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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02648321
Other study ID # UW 13-482
Secondary ID
Status Completed
Phase N/A
First received December 10, 2015
Last updated January 5, 2016
Start date September 2013
Est. completion date August 2015

Study information

Verified date January 2016
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether motivational intervention is effective in promoting exercise habit in patients with psychosis.


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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 64 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
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.
Health Education
General education about healthy lifestyle and diet.

Locations

Country Name City State
China The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Activity Level 12 weeks No
Secondary Role Functioning Scale 12 weeks No
Secondary Short Form 36 12 weeks No
Secondary PANSS 12 weeks No
Secondary Physical Activity Level 24 weeks No
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