Mental DisordersNCT05206188
Mastering the World of Work (MWW): RCT
A study testing Mastering the World of Work (MWW) in people with Mental Disorders and Employment, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
The purpose of this study is to conduct a randomized clinical trial for an innovative intervention entitled "Mastering the World of Work" (MWW). MWW aims to improve the employment outcomes of individuals with psychiatric disabilities who experience metacognitive deficits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders, Employment, Metacognition
- What is being tested?
- Mastering the World of Work (MWW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2022to 16 Sep 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are 18 or older
- have a DSM-IV diagnosis of serious mental illness, including dual diagnosis
- are currently receiving supported employment services (Individual Placement and Support) at the Mental Health Center of Greater Manchester, in Manchester, NH.
- are not currently employed for one of the following three reasons: i. newly enrolled in IPS and have not yet been placed in a job ii. have been enrolled in IPS for at least three months and have not yet obtained a job iii. have lost a job after enrollment in IPS and have not obtained a new job for at least a month following the loss of their last job.
- are fluent in English
- are able and willing to participate via Zoom in assessments and if necessary in intervention delivery
- agree that assessments and intervention sessions will be audio-recorded
Who cannot join
- 1. inability to give full and knowing consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03103
About this study
Official title: Mastering the World of Work (MWW): Randomized Controlled Trial
The purpose of this study is to conduct a randomized clinical trial for an innovative intervention entitled "Mastering the World of Work" (MWW). MWW aims to improve the employment outcomes of individuals with psychiatric disabilities who experience metacognitive deficits. Metacognitive deficits are represented in diminished capacity to form an integrated sense of self and others and respond to challenges in life. The randomized trial (N=60) will be conducted with recipients of Supported Employment (Individual Placement and Support) services at the Mental Health Center of Greater Manchester, in Manchester, NH. Given COVID-19 safety considerations, the MWW intervention will be delivered in a hybrid manner depending on the preferences of both clinicians and clients at the MHCGM at any given point of the study. The feasibility of remote delivery of the intervention has been established as part of a pilot study conducted at BU CPR. Thus, clinicians may deliver the intervention using HIPAA-complaint ZOOM connection and/or in person. The assessments will be administered at baseline, 6, 12, and 18 months post baseline remotely by BU staff using a HIPAA-complaint ZOOM connection. The RCT will establish preliminary evidence about the incremental effectiveness of the MWW intervention to improve the employment outcomes of individuals with metacognitive deficits who receive high fidelity IPS services. Study participants randomized to the control condition will receive IPS services as usual.
Read the detailed description
Mastering the World of Work (MWW) is a 29-session individual intervention comprised of 7 modules each covered in 4 sessions, and a wrap-up session. The 7 modules address: i) awareness of one's motivations to work; ii) awareness about personal work-related strengths and vulnerabilities; iii) balancing between work and mental health; iv) understanding experience of workplace prejudice and discrimination; v) understanding work-related challenges such as workload, time management, etc.; vi) understanding conflicts at work; and vii) thoughts and feelings about receiving disability benefits and their impact on work-related decisions. The last module is optional for individuals who receive disability benefits due to their psychiatric condition. Each session includes viewing a short video depicting the session's concept followed by a discussion of how it is applicable to the participant's life. Sessions can last up to one hour depending on participant's speed of covering the session's material. Findings from the feasibility study indicate that on average MWW sessions last between 30 and 45 minutes. Participants will complete a homework assignment related to each topic discussed in-between sessions; this will take participants an average of 15-20 minutes per week.
Participants in the randomized clinical trial will be offered to meet on a weekly basis with the MWW clinician assigned to work with them. Participants can choose to have the MWW sessions delivered remotely or in person in a flexible manner that fits the preferences and safety concerns of both the client and the clinician at any given point of the study. Participants will be able to meet in person at the MHCGM agency or remotely via a HIPAA-compliant Zoom connection. Participants will be reminded that MWW sessions will be audio-recorded and audio files will be shared with the BU research team for the purposes of supervision and fidelity assessment as indicated in the consent form the participants have signed.
The MWW intervention will be delivered in a flexible manner informed by the feasibility study conducted at BU CPR which demonstrated that it is important to schedule sessions depending on participants' personal situation and preferences. Occasionally, participants may need two meetings to cover the content of a given session or alternatively, may cover in one meeting the content of two sessions within a given module if the content is not particularly relevant to their personal situation (i.e., the participant reports not having experiences of prejudice and discrimination at work). Participants will be able to cover MWW modules out of order depending on their employment situation, i.e., a participant may choose to complete the module on conflict at work (module 6) earlier if that participant gets a job and right away encounters a conflict with a co-worker or a supervisor. Participants may reschedule meetings due to any personal/medical reasons or take a break due to changes in their employment situation (i.e., getting a full-time job). Clinicians will be available to meet with participants during all 18 months of their study participation. Once participants complete all relevant MWW modules, participants can still continue to meet with their clinician to go over some MWW content relevant to the participant's employment situation. Participants can schedule such follow-up sessions as frequently as necessary while accounting for their clinician's availability at the time of such requests.
Each participant will be in the study for 18 months and will complete a total of 4 assessments over the course of the study: at baseline, 6-month, 12-month and 18-month post-baseline. The baseline assessment will last approximately between 90 minutes and 2 hours and the follow-up assessments will take approximately 60 to 90 minutes.
The MWW intervention sessions will also be audio recorded. BU Research Staff will review a percentage of these recordings to assess fidelity, that is, to ensure that key components of the session were covered. The BU Research Staff will also review these recordings for the supervision of the clinicians delivering the MWW intervention.
- Conditions
- Mental Disorders, Employment, Metacognition, Employment, Supported
- Being tested
- Mastering the World of Work (MWW)
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastering the World of Work (MWW)Behavioural
Mastering the World of Work (MWW) is a 29-session individual intervention comprised of 7 modules each covered in 4 sessions, and a wrap-up session. Participants in the randomized clinical trial will be offered to meet on a weekly basis with the MWW clinician assigned to work with them.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Study participants randomized to the experimental condition will receive IPS services as usual in conjunction with the MWW intervention. Receives: Behavioral: Mastering the World of Work (MWW) |
| Control | No intervention | Study participants randomized to the control condition will receive IPS services as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employment Rates
Obtainment of a competitive job
Measured: 18 months
Employment Tenure
Number of weeks during which participant kept a job: remained on payroll either due to earned income (at least 1 hour of paid work) or used vacation and/or sick time.
Measured: 18 months
Secondary outcomes (1)
Metacognition Assessment Scale - Abbreviated (MAS-A)
Metacognition Assessment Scale - Abbreviated (MAS-A) is a rating scale measuring metacognitive capacity with 4 subscales assessing: a) self-reflectivity; b) awareness of the other's mind; c) decentration; and d) mastery. The scores for the overall MAS-A scale range between 0 and 28 with higher scores indicating higher level of metacognitive capacity. The scores for the MAS-A subscales range as follows with higher scores indicating higher level of specific metacognitive capacity: a) self-reflectivity - between 0 and 9; b) awareness of the other's mind - between 0 and 7; c) decentration - between 0 and 3; and d) mastery - between 0 and 9.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start24 Jun 2022
- Primary completion16 Sep 2026
- Study completion16 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- 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
- Study participants randomized to the experimental condition will receive IPS services in combination with the MWW intervention. Study participants randomized to the control condition will receive IPS services as usual.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zlatka Russinova, PhD, Principal investigator, Boston University Center for Psychiatric Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206188
- Sponsor's protocol ID
- 6377E
- Status last verified
- Sep 2026
- First submitted
- 14 Dec 2021
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will follow the guidance outlined in the Administration for Community Living (ACL) Public Access Plan for peer-reviewed publications and establishing public access to data. We will use the Interuniversity Consortium for Political and Social Research (ICPSR) as designated by ACL for archiving of data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastering the World of Work (MWW): Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05206188
- Acronym / sponsor ID
- 6377E
- Conditions
- Mental Disorders, Employment, Metacognition, Employment, Supported
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 16 Sep 2026 (actual)
- Study completion
- 16 Sep 2026 (actual)
- First posted
- 25 Jan 2022 (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.
The purpose of this study is to conduct a randomized clinical trial for an innovative intervention entitled "Mastering the World of Work" (MWW). MWW aims to improve the employment outcomes of individuals with psychiatric disabilities who experience metacognitive deficits. Metacognitive deficits are represented in diminished capacity to form an integrated sense of self and others and respond to challenges in life. The randomized trial (N=60) will be conducted with recipients of Supported Employment (Individual Placement and Support) services at the Mental Health Center of Greater Manchester, in Manchester, NH. Given COVID-19 safety considerations, the MWW intervention will be delivered in a hybrid manner depending on the preferences of both clinicians and clients at the MHCGM at any given point of the study. The feasibility of remote delivery of the intervention has been established as part of a pilot study conducted at BU CPR. Thus, clinicians may deliver the intervention using HIPAA-complaint ZOOM connection and/or in person. The assessments will be administered at baseline, 6, 12, and 18 months post baseline remotely by BU staff using a HIPAA-complaint ZOOM connection. The RCT will establish preliminary evidence about the incremental effectiveness of the MWW intervention to improve the employment outcomes of individuals with metacognitive deficits who receive high fidelity IPS services. Study participants randomized to the control condition will receive IPS services as usual.
Detailed description
Mastering the World of Work (MWW) is a 29-session individual intervention comprised of 7 modules each covered in 4 sessions, and a wrap-up session. The 7 modules address: i) awareness of one's motivations to work; ii) awareness about personal work-related strengths and vulnerabilities; iii) balancing between work and mental health; iv) understanding experience of workplace prejudice and discrimination; v) understanding work-related challenges such as workload, time management, etc.; vi) understanding conflicts at work; and vii) thoughts and feelings about receiving disability benefits and their impact on work-related decisions. The last module is optional for individuals who receive disability benefits due to their psychiatric condition. Each session includes viewing a short video depicting the session's concept followed by a discussion of how it is applicable to the participant's life. Sessions can last up to one hour depending on participant's speed of covering the session's material. Findings from the feasibility study indicate that on average MWW sessions last between 30 and 45 minutes. Participants will complete a homework assignment related to each topic discussed in-between sessions; this will take participants an average of 15-20 minutes per week.
Participants in the randomized clinical trial will be offered to meet on a weekly basis with the MWW clinician assigned to work with them. Participants can choose to have the MWW sessions delivered remotely or in person in a flexible manner that fits the preferences and safety concerns of both the client and the clinician at any given point of the study. Participants will be able to meet in person at the MHCGM agency or remotely via a HIPAA-compliant Zoom connection. Participants will be reminded that MWW sessions will be audio-recorded and audio files will be shared with the BU research team for the purposes of supervision and fidelity assessment as indicated in the consent form the participants have signed.
The MWW intervention will be delivered in a flexible manner informed by the feasibility study conducted at BU CPR which demonstrated that it is important to schedule sessions depending on participants' personal situation and preferences. Occasionally, participants may need two meetings to cover the content of a given session or alternatively, may cover in one meeting the content of two sessions within a given module if the content is not particularly relevant to their personal situation (i.e., the participant reports not having experiences of prejudice and discrimination at work). Participants will be able to cover MWW modules out of order depending on their employment situation, i.e., a participant may choose to complete the module on conflict at work (module 6) earlier if that participant gets a job and right away encounters a conflict with a co-worker or a supervisor. Participants may reschedule meetings due to any personal/medical reasons or take a break due to changes in their employment situation (i.e., getting a full-time job). Clinicians will be available to meet with participants during all 18 months of their study participation. Once participants complete all relevant MWW modules, participants can still continue to meet with their clinician to go over some MWW content relevant to the participant's employment situation. Participants can schedule such follow-up sessions as frequently as necessary while accounting for their clinician's availability at the time of such requests.
Each participant will be in the study for 18 months and will complete a total of 4 assessments over the course of the study: at baseline, 6-month, 12-month and 18-month post-baseline. The baseline assessment will last approximately between 90 minutes and 2 hours and the follow-up assessments will take approximately 60 to 90 minutes.
The MWW intervention sessions will also be audio recorded. BU Research Staff will review a percentage of these recordings to assess fidelity, that is, to ensure that key components of the session were covered. The BU Research Staff will also review these recordings for the supervision of the clinicians delivering the MWW intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants randomized to the experimental condition will receive IPS services in combination with the MWW intervention. Study participants randomized to the control condition will receive IPS services as usual.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Mastering the World of Work (MWW)Study participants randomized to the experimental condition will receive IPS services as usual in conjunction with the MWW intervention. |
| Control | No intervention | –Study participants randomized to the control condition will receive IPS services as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- are 18 or older
- have a DSM-IV diagnosis of serious mental illness, including dual diagnosis
- are currently receiving supported employment services (Individual Placement and Support) at the Mental Health Center of Greater Manchester, in Manchester, NH.
- are not currently employed for one of the following three reasons: i. newly enrolled in IPS and have not yet been placed in a job ii. have been enrolled in IPS for at least three months and have not yet obtained a job iii. have lost a job after enrollment in IPS and have not obtained a new job for at least a month following the loss of their last job.
- are fluent in English
Key exclusion criteria (1 listed)
- 1. inability to give full and knowing consent
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 |
|---|---|---|
| Mastering the World of Work (MWW)Mastering the World of Work (MWW) is a 29-session individual intervention comprised of 7 modules each covered in 4 sessions, and a wrap-up session. Participants in the randomized clinical trial will be offered to meet on a weekly basis with the MWW clinician assigned to work with them. | Behavioural | Experimental |
Primary outcome
Employment Rates
Time frame: 18 months
Obtainment of a competitive job
Employment Tenure
Time frame: 18 months
Number of weeks during which participant kept a job: remained on payroll either due to earned income (at least 1 hour of paid work) or used vacation and/or sick time.
1 secondary outcome
Metacognition Assessment Scale - Abbreviated (MAS-A)
Time frame: 18 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 22 Sep 2026.
- Individual participant dataSharing planned: Yes. We will follow the guidance outlined in the Administration for Community Living (ACL) Public Access Plan for peer-reviewed publications and establishing public access to data. We will use the Interuniversity Consortium for Political and Social Research (ICPSR) as designated by ACL for archiving of data.
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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.
Zlatka Russinova, PhD principal investigator
Boston University Center for Psychiatric Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mastering the World of Work (MWW) in people with Mental Disorders and Employment, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Employment Rates (time frame: 18 months). The study lists 2 primary outcomes in all. 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 22 Sep 2026.