Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05206188 |
| Other study ID # |
6377E |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 24, 2022 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Boston University Charles River Campus |
| Contact |
Philippe Bloch, MEd |
| Phone |
617-353-5141 |
| Email |
bloch[@]bu.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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.
