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

NCT00520728 | Completed Phase 1 DMC

• 1 other identifier: OTUI1
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Serious Mental Illness

Keywords

Schizophrenia; Psychosis; Occupational Disengagement; Occupational Imbalance

Outcome Measures

Primary Outcomes (2)

• Change in Activity Level using a 2 day (48 hour) time use diary

  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.

  Participants were tested at baseline and after 12 weeks of treatment.

Secondary Outcomes (1)

• Clinical Utility using feedback from Therapists and Treatment Subjects

  Participants were tested after 12 weeks of treatment.

Study Arms (1)

A

EXPERIMENTAL

Experimental arm receives 12 week intervention along with standard care.

Behavioral: Occupational Time Use Intervention

Interventions

Occupational Time Use Intervention BEHAVIORAL

12 week behavioral intervention administered by Occupational Therapists.

A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Megan M Edgelow, MSc

  Queen's University

  PRINCIPAL INVESTIGATOR

• Terry Krupa, PhD

  Queen's University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2007
• First Posted: August 24, 2007
• Study Start: August 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 2, 2015

Record last verified: 2015-09