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

NCT05869409 | Unknown

• 1 other identifier: SWPS_01/P/01/2020
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders; Affective Disorder

Keywords

Physical Activity; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Positive Symptoms (Psychosis)

  change from the baseline positive symptoms at 6 weeks

• Negative Symptoms (Psychosis)

  change from the baseline negative symptoms at 6 weeks

• General Psychopathology Symptoms )Psychosis)

  change from the baseline general psychopathology symptoms at 6 weeks

• Depression symptoms

  change from baseline depression symptoms at 6 weeks

• Physical activity

  change from baseline physical activity at 6 weeks

Study Arms (1)

People diagnosed with a psychotic disorder or an affective disorder

Behavioral: Physical activity and sedentary behavior education

Interventions

Physical activity and sedentary behavior education BEHAVIORAL

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).

People diagnosed with a psychotic disorder or an affective disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- a diagnosis of a psychotic disorder or affective disorder

You may not qualify if:

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

Sponsors & Collaborators

• University of Social Sciences and Humanities, Warsaw: lead

Study Sites (1)

SWPS University, Faculty of Psychology in Wroclaw

Wroclaw, Lower Silezia, 53-238, Poland

RECRUITING

Related 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.

  PMID: 9626712 BACKGROUND

• 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.

  PMID: 30967483 BACKGROUND

• 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.

  PMID: 3616518 BACKGROUND

• 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.

  PMID: 22018588 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Mood Disorders; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Aleksandra Luszczynska, PhD

CONTACT

0048604576066; aluszczynska@swps.edu.pl

Ernest Swora, MA

CONTACT

eswora@swps.edu.pl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 22, 2023
• Study Start: May 1, 2022
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After data exploitation by the researchers involved in data collection.

Locations

PL (1)