NCT02648321

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
Last Updated

January 7, 2016

Status Verified

January 1, 2016

Enrollment Period

1.9 years

First QC Date

December 10, 2015

Last Update Submit

January 5, 2016

Conditions

Psychotic Disorders

Keywords

Motivational InterviewingExercise

Outcome Measures

Primary Outcomes (1)

  • Physical Activity Level

    12 weeks

Secondary Outcomes (4)

  • Role Functioning Scale

    12 weeks

  • Short Form 36

    12 weeks

  • PANSS

    12 weeks

  • Physical Activity Level

    24 weeks

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Motivational Interviewing

Behavioral: Motivational Interviewing

Health Education

ACTIVE COMPARATOR

Health Education

Behavioral: Health Education

Interventions

Motivational InterviewingBEHAVIORAL

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.

Motivational Interviewing
Health EducationBEHAVIORAL

General education about healthy lifestyle and diet.

Health Education

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Psychotic DisordersMotor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2015

First Posted

January 7, 2016

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 7, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)