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

Sponsor
University of Social Sciences and Humanities, Warsaw (Other)
Overall Status
Recruiting
CT.gov ID
NCT05869409
Collaborator
(none)
60
1
43
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Physical activity and sedentary behavior education

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Relationships Between Physical Activity, Psychopathological Symptoms, and Health-Related Quality of Life in People Diagnosed With Psychotic or Affective Disorders
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. Health-Related Quality of Life [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

Secondary Outcome Measures

  1. Positive Symptoms (Psychosis) [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

  2. Negative Symptoms (Psychosis) [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

  3. General Psychopathology Symptoms )Psychosis) [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

  4. Depression symptoms [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

  5. Physical activity [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 SWPS University, Faculty of Psychology in Wroclaw Wroclaw Lower Silezia Poland 53-238

Sponsors and Collaborators

  • University of Social Sciences and Humanities, Warsaw

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Social Sciences and Humanities, Warsaw
ClinicalTrials.gov Identifier:
NCT05869409
Other Study ID Numbers:
  • SWPS_01/P/01/2020
First Posted:
May 22, 2023
Last Update Posted:
May 22, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Social Sciences and Humanities, Warsaw
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2023