Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05869409
Other study ID # SWPS_01/P/01/2020
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Terminated NCT03230097 - This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year Phase 2
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Active, not recruiting NCT05726617 - Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders N/A
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Recruiting NCT02874573 - Tocilizumab in Schizophrenia Phase 1
Completed NCT02906553 - The Role of Nitric Oxide in Cognition in Schizophrenia N/A
Terminated NCT02584114 - Brain Effects of Memory Training in Early Psychosis N/A
Completed NCT01981356 - Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis Phase 0
Withdrawn NCT02213887 - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications Phase 4
Terminated NCT02841956 - Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement N/A
Recruiting NCT02009969 - Serial Comparisons of Abdominal and Neurological MRI Scans N/A
Recruiting NCT02848469 - Irish Omega-3 Study Phase 2
Completed NCT02648321 - Motivational Intervention for Physical Activity in Psychosis N/A
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository
Completed NCT00484302 - Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis N/A
Completed NCT00130923 - Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder Phase 4
Completed NCT00844922 - Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842) Phase 2
Completed NCT00455234 - Rapid Tranquillization Trial: TREC-India II Phase 3
Completed NCT00226278 - Safety Study of ORG 34517 for Major Depression With Psychotic Features Phase 2