Physical Activity, Psychopathology, and Quality of Life in People With Psychotic or Affective Disorders

May 18, 2023 updated by: University of Social Sciences and Humanities, Warsaw

The Relationships Between Physical Activity, Psychopathological Symptoms, and Health-Related Quality of Life in People Diagnosed With Psychotic or Affective Disorders

This longitudinal observational study tests the associations between physical activity, health-related quality of life, and psychopathology symptoms among people diagnosed with schizophrenia or diagnosed with affective disorders. It was assumed that higher levels of physical activity at baseline will be related to better quality of life (across physical, social, and psychological domains), and lower psychopathology symptoms (positive and negative symptoms of psychosis, general psychopathology, and depression severity) at 6-week follow-up measurement. Adult participants with a diagnosis of a psychotic disorder or a diagnosis of an affective disorder will be enrolled.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Lower Silezia
      • Wroclaw, Lower Silezia, Poland, 53-238
        • Recruiting
        • SWPS University, Faculty of Psychology in Wroclaw
        • Contact:
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

People who are participating in rehabilitation programs for individuals diagnosed with psychosis and/or affective disorders will be recruited in out-patient rehabilitation clinics. Patients treated at with pharmacotherapy and/or psychotherapy for individuals diagnosed with psychosis and/or affective disorders will be recruited in out-patient clinics.

Description

Inclusion Criteria:

- a diagnosis of a psychotic disorder or affective disorder

Exclusion Criteria:

  • major cognitive deficits, indicated by total scores > 8 points, obtained with the Montreal Cognitive Assessment (MoCA) Scale at baseline

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
People diagnosed with a psychotic disorder or an affective disorder
Behavioral: Physical activity and sedentary behavior education
Enrolled patients will participate in an individual face-to-face education session, addressing: definitions and examples of sedentary and physical activity behaviors; physical health-related and mental health-related consequences of these behaviors; ways to break sedentary behaviors; age-adjusted physical activity recommendations (based on the guidelines of the World Health Organization).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-Related Quality of Life
Time Frame: change from the baseline health-related quality of life at 6 weeks
scores (range 0-100) obtained in the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF); higher scores indicate better quality of life
change from the baseline health-related quality of life at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Symptoms (Psychosis)
Time Frame: change from the baseline positive symptoms at 6 weeks
scores obtained with Positive and Negative Syndrome Scales (PANSS): Positive Symptoms subscale, scores range: 7-49; higher scores indicate more symptoms
change from the baseline positive symptoms at 6 weeks
Negative Symptoms (Psychosis)
Time Frame: change from the baseline negative symptoms at 6 weeks
scores obtained with Positive and Negative Syndrome Scales (PANSS): Negative Symptoms subcale, scores range: 7-49, higher scores indicate more symptoms
change from the baseline negative symptoms at 6 weeks
General Psychopathology Symptoms )Psychosis)
Time Frame: change from the baseline general psychopathology symptoms at 6 weeks
scores obtained with Positive and Negative Syndrome Scales (PANSS): General Psychopathology subscale, scores range: 16-112, higher symptoms indicate more symptoms
change from the baseline general psychopathology symptoms at 6 weeks
Depression symptoms
Time Frame: change from baseline depression symptoms at 6 weeks
scores obtained in Patient Health Questionnaire -9 (PHQ-9); scores range: 0-36; higher scores indicate more severe symptoms of depression
change from baseline depression symptoms at 6 weeks
Physical activity
Time Frame: change from baseline physical activity at 6 weeks
minutes of physical activity per week measured with International Physical Activity Questionnaire - Short Form (IPAQ-Short Form); more minutes indicate more time spent on light, moderate, or high-intensity physical activity
change from baseline physical activity at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Social Sciences and Humanities, Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 1, 2022

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 18, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SWPS_01/P/01/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized data will be made open and deposited at Open Science Framework repository. Anonymized data will include aggregated (sum) scores for all outcome measures.

IPD Sharing Time Frame

After data exploitation by the researchers involved in data collection.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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