Back to resultsEfficacy of an Occupational Time Use Intervention for People With Serious Mental Illness
Primary Purpose
Serious Mental Illness
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Occupational Time Use Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Serious Mental Illness focused on measuring Schizophrenia, Psychosis, Occupational Disengagement, Occupational Imbalance
Eligibility Criteria
Inclusion Criteria:
- Adults (18-65 years of age);
- Primary diagnosis of a severe psychiatric disorder with a psychotic feature;
- Team and self-perceived occupational disengagement (low activity levels);
- Fluent in English;
- Living in a community setting and receiving ACT treatment;
- Own legal guardian (thus competent to give consent to participate), and are willing to give written informed consent to participate in the study.
Exclusion Criteria:
- Unstable mental health;
- Lack of interest in a time use intervention;
- Satisfied with current time use and occupations;
- ACT Team Occupational Therapist is subject's main Case Manager.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Experimental arm receives 12 week intervention along with standard care.
Outcomes
Primary Outcome Measures
Change in Activity Level using a 2 day (48 hour) time use diary
Occupational Engagement using 1. 48 hour time use diary for occupational balance, 2. Engagement in Meaningful Activities Survey (EMAS) for meaning of activities, and 3. Profiles of Engagement in People with Schizophrenia (POES) to rate engagement.
Secondary Outcome Measures
Clinical Utility using feedback from Therapists and Treatment Subjects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00520728
Brief Title
Efficacy of an Occupational Time Use Intervention for People With Serious Mental Illness
Official Title
Efficacy of an Occupational Time Use Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to test the efficacy of a new Occupational Time Use Intervention designed to increase activity participation and improve meaning in the lives of people with serious mental illness living in the community.
Detailed Description
5 Assertive Community Treatment (ACT) Teams from Kingston (n=2), Belleville (n=1), and Ottawa (n=2) will be involved in a 12 week randomized controlled trial of our Time Use Intervention. 20 subjects (4 subjects from each team) will participate in this pilot study and will be treated individually by their ACT team Occupational Therapist (1 OT per ACT Team). This pilot test will help to determine the clinical utility and efficacy of our treatment protocol.
Comparison: Standard ACT treatment with the Occupational Time Use Intervention vs. Standard ACT treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serious Mental Illness
Keywords
Schizophrenia, Psychosis, Occupational Disengagement, Occupational Imbalance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Experimental arm receives 12 week intervention along with standard care.
Intervention Type
Behavioral
Intervention Name(s)
Occupational Time Use Intervention
Intervention Description
12 week behavioral intervention administered by Occupational Therapists.
Primary Outcome Measure Information:
Title
Change in Activity Level using a 2 day (48 hour) time use diary
Time Frame
Participants were tested at baseline and after 12 weeks of treatment.
Title
Occupational Engagement using 1. 48 hour time use diary for occupational balance, 2. Engagement in Meaningful Activities Survey (EMAS) for meaning of activities, and 3. Profiles of Engagement in People with Schizophrenia (POES) to rate engagement.
Time Frame
Participants were tested at baseline and after 12 weeks of treatment.
Secondary Outcome Measure Information:
Title
Clinical Utility using feedback from Therapists and Treatment Subjects
Time Frame
Participants were tested after 12 weeks of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (18-65 years of age);
Primary diagnosis of a severe psychiatric disorder with a psychotic feature;
Team and self-perceived occupational disengagement (low activity levels);
Fluent in English;
Living in a community setting and receiving ACT treatment;
Own legal guardian (thus competent to give consent to participate), and are willing to give written informed consent to participate in the study.
Exclusion Criteria:
Unstable mental health;
Lack of interest in a time use intervention;
Satisfied with current time use and occupations;
ACT Team Occupational Therapist is subject's main Case Manager.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan M Edgelow, MSc
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terry Krupa, PhD
Organizational Affiliation
Queen's University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy of an Occupational Time Use Intervention for People With Serious Mental Illness
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