Clinical trial NCT05869409: Physical Activity, Psychopathology, and Quality of Life in People With Psychotic or Affective Disorders
Official title: The Relationships Between Physical Activity, Psychopathological Symptoms, and Health-Related Quality of Life in People Diagnosed With Psychotic or Affective Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psychotic Disorders
Affective Disorder
Keywords: Physical Activity
Quality of Life
Lead sponsor: University of Social Sciences and Humanities, Warsaw
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health-Related Quality of Life
timeFrame: change from the baseline health-related quality of life at 6 weeks
Secondary outcomes:
measure: Positive Symptoms (Psychosis)
timeFrame: change from the baseline positive symptoms at 6 weeks
measure: Negative Symptoms (Psychosis)
timeFrame: change from the baseline negative symptoms at 6 weeks
measure: General Psychopathology Symptoms )Psychosis)
timeFrame: change from the baseline general psychopathology symptoms at 6 weeks
measure: Depression symptoms
timeFrame: change from baseline depression symptoms at 6 weeks
measure: Physical activity
timeFrame: change from baseline physical activity at 6 weeks
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: SWPS University, Faculty of Psychology in Wroclaw
state: Lower Silezia
Study officials:
References:
citation: 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.
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.
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.
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.