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

This study has been completed.
Sponsor:
Information provided by:
Queen's University
ClinicalTrials.gov Identifier:
NCT00520728
First received: August 22, 2007
Last updated: June 24, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Serious Mental Illness
Behavioral: Occupational Time Use Intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of an Occupational Time Use Intervention

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Change in Activity Level using a 2 day (48 hour) time use diary [ Time Frame: Pre-test and Post-test ] [ Designated as safety issue: No ]
  • 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: Pre-test and Post-test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Utility using feedback from Therapists and Treatment Subjects [ Time Frame: Post-test ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: August 2007
Study Completion Date: June 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520728

Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Megan M Edgelow, BScOT Queen's University
Study Director: Terry Krupa, PhD Queen's University
  More Information

No publications provided

Responsible Party: Megan Edgelow, Queen's University
ClinicalTrials.gov Identifier: NCT00520728     History of Changes
Other Study ID Numbers: OTUI1
Study First Received: August 22, 2007
Last Updated: June 24, 2008
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
Schizophrenia
Psychosis
Occupational Disengagement
Occupational Imbalance

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014