Illness Management and Recovery Treatment Integrity Scale Validation and Leadership Intervention Development

Severe Mental Illness Clinical Trial

— IT IS VALID  

Official title:

Illness Management and Recovery Treatment Integrity Scale Validation and Leadership Intervention Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431299
• Other study ID #: 1R21MH096835-01
• Status: Completed
• Phase: N/A
• First received: April 23, 2015
• Last updated: November 19, 2015
• Start date: September 2012

Study information

• Verified date: November 2015
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: Indiana University Institution Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mental Disorders
• Severe Mental Illness

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Working Alliance Inventory Short Form	This is a consumer rated scale indicated working alliance between consumer and clinician. The scale has 12 items, rated on a 7 point Likert style scale (ranging from 1-7). The total score provided a mean score of all 12 items. Better working alliance is indicated by a higher score.	3-Months	No
Secondary	Multidimensional Scale of Perceived Social Support	This scale is a consumer rated assessment of perceived social support systems. There are 12 items each rated on a 7 point Likert scale (ranging from 1-7). A mean score is calculated from all 12 items. Higher scores represent better outcomes (i.e. higher levels of perceived social support).	3-Months	No
Secondary	Adult State Hope Scale	This is a consumer rated measure that assesses the level of goal related hope a consumer possesses. This version is a 6 item measure, with each item rated on a 4 point scale (range 1-4, with 1 being "Definitely False" and 4 being "Definitely True"). A summary score is calculated by summing all 6 items. Higher scores represent better outcomes (i.e. higher goal related hope). These summary scores were then averages to calculate a mean score for our sample.	3-Months	No
Secondary	Brief COPE Adaptive Subscale	This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Adaptive coping is calculated by averaging the responses from 8 out of the 14 subscales. Higher scores indicate better outcomes (i.e. higher use of adaptive coping strategies).	3-Months	No
Secondary	Medication Adherence Rating Scale	This is a consumer rated scale assessing medication adherence. This is a 10 item scale with each question rated as "yes" or "no". A yes is assigned a value of 1. The scale ranges from 0 (no "yes" responses) to 10 (all "yes" responses endorsed). The total number of "yes" responses is totaled to create a summary score. The mean score is calculated based on averaging the summary scores for the entire consumer sample. Higher scores mean better outcomes for medication adherence.	3-Months	No
Secondary	UNCOPE Measure	This meThis measure is a consumer rated substance abuse screener consisting of 6 "yes" or "no" questions. A response of "yes" is assigned a value of 1. The total number of "yes" responses are summed and a score of greater than 4 indicates likelihood of substance abuse. Higher scores mean worse outcomes for this scale (i.e. the higher the score, the greater the likelihood of substance abuse issues).	3-Months	No
Secondary	Brief COPE Maladaptive Subscale	This is a consumer rated assessment of adaptive coping skills. This is derived from the 28 item, full scale. The scale uses a 1-4 Likert scale, indicating the frequency of using different coping strategies. There are 14 subscales, each calculated by summing 2 items. The range on each subscale is 2 - 8. The 14 subscales are further combined into 2 larger scales - maladaptive and adaptive coping. Maladaptive coping is calculated by averaging the responses from 6 out of the 14 subscales. Higher scores indicate worse outcomes (i.e. higher use of maladaptive coping strategies).	3-Months	No