Mastering the World of Work (MWW): RCT
Primary Purpose
Mental Disorders, Employment, Metacognition
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mastering the World of Work (MWW)
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorders
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
1. inability to give full and knowing consent
Sites / Locations
- Mental Health Center of Greater ManchesterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
Study participants randomized to the experimental condition will receive IPS services as usual in conjunction with the MWW intervention.
Study participants randomized to the control condition will receive IPS services as usual.
Outcomes
Primary Outcome Measures
Employment Rates
Obtainment of a competitive job
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05206188
First Posted
December 14, 2021
Last Updated
July 28, 2023
Sponsor
Boston University Charles River Campus
1. Study Identification
Unique Protocol Identification Number
NCT05206188
Brief Title
Mastering the World of Work (MWW): RCT
Official Title
Mastering the World of Work (MWW): Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University Charles River Campus
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Employment, Metacognition, Employment, Supported
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Study participants randomized to the experimental condition will receive IPS services as usual in conjunction with the MWW intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Study participants randomized to the control condition will receive IPS services as usual.
Intervention Type
Behavioral
Intervention Name(s)
Mastering the World of Work (MWW)
Intervention 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. Participants in the randomized clinical trial will be offered to meet on a weekly basis with the MWW clinician assigned to work with them.
Primary Outcome Measure Information:
Title
Employment Rates
Description
Obtainment of a competitive job
Time Frame
18 months
Title
Employment Tenure
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Metacognition Assessment Scale - Abbreviated (MAS-A)
Description
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.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
1. inability to give full and knowing consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Bloch, MEd
Phone
617-353-5141
Email
bloch@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sue Guarino, RNBC
Phone
603-668-4111
Ext
5301
Email
guarinos@mhcgm.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zlatka Russinova, PhD
Organizational Affiliation
Boston University Center for Psychiatric Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Center of Greater Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Guarino, RNBC
Phone
603-668-4111
Ext
5301
Email
guarinos@mhcgm.org
First Name & Middle Initial & Last Name & Degree
Jonnica Donnelly, B.A.
Phone
603-668-4111
Email
donnellj@mhcgm.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will be shared upon study completion without availability limits.
IPD Sharing Access Criteria
Not available yet.
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Mastering the World of Work (MWW): RCT
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