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

Serious Mental Illness Clinical Trial

Official title:

Efficacy of an Occupational Time Use Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520728
• Other study ID #: OTUI1
• 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

• Mental Disorders
• Serious Mental Illness

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