Efficacy of an Occupational Time Use Intervention for People With Serious Mental Illness

September 1, 2015 updated by: Megan Edgelow, Queen's University

Efficacy of an Occupational Time Use Intervention

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Experimental arm receives 12 week intervention along with standard care.
Behavioral: Occupational Time Use Intervention
12 week behavioral intervention administered by Occupational Therapists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Participants were tested at baseline and after 12 weeks of treatment.
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.
Participants were tested at baseline and after 12 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Utility using feedback from Therapists and Treatment Subjects
Time Frame: Participants were tested after 12 weeks of treatment.
Participants were tested after 12 weeks of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's University

Investigators

  • Principal Investigator: Megan M Edgelow, MSc, Queen's University
  • Study Director: Terry Krupa, PhD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 22, 2007

First Submitted That Met QC Criteria

August 22, 2007

First Posted (Estimate)

August 24, 2007

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTUI1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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