Psychotic DisordersNCT02648321
Motivational Intervention for Physical Activity in Psychosis
A study testing Motivational Interviewing and Health Education in people with Psychotic Disorders, run by The University of Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to determine whether motivational intervention is effective in promoting exercise habit in patients with psychosis. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Psychotic Disorders
- What is being tested?
- Motivational Interviewing and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Aug 2015
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychotic Disorders
- Being tested
- Motivational Interviewing, Health Education
- Keywords
- Motivational Interviewing, Exercise
- Medical subject headings
- Psychotic Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
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.
Health EducationBehavioural
General education about healthy lifestyle and diet.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Motivational Interviewing Receives: Behavioral: Motivational Interviewing |
| Health Education | Active comparator | Health Education Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
Measured: 12 weeks
Secondary outcomes (4)
Role Functioning Scale
Measured: 12 weeks
Short Form 36
Measured: 12 weeks
PANSS
Measured: 12 weeks
Physical Activity Level
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648321
- Sponsor's protocol ID
- UW 13-482
- Status last verified
- Jan 2016
- First submitted
- 10 Dec 2015
- Last updated
- 7 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Intervention of Exercise in Patients With Psychosis
- ClinicalTrials.gov ID
- NCT02648321
- Acronym / sponsor ID
- UW 13-482
- Conditions
- Psychotic Disorders
- Keywords
- Motivational Interviewing, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 Jan 2016 (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 determine whether motivational intervention is effective in promoting exercise habit in patients with psychosis.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingMotivational Interviewing |
| Health Education | Active comparator | Behavioral: Health EducationHealth Education |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Motivational InterviewingMotivational 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. | Behavioural | Motivational Interviewing |
| Health EducationGeneral education about healthy lifestyle and diet. | Behavioural | Health Education |
Primary outcome
Physical Activity Level
Time frame: 12 weeks
4 secondary outcomes
Role Functioning Scale
Time frame: 12 weeks
Short Form 36
Time frame: 12 weeks
PANSS
Time frame: 12 weeks
Physical Activity Level
Time frame: 24 weeks
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 7 Jan 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Health Education in people with Psychotic Disorders, run by The University of Hong Kong at 1 site in China.
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 3 inclusion and 6 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Physical Activity Level (time frame: 12 weeks). 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 7 Jan 2016.