NCT07035210

Brief Summary

The goal of this study is to determine if supporting forensic patients in setting their own goals can impact occupational deprivation. This study is guided by this overarching research question: can setting and achieving self-directed goals improve occupational deprivation outcomes in long-term patients of a forensic psychiatric hospital? Participants were provided an educational group and occupational therapy treatment sessions to support goal setting within the forensic hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 25, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 27, 2025

Last Update Submit

June 14, 2025

Conditions

Occupational DeprivationForensic Mental Health

Keywords

Long-term patientsForensic patientsMental health patientsOccupational deprivationSelf-directed goals

Outcome Measures

Primary Outcomes (1)

  • Canadian Occupational Performance Measure

    Semi-structured interview identifying occupational participation. Participants rate occupations identified based on importance, performance, and satisfaction.

    At enrollment and week 11

Study Arms (1)

Self-directed Goals

EXPERIMENTAL

Participants will be setting self-directed goals based on the Canadian Occupational Performance Measure in skilled 1:1 occupational therapy sessions and working to achieving them as well as attending a goal-setting educational group.

Behavioral: Group and 1:1 occupational therapy sessions

Interventions

Group and 1:1 occupational therapy sessionsBEHAVIORAL

Patients will be educated on the goal setting process and setting self-directed goals aimed at occupations they identified as important in both group and 1:1 treatment sessions.

Self-directed Goals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is capable of providing consent to participate.
  • Is at least 18 years of age.
  • Resides at Rhode Island State Psychiatric Hospital.
  • Hospital stay for a year or longer as of the anticipated start date of January 2025.
  • No imminent discharge date due to the nature of their alleged criminal charges or current symptoms of their mental illness.

You may not qualify if:

  • Have an imminent discharge date
  • Having experienced positive symptoms of psychosis (i.e hallucinations, delusions, or thought disorganization) in the year prior to the January start date.
  • Behavioral outburst resulting in restraints in the year prior to the January start date.
  • Hold a primary diagnosis of antisocial personality disorder (ASPD).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island State Psychiatric Hospital

Cranston, Rhode Island, 02920, United States

Location

Related Publications (5)

  • Stephenson T, Leaman J, O'Moore E, Tran A, Plugge E. Time out of cell and time in purposeful activity and adverse mental health outcomes amongst people in prison: a literature review. Int J Prison Health. 2021 Jan 6;17(1):54-68. doi: 10.1108/IJPH-06-2020-0037.

    PMID: 33634654BACKGROUND

  • Romero-Ayuso DM, Toledano-Gonzalez A, Pinilla-Cerezo M, Sanchez-Rodriguez O, Garcia-Arenas JJ, Trivino-Juarez JM, Ortiz-Rubio A. Occupational Balance and Emotional Regulation in People With and Without Serious Mental Illness. Can J Occup Ther. 2024 Mar;91(1):100-109. doi: 10.1177/00084174231178440. Epub 2023 Jun 4.

    PMID: 37271981BACKGROUND

  • Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S. Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Can J Occup Ther. 1994 Oct;61(4):191-7. doi: 10.1177/000841749406100403.

    PMID: 10137673BACKGROUND

  • Laverdure P, Beisbier S. Occupation- and Activity-Based Interventions to Improve Performance of Activities of Daily Living, Play, and Leisure for Children and Youth Ages 5 to 21: A Systematic Review. Am J Occup Ther. 2021 Jan-Feb;75(1):7501205050p1-7501205050p24. doi: 10.5014/ajot.2021.039560.

    PMID: 33399053BACKGROUND

  • Clarke, C. (2003). Clinical application of the Canadian Model of Occupational Performance in a forensic rehabilitation hostel. British Journal of Occupational Therapy, 66(4).

    BACKGROUND

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Occupational Therapy Doctoral Student

Study Record Dates

First Submitted

February 27, 2025

First Posted

June 25, 2025

Study Start

January 6, 2025

Primary Completion

April 4, 2025

Study Completion

April 20, 2025

Last Updated

June 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)