 5. Higher numbers of this scale represent better outcomes. A mean score of all 15 items is provided as the primary outcome score for this scale.
3-Months
Illness Management and Recovery Treatment Integrity Scale
Clinician competency rating scale was used to assess clinician competence in providing IMR. This data was used to test the theory that IMR competency would impact consumers' ability to engage in illness self management practices as rated by the Illness Management and Recovery Scale. This scale is rated by trained observers, and the scale contains 16 items, rated on a 1 - 5 point scale. A 5 indicates higher competency and fidelity to the IMR treatment model. A mean score is calculated across all 16 items. Higher scores indicate higher clinician competence in providing IMR.
3-Months
Secondary Outcomes (7)
Working Alliance Inventory Short Form
3-Months
Multidimensional Scale of Perceived Social Support
3-Months
Adult State Hope Scale
3-Months
Brief COPE Adaptive Subscale
3-Months
Medication Adherence Rating Scale
3-Months
- +2 more secondary outcomes
Eligibility Criteria
Consumers with mental illness, who are participating in the Illness Management and Recovery intervention in New Jersey and Indiana. This includes consumers from state hospitals, rehabilitation centers and community mental health centers. Additionally, the clinicians who are leading the intervention are considered to be participants of the study as well.
You may qualify if:
- Clinicians:
- years or older
- Providing IMR individually or in group format at a participating agency
- Willing and able to provide consent
- Willing to complete study measures
- Willing to be audio recorded
- Consumers:
- years or older
- Willing and able to provide consent
- Able to complete a brief cognitive screener
- Willing to complete study measures
- Receiving IMR intervention at a participating agency
- Willing to be audio recorded
You may not qualify if:
- Individuals younger than 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Limitations and Caveats
Unable to randomly assign a level of competency in providing IMR. Geographically limited to three states within the United States. Relatively brief observation period (3-months).
Results Point of Contact
- Title
- Dr. Alan B. McGuire
- Organization
- Indiana University Purdue University Indianapolis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
April 23, 2015
First Posted
May 1, 2015
Study Start
September 1, 2012
Primary Completion
July 1, 2014
Last Updated
December 23, 2015
Results First Posted
December 23, 2015
Record last verified: 2015-11