Mastering the World of Work (MWW): RCT

NCT05206188 | Unknown

• 1 other identifier: 6377E
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorders; Employment; Metacognition; Employment, Supported

Outcome Measures

Primary Outcomes (2)

• Employment Rates

  Obtainment of a competitive job

  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.

  18 months

Secondary Outcomes (1)

• Metacognition Assessment Scale - Abbreviated (MAS-A)

  18 months

Study Arms (2)

Experimental

EXPERIMENTAL

Study participants randomized to the experimental condition will receive IPS services as usual in conjunction with the MWW intervention.

Behavioral: Mastering the World of Work (MWW)

Control

NO INTERVENTION

Study participants randomized to the control condition will receive IPS services as usual.

Interventions

Mastering the World of Work (MWW) BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \. inability to give full and knowing consent

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Mental Health Center of Greater Manchester

Manchester, New Hampshire, 03103, United States

RECRUITING

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Zlatka Russinova, PhD

  Boston University Center for Psychiatric Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Bloch, MEd

CONTACT

617-353-5141; bloch@bu.edu

Sue Guarino, RNBC

CONTACT

603-668-4111; guarinos@mhcgm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 25, 2022
• Study Start: June 24, 2022
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be shared upon study completion without availability limits.
• Access Criteria: Not available yet.

Locations

US (1)