N/A
N=299
Illness Management and Recovery Treatment Integrity Scale Validation and Leadership Intervention Development
Severe Mental Illness
Bottom Line
View on ClinicalTrials.gov: NCT02431299 ↗Enrolled (actual)
299
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Illness Management and Recovery Scale — 3.72 units on a scale — p=<0.01
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Illness Management and Recovery Scale |
3.72 | <0.01 sig |
| PRIMARY Illness Management and Recovery Treatment Integrity Scale |
2.73 | <0.05 sig |
| SECONDARY Working Alliance Inventory Short Form |
5.58 | — |
| SECONDARY Multidimensional Scale of Perceived Social Support |
5.18 | — |
| SECONDARY Adult State Hope Scale |
19.13 | — |
| SECONDARY Brief COPE Adaptive Subscale |
5.73 | — |
| SECONDARY Medication Adherence Rating Scale |
2.45 | — |
| SECONDARY UNCOPE Measure |
.30 | — |
| SECONDARY Brief COPE Maladaptive Subscale |
4.47 | — |
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.
Eligibility Criteria
Inclusion Criteria
Clinicians:
- 18 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:
- 18 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
Exclusion Criteria
- Individuals younger than 18 years old
Data sourced from ClinicalTrials.gov (NCT02431299). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.