Clinical trial NCT02431299: Illness Management and Recovery Treatment Integrity Scale Validation and Leadership Intervention Development
Official title: Illness Management and Recovery Treatment Integrity Scale Validation and Leadership Intervention Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Mental Illness
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2015-05-01
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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

Primary outcomes:
measure: Illness Management and Recovery Scale
timeFrame: 3-Months
measure: Illness Management and Recovery Treatment Integrity Scale
timeFrame: 3-Months
Secondary outcomes:
measure: Working Alliance Inventory Short Form
timeFrame: 3-Months
measure: Multidimensional Scale of Perceived Social Support
timeFrame: 3-Months
measure: Adult State Hope Scale
timeFrame: 3-Months
measure: Brief COPE Adaptive Subscale
timeFrame: 3-Months
measure: Medication Adherence Rating Scale
timeFrame: 3-Months
measure: UNCOPE Measure
timeFrame: 3-Months
measure: Brief COPE Maladaptive Subscale
timeFrame: 3-Months
Other outcomes:
Locations:
Study officials:
References: