NCT03075800

Brief Summary

Integrating Illness Management and Recovery (IMR) into Assertive Community Treatment (ACT) has great promise for improving the symptomatic, functional, and recovery outcomes for people with Serious Mental Illness (SMI), especially those individuals who have the greatest needs. In addition to these positive consumer outcomes, system benefits may also accrue due to more rapid graduation of consumers from ACT (with IMR) programs to less intensive levels of care. However, before these benefits can be realized, research and development are needed to design and pilot test a treatment manual that is feasible and acceptable to consumers and staff for integrating IMR and ACT.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

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

June 7, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

3.8 years

First QC Date

March 3, 2017

Last Update Submit

March 8, 2017

Conditions

Keywords

Assertive Community Treatment (ACT) OnlyAssertive Community Treatment (ACT) + Illness Management and Recovery (IMR)

Outcome Measures

Primary Outcomes (1)

  • Illness Self-Management - The Clinician and Client Versions of the IMR Scale

    evaluate illness self-management across 15 items rated on 5-point behaviorally anchored scales, with higher scores indicating better illness management. Overall scores are averages of the 15 items (ranging from 15 to 75).

    baseline, 6, and 12 months

Secondary Outcomes (5)

  • Brief Psychiatric Rating Scale (BPRS)

    baseline, 6, and 12 months

  • Daily Living Activities Scale (DLA-20), the Global Assessment of Functioning (GAF), and the Quality of Life Scale-Abbreviated (QLSA)

    baseline, 6, and 12 months

  • Recovery Assessment Scale (RAS)

    baseline, 6, and 12 months

  • Community Integration Measure (CIM)

    baseline, 6, and 12 months

  • Emergency mental health services

    baseline, 6, and 12 months

Study Arms (2)

Assertive Community Treatment (ACT) - Only

NO INTERVENTION

ACT is a multidisciplinary, team-based approach to providing a range of treatment, rehabilitation, and support services to high-need, high-risk people with severe mental illness who tend not to use clinic-based services; most services are provided on an outreach basis (e.g., in the person's home) and services are available 24 /7(27).

Assertive Community Treatment+Illness Management and Recovery

EXPERIMENTAL

IMR follows a manualized curriculum to help clients pursue personal recovery goals and to teach them information, strategies, and skills over 11 modules (e.g., using medications, coping with stress) to manage their psychiatric illness. IMR can be provided in individual or group formats. The integrated ACT+IMR model was developed and manualized prior to the start of this evaluation (27). The model incorporates the following key features: a) ACT staff provide IMR in office-based group and/or individual sessions in office or community settings; b) regular community follow-up by ACT staff to assist clients with practicing IMR skills and achieving their goals; c) regular communication within ACT team (e.g., during daily meetings) on IMR client goals and progress; and d) supervision and consultation on IMR within ACT.

Behavioral: Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)

Interventions

The integrated ACT+IMR model was developed and manualized prior to the start of this evaluation (27). The model incorporates the following key features: a) ACT staff provide IMR in office-based group and/or individual sessions in office or community settings; b) regular community follow-up by ACT staff to assist clients with practicing IMR skills and achieving their goals; c) regular communication within ACT team (e.g., during daily meetings) on IMR client goals and progress; and d) supervision and consultation on IMR within ACT.

Also known as: ACT+IMR
Assertive Community Treatment+Illness Management and Recovery

Eligibility Criteria

Age23 Years - 69 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Eight ACT teams in two states were recruited, with four teams in each state. Selection criteria included: 1. no prior IMR training; and 2. good fidelity to ACT, defined as a score \> 3.5 (out of 5.0) on the Tool for Measurement of Assertive Community Treatment during state-sponsored fidelity assessments in 2012.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Mental DisordersSchizophreniaBipolar Disorder

Interventions

Community Mental Health ServicesSalvage Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesTherapeutics

Study Officials

  • Maria Monroe-DeVita, PhD

    Co-PI, University of Washington, Seattle, WA

    PRINCIPAL INVESTIGATOR
  • Gary Morse, PhD

    Co-PI, Places for People, St. Louis, MO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A pilot, cluster randomized controlled trial was conducted in which ACT teams were randomized to provide either IMR within ACT (ACT+IMR) or standard ACT treatment (ACT-only). The impact of ACT+IMR vs. ACT-only on illness management and recovery outcomes was based on assessments conducted on a subset of randomly selected clients from each team, conducted at baseline, six months, and one year. Randomization to ACT+IMR or ACT-only was stratified by state and by team size, resulting in one large team and one small team assigned to each condition in each state.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 3, 2017

First Posted

March 9, 2017

Study Start

June 7, 2011

Primary Completion

March 31, 2015

Study Completion

March 31, 2015

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share