- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02648321
Motivational Intervention for Physical Activity in Psychosis
January 5, 2016 updated by: The University of Hong Kong
Motivational Intervention of Exercise in Patients With Psychosis
The purpose of this study is to determine whether motivational intervention is effective in promoting exercise habit in patients with psychosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The current study aims to investigate the beneficial effect of motivational intervention in promoting exercise habit in patients with psychosis.
Outpatients will be recruited and will be randomized to a 12-week motivational intervention program.
They will be assessed for their clinical symptoms, cognitive function, physical fitness, and quality of life.
All patients will have cognitive function assessments at baseline, 12 weeks after the completion of the program and 6 months.
The primary hypothesis of the current study is that motivational intervention can help patient to develop exercise habit in patients with early psychosis.
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China
- The University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed to have psychotic disorders
- Cantonese-speaking Chinese (to enable cognitive testing)
- Ability to understand the nature of the study and to give written informed consent
Exclusion Criteria:
- Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise may be contraindicated), and seizure disorders
- Comorbid substance dependence
- Unstable psychotic symptoms
- Known pregnancy
- A history of brain trauma or organic brain disease
- Known history of intellectual disability or special school attendance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motivational Interviewing
|
Motivational Interviewing is a patient-centered, tailored counselling intervention for exercise, through which patients' motives to change are identified.
Personal ideas and ambivalence are explored.
The discrepancies between the present behavior and the patient's own future goals are amplified.
The patient's intrinsic motivation for change is increased through the process.
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Active Comparator: Health Education
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General education about healthy lifestyle and diet.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Physical Activity Level
Time Frame: 12 weeks
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Role Functioning Scale
Time Frame: 12 weeks
|
12 weeks
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Short Form 36
Time Frame: 12 weeks
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12 weeks
|
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PANSS
Time Frame: 12 weeks
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12 weeks
|
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Physical Activity Level
Time Frame: 24 weeks
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24 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
December 10, 2015
First Submitted That Met QC Criteria
January 5, 2016
First Posted (Estimate)
January 7, 2016
Study Record Updates
Last Update Posted (Estimate)
January 7, 2016
Last Update Submitted That Met QC Criteria
January 5, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UW 13-482
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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