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Integration of Illness Management and Recovery Within ACT (ACT+IMR)

Primary Purpose

Severe Mental Illness, Schizophrenia, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Mental Illness focused on measuring Assertive Community Treatment (ACT) Only, Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)

Eligibility Criteria

23 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Assertive Community Treatment (ACT) - Only

    Assertive Community Treatment+Illness Management and Recovery

    Arm Description

    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).

    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.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Brief Psychiatric Rating Scale (BPRS)
    Mental Health Symptoms
    Daily Living Activities Scale (DLA-20), the Global Assessment of Functioning (GAF), and the Quality of Life Scale-Abbreviated (QLSA)
    Psychosocial Functioning
    Recovery Assessment Scale (RAS)
    Recovery
    Community Integration Measure (CIM)
    Community Integration
    Emergency mental health services
    We examined two intensive services: emergency room and hospital admissions for mental health reasons. Research staff collected these data from ACT program staff for the 12-month study period.

    Full Information

    First Posted
    March 3, 2017
    Last Updated
    March 8, 2017
    Sponsor
    University of Washington
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03075800
    Brief Title
    Integration of Illness Management and Recovery Within ACT
    Acronym
    ACT+IMR
    Official Title
    Integration of Illness Management and Recovery Within ACT
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    June 7, 2011 (Actual)
    Primary Completion Date
    March 31, 2015 (Actual)
    Study Completion Date
    March 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Washington

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Despite significant advances in pharmacological treatments, many individuals with severe mental illnesses (SMI) such as schizophrenia and bipolar disorder continue to experience significant impairments in crucial life areas such as employment, housing, social functioning, and daily living skills. In addition, many of these individuals have significant levels of psychotic, mood, or negative symptoms, and are prone to frequent relapses and re-hospitalizations. Psychosocial treatments are needed to improve illness management and functioning beyond the limited effects of medication. However, relatively few psychosocial evidence-based practices (EBPs) exist for people with SMI and only a small percentage of people who could benefit from these treatments actually receive them. At the federal level, the implementation and dissemination of EBPs for people with SMI is a major policy priority and research objective. Assertive Community Treatment (ACT) Overview. ACT is one of five psychosocial treatments for people with SMI designated as an EBP by SAMHSA. Since its inception, ACT has grown from a single, experimental research treatment program to an essential element within the service continuum of most public mental health systems for people with SMI. ACT programs typically serve consumers with the most severe symptoms who have the greatest disability and support needs (e.g., high rates of homelessness and hospitalizations), and who are most difficult to engage and retain in standard outpatient programs. Research on ACT is extensive, with more than 25 RCTs. Literature reviews consistently conclude that ACT is more effective than standard community mental health services with demonstrated effectiveness in reducing psychiatric hospitalizations, and improving community tenure, retention in treatment, and high consumer and family satisfaction with services. However, ACT is less effective at improving symptom management, social functioning, and other functional outcomes, and needs to be adapted to better facilitate recovery. ACT is cost-effective compared to standard case management and has been widely disseminated with more than 300 ACT programs in at least 41 states. Illness Management and Recovery (IMR) Overview. The Illness Management and Recovery (IMR) program is well-suited for enhancing outcomes in those areas less effectively addressed by ACT: symptom management and community functioning. IMR is also one of five psychosocial EBPs identified by SAMHSA for adults with SMI. IMR programs have been widely implemented across the U.S. and other countries, and researchers have conducted a number of open clinical trials and quasi-experimental studies. Recently, three RCTs were conducted, supporting the effectiveness of group-based IMR implemented in outpatient mental health clinics and supported housing. These studies show significant positive outcomes with IMR, including symptom reduction, improved functioning, increased knowledge about mental illness, and progress toward personal recovery goals. Although these positive results support the effectiveness of IMR, several gaps and limitations are apparent in this growing area of practice and research. First, although IMR has been implemented clinically with very symptomatic consumers, such as inpatient and residential settings, controlled research on IMR has focused on outpatient settings, involving consumers who tend to be less symptomatic and higher functioning than those typically served on ACT teams. Second, providing IMR in outpatient clinics restricts the ability of clinicians to teach consumers skills in more natural community venues, which could improve the acquisition of new skills and related functional gains. Third, research on IMR has been mainly limited to the group modality, and hence, little is known about the effects of IMR provided in both individual and group formats. Integrating IMR with ACT. Several characteristics of ACT suggest it will be an excellent platform for integrating and implementing the IMR program. By design, ACT programs serve people with the greatest needs who tend to drop out of standard outpatient programs; thus, integrating IMR into ACT has the potential to improve illness self-management in those consumers who need it most. The individualized and assertive outreach nature of ACT services will also allow IMR to be delivered in both individual and group modalities, and the in vivo practice of ACT will empower consumers to learn and practice IMR skills in their natural settings. Finally, the ACT principle of working with families and natural supports will facilitate the involvement of those supports in helping consumers to better manage their SMI and to achieve their recovery goals. IMR also serves as an important potential service partner for ACT. ACT has been criticized by some as not being recovery-oriented. The integration of IMR may further enhance the growing recovery philosophy of ACT teams by providing a specific approach to promoting illness self-management and recovery that can be integrated into routine services. IMR can also improve the limited effectiveness of ACT teams at reducing symptoms and improving social and independent functioning. We also speculate (and plan to test in the subsequent, larger R01 research program) that providing IMR will accelerate the graduation of consumers from ACT, thereby increasing the number of slots available for new consumers in need of this scarce resource, further enhancing its cost-effectiveness. Thus, the integration of ACT and IMR has the potential to significantly benefit consumers with SMI, and increase the efficiency of the ACT model. Despite these potential benefits, there are substantial challenges to integrating IMR into ACT teams. IMR has been developed and used primarily in traditional treatment settings, not in mobile community treatment approaches (e.g. ACT). In practice, many ACT clinicians find that their time is devoted to responding to daily crises and acute case management needs; ACT staff members often have difficulty making time and learning how to implement more learning-based and recovery-oriented interventions. Most critically, there are no standardized guidelines for implementing IMR within ACT, making the integration of the two EBPs even more challenging. A few ACT teams, however, have foreseen the promise of integrating IMR into ACT. Using a nonequivalent group design, Garfinkle and Storch found that ACT consumers in IMR treatment showed a number of positive outcomes compared to ACT consumers without IMR services over 11 months, including lower hospitalization rates, improved retention of housing and competitive employment, and more work toward personal recovery goals. Salyers and colleagues conducted a small single group, pre-post pilot study to evaluate the feasibility of using peer specialists trained in IMR on ACT teams, and found that consumers who received IMR improved significantly on a measure of recovery, with a trend toward increased knowledge of mental illness, and consumer and staff satisfaction with IMR services. In a second study, Salyers and colleagues randomly assigned two of four ACT teams to IMR training and services (using only peer and mental health specialist staff for IMR service delivery). They reported that over the two-year period, ACT+IMR teams achieved moderate fidelity to IMR, but that rates of penetration were low, with only 25% of consumers having any exposure to IMR. However, secondary analyses found that ACT consumers who received IMR showed significant reductions in hospitalizations and incarcerations, and improvements in illness self-management. The lack of well developed guidelines for implementing IMR undoubtedly limited the effectiveness of the program in the Salyers' project. Fortunately, lessons learned from this study, as well as the SAMHSA EBP study on IMR and the present project team's practice and research experience with both ACT and IMR, suggest that with a number of adaptations IMR can be successfully integrated into ACT services. We plan to develop and implement the following promising strategies for integrating these two EBPs in this project: (1) develop an adapted manual, training resources, and fidelity scale specific to implementing IMR within ACT, (2) provide intensive initial and follow-up booster clinician training, (3) provide regularly scheduled clinical supervision of IMR within the ACT team, in addition to regularly scheduled outside consultation by IMR+ACT experts during project startup, (4) create an organizational culture that supports and champions the integration of IMR within ACT, (5) cross-train all ACT staff to support the consumer's participation in IMR, and (6) create several specific, strategic adaptations to ACT team operations and protocol to facilitate the practice of IMR within daily ACT service activities. We expect these implementation strategies to result in an integrated IMR+ACT program that yields positive outcomes both to consumers and mental health service delivery systems.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Mental Illness, Schizophrenia, Bipolar Disorder
    Keywords
    Assertive Community Treatment (ACT) Only, Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    101 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Assertive Community Treatment (ACT) - Only
    Arm Type
    No Intervention
    Arm Description
    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).
    Arm Title
    Assertive Community Treatment+Illness Management and Recovery
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)
    Other Intervention Name(s)
    ACT+IMR
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Illness Self-Management - The Clinician and Client Versions of the IMR Scale
    Description
    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).
    Time Frame
    baseline, 6, and 12 months
    Secondary Outcome Measure Information:
    Title
    Brief Psychiatric Rating Scale (BPRS)
    Description
    Mental Health Symptoms
    Time Frame
    baseline, 6, and 12 months
    Title
    Daily Living Activities Scale (DLA-20), the Global Assessment of Functioning (GAF), and the Quality of Life Scale-Abbreviated (QLSA)
    Description
    Psychosocial Functioning
    Time Frame
    baseline, 6, and 12 months
    Title
    Recovery Assessment Scale (RAS)
    Description
    Recovery
    Time Frame
    baseline, 6, and 12 months
    Title
    Community Integration Measure (CIM)
    Description
    Community Integration
    Time Frame
    baseline, 6, and 12 months
    Title
    Emergency mental health services
    Description
    We examined two intensive services: emergency room and hospital admissions for mental health reasons. Research staff collected these data from ACT program staff for the 12-month study period.
    Time Frame
    baseline, 6, and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    23 Years
    Maximum Age & Unit of Time
    69 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Eight ACT teams in two states were recruited, with four teams in each state. Selection criteria included: no prior IMR training; and 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria Monroe-DeVita, PhD
    Organizational Affiliation
    Co-PI, University of Washington, Seattle, WA
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Gary Morse, PhD
    Organizational Affiliation
    Co-PI, Places for People, St. Louis, MO
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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