ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00520728
Recruitment Status : Completed
First Posted : August 24, 2007
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
Megan Edgelow, Queen's University

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.

Condition or disease Intervention/treatment Phase
Serious Mental Illness Behavioral: Occupational Time Use Intervention Phase 1

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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of an Occupational Time Use Intervention
Study Start Date : August 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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. ]
  2. 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 Measures :
  1. Clinical Utility using feedback from Therapists and Treatment Subjects [ Time Frame: Participants were tested after 12 weeks of treatment. ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520728


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

Responsible Party: Megan Edgelow, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00520728     History of Changes
Other Study ID Numbers: OTUI1
First Posted: August 24, 2007    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Mental Disorders