Severe Mental IllnessACT+IMRNCT03075800
Integration of Illness Management and Recovery Within ACT
A study testing Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR) in people with Severe Mental Illness and Schizophrenia, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 69 years
- Conditions the study is for
- Severe Mental Illness, Schizophrenia, Bipolar Disorder
- What is being tested?
- Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- 7 Jun 2011to 31 Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
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.
Read the 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.
- Conditions
- Severe Mental Illness, Schizophrenia, Bipolar Disorder
- Being tested
- Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)
- Keywords
- Assertive Community Treatment (ACT) Only, Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)Behavioural
Also called ACT+IMR
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, 6, and 12 months
Secondary outcomes (5)
Brief Psychiatric Rating Scale (BPRS)
Mental Health Symptoms
Measured: 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)
Psychosocial Functioning
Measured: baseline, 6, and 12 months
Recovery Assessment Scale (RAS)
Recovery
Measured: baseline, 6, and 12 months
Community Integration Measure (CIM)
Community Integration
Measured: baseline, 6, and 12 months
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.
Measured: baseline, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start7 Jun 2011
- Primary completion31 Mar 2015
- Study completion31 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Monroe-DeVita, University of Washington
- Investigators
- Maria Monroe-DeVita, PhD, Principal investigator, Co-PI, University of Washington, Seattle, WAGary Morse, PhD, Principal investigator, Co-PI, Places for People, St. Louis, MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075800
- Sponsor's protocol ID
- 40487-C
- Acronym
- ACT+IMR
- Status last verified
- Mar 2017
- First submitted
- 3 Mar 2017
- Last updated
- 9 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Illness Management and Recovery Within ACT
- ClinicalTrials.gov ID
- NCT03075800
- Acronym / sponsor ID
- ACT+IMR / 40487-C
- Conditions
- Severe Mental Illness, Schizophrenia, Bipolar Disorder
- Keywords
- Assertive Community Treatment (ACT) Only, Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 7 Jun 2011 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Mar 2015 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)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. |
Who may qualify
- Ages
- 23 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)Also: ACT+IMRThe 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. | Behavioural | Assertive Community Treatment+Illness Management and Recovery |
Primary outcome
Illness Self-Management - The Clinician and Client Versions of the IMR Scale
Time frame: baseline, 6, and 12 months
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).
5 secondary outcomes
Brief Psychiatric Rating Scale (BPRS)
Time frame: 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)
Time frame: baseline, 6, and 12 months
Recovery Assessment Scale (RAS)
Time frame: baseline, 6, and 12 months
Community Integration Measure (CIM)
Time frame: baseline, 6, and 12 months
Emergency mental health services
Time frame: baseline, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Monroe-DeVita, PhD principal investigator
Co-PI, University of Washington, Seattle, WA
Gary Morse, PhD principal investigator
Co-PI, Places for People, St. Louis, MO
Questions about this trial
What is this clinical trial studying?
A study testing Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR) in people with Severe Mental Illness and Schizophrenia, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illness Self-Management - The Clinician and Client Versions of the IMR Scale (time frame: baseline, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.