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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00520728
Other study ID # OTUI1
Secondary ID
Status Completed
Phase Phase 1
First received August 22, 2007
Last updated September 1, 2015
Start date August 2007
Est. completion date June 2008

Study information

Verified date September 2015
Source Queen's University
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date June 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Occupational Time Use Intervention
12 week behavioral intervention administered by Occupational Therapists.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Queen's University

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Activity Level using a 2 day (48 hour) time use diary Participants were tested at baseline and after 12 weeks of treatment. No
Primary 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. Participants were tested at baseline and after 12 weeks of treatment. No
Secondary Clinical Utility using feedback from Therapists and Treatment Subjects Participants were tested after 12 weeks of treatment. No
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