NCT02431299

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

100
On Track

Trial Health Score

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

Enrollment
299

participants targeted

Target at P75+ for all trials

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

Study Start

First participant enrolled

September 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

December 23, 2015

Completed
Last Updated

December 23, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

April 23, 2015

Results QC Date

August 31, 2015

Last Update Submit

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

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

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

Mental Disorders

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