Serious Mental IllnessPhase 1NCT00520728
Efficacy of an Occupational Time Use Intervention for People With Serious Mental Illness
A Phase 1 study testing Occupational Time Use Intervention in people with Serious Mental Illness, run by Queen's University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Serious Mental Illness
- What is being tested?
- Occupational Time Use Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Efficacy of an Occupational Time Use Intervention
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
- Conditions
- Serious Mental Illness
- Being tested
- Occupational Time Use Intervention
- Keywords
- Schizophrenia, Psychosis, Occupational Disengagement, Occupational Imbalance
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Time Use InterventionBehavioural
12 week behavioral intervention administered by Occupational Therapists.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Experimental arm receives 12 week intervention along with standard care. Receives: Behavioral: Occupational Time Use Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Activity Level using a 2 day (48 hour) time use diary
Measured: 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.
Measured: Participants were tested at baseline and after 12 weeks of treatment.
Secondary outcomes (1)
Clinical Utility using feedback from Therapists and Treatment Subjects
Measured: Participants were tested after 12 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Edgelow, Queen's University
- Investigators
- Megan M Edgelow, MSc, Principal investigator, Queen's UniversityTerry Krupa, PhD, Study director, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520728
- Sponsor's protocol ID
- OTUI1
- Status last verified
- Sep 2015
- First submitted
- 22 Aug 2007
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Occupational Time Use Intervention
- ClinicalTrials.gov ID
- NCT00520728
- Acronym / sponsor ID
- OTUI1
- Conditions
- Serious Mental Illness
- Keywords
- Schizophrenia, Psychosis, Occupational Disengagement, Occupational Imbalance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 24 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Occupational Time Use InterventionExperimental arm receives 12 week intervention along with standard care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational Time Use Intervention12 week behavioral intervention administered by Occupational Therapists. | Behavioural | A |
Primary outcome
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.
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.
1 secondary outcome
Clinical Utility using feedback from Therapists and Treatment Subjects
Time frame: Participants were tested after 12 weeks of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan M Edgelow, MSc principal investigator
Queen's University
Terry Krupa, PhD study director
Queen's University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Occupational Time Use Intervention in people with Serious Mental Illness, run by Queen's University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015; AzTrials last refreshed its copy on 6 Nov 2026.