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Clinical Trials/NCT00520728
NCT00520728CompletedPhase 1

Efficacy of an Occupational Time Use Intervention

Queen's University0 sites18 target enrollmentStarted: August 2007Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
18
Primary Endpoint
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.

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Clinical Utility using feedback from Therapists and Treatment Subjects(Participants were tested after 12 weeks of treatment.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Megan Edgelow

Principal Investigator

Queen's University

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