ClinicalTrials.gg
CompletedNCT00520728Updated Sep 2, 2015

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

A Phase 1 interventional study of Occupational Time Use Intervention in Serious Mental Illness, sponsored by Queen's University. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-09-02.

Sponsored by Queen's University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Serious Mental Illness

Keywords

  • Schizophrenia
  • Psychosis
  • Occupational Disengagement
  • Occupational Imbalance
03

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's enrollment of 18 is below the median of 70 across 2,924 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Queen's University is the lead sponsor of 207 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    A

    Experimental arm receives 12 week intervention along with standard care.

    Behavioral: Occupational Time Use Intervention

Interventions

  • BehavioralOccupational Time Use Intervention

    12 week behavioral intervention administered by Occupational Therapists.

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Clinical Utility using feedback from Therapists and Treatment Subjects

    Time frame: Participants were tested after 12 weeks of treatment.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2007, a primary completion of May 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2007
First posted
Aug 24, 2007
Start
Aug 2007
Primary completionActual
May 2008
CompletionActual
Jun 2008
Last update
Sep 2, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00520728
Lead sponsor
Queen's University
Responsible party
Megan Edgelow (Principal Investigator, Queen's University) — Principal investigator
First posted
Aug 24, 2007
Start date
Aug 2007
Primary completion
May 2008
Completion
Jun 2008
Last update
Sep 2, 2015

Study contacts

Megan M Edgelow, MSc
principal investigator · Queen's University
Terry Krupa, PhD
study director · Queen's University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion