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

Psychotic Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05869409
• Other study ID #: SWPS_01/P/01/2020
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: University of Social Sciences and Humanities, Warsaw
• Contact: Aleksandra Luszczynska, PhD
• Phone: 0048604576066
• Email: aluszczynska[@]swps.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Affective Disorder
• Disease
• Mental Disorders
• Mood Disorders
• Psychotic Disorders

Intervention

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).

Locations

Country	Name	City	State
Poland	SWPS University, Faculty of Psychology in Wroclaw	Wroclaw	Lower Silezia

Sponsors (1)

Lead Sponsor	Collaborator
University of Social Sciences and Humanities, Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (4)

Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667. — View Citation

Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261. — View Citation

Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115. — View Citation

Levis B, Benedetti A, Thombs BD; DEPRESsion Screening Data (DEPRESSD) Collaboration. Accuracy of Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis. BMJ. 2019 Apr 9;365:l1476. doi: 10.1136/bmj.l1476. Erratum In: BMJ. 2019 Apr 12;365:l1781. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-Related Quality of Life	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	Positive Symptoms (Psychosis)	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
Secondary	Negative Symptoms (Psychosis)	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
Secondary	General Psychopathology Symptoms )Psychosis)	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
Secondary	Depression symptoms	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
Secondary	Physical activity	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