Psychotic DisordersNCT05869409
Physical Activity, Psychopathology, and Quality of Life in People With Psychotic or Affective Disorders
An observational study of Psychotic Disorders and Affective Disorder, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders, Affective Disorder
- What is being tested?
- Physical activity and sedentary behavior education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2022to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- a diagnosis of a psychotic disorder or affective disorder
Who cannot join
- major cognitive deficits, indicated by total scores > 8 points, obtained with the Montreal Cognitive Assessment (MoCA) Scale at baseline
Trial locations and contacts
1 site in 1 country.
Ernest Swora, MA contact
Poland1 site, 1 recruiting
- Recruiting
SWPS University, Faculty of Psychology in Wroclaw
Wroclaw, Lower Silezia, 53-238
Tomasz Grzyb, PhD, +4871 750 72 97, tgrzyb@swps.edu.pl
Anna Banik, PhD, abanik@swps.edu.pl
About this study
Official title: The Relationships Between Physical Activity, Psychopathological Symptoms, and Health-Related Quality of Life in People Diagnosed With Psychotic or Affective Disorders
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
- Being tested
- Physical activity and sedentary behavior education
- Keywords
- Physical Activity, Quality of Life
- Medical subject headings
- Psychotic Disorders, Mood Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity and sedentary behavior educationBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| People diagnosed with a psychotic disorder or an affective disorder | Not described Receives: Behavioral: Physical activity and sedentary behavior education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from the baseline health-related quality of life at 6 weeks
Secondary outcomes (5)
Positive Symptoms (Psychosis)
scores obtained with Positive and Negative Syndrome Scales (PANSS): Positive Symptoms subscale, scores range: 7-49; higher scores indicate more symptoms
Measured: change from the baseline positive symptoms at 6 weeks
Negative Symptoms (Psychosis)
scores obtained with Positive and Negative Syndrome Scales (PANSS): Negative Symptoms subcale, scores range: 7-49, higher scores indicate more symptoms
Measured: change from the baseline negative symptoms at 6 weeks
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
Measured: change from the baseline general psychopathology symptoms at 6 weeks
Depression symptoms
scores obtained in Patient Health Questionnaire -9 (PHQ-9); scores range: 0-36; higher scores indicate more severe symptoms of depression
Measured: change from baseline depression symptoms at 6 weeks
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
Measured: change from baseline physical activity at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 May 2022
- Primary completion1 May 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Social Sciences and Humanities, Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869409
- Sponsor's protocol ID
- SWPS_01/P/01/2020
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be made open and deposited at Open Science Framework repository. Anonymized data will include aggregated (sum) scores for all outcome measures.
Publications
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.
PubMed 9626712Levis 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.
PubMed 30967483Kay 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.
PubMed 3616518Lee 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.
PubMed 22018588
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationships Between Physical Activity, Psychopathological Symptoms, and Health-Related Quality of Life in People Diagnosed With Psychotic or Affective Disorders
- ClinicalTrials.gov ID
- NCT05869409
- Acronym / sponsor ID
- SWPS_01/P/01/2020
- Conditions
- Psychotic Disorders, Affective Disorder
- Keywords
- Physical Activity, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Social Sciences and Humanities, WarsawUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People diagnosed with a psychotic disorder or an affective disorder | – | Behavioral: Physical activity and sedentary behavior education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- a diagnosis of a psychotic disorder or affective disorder
Key exclusion criteria (1 listed)
- major cognitive deficits, indicated by total scores > 8 points, obtained with the Montreal Cognitive Assessment (MoCA) Scale at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity and sedentary behavior educationEnrolled 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). | Behavioural | People diagnosed with a psychotic disorder or an affective disorder |
Primary outcome
Health-Related Quality of Life
Time frame: 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
5 secondary outcomes
Positive Symptoms (Psychosis)
Time frame: change from the baseline positive symptoms at 6 weeks
Negative Symptoms (Psychosis)
Time frame: change from the baseline negative symptoms at 6 weeks
General Psychopathology Symptoms )Psychosis)
Time frame: change from the baseline general psychopathology symptoms at 6 weeks
Depression symptoms
Time frame: change from baseline depression symptoms at 6 weeks
Physical activity
Time frame: change from baseline physical activity at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Background: PubMed 9626712Development 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.
- Background: PubMed 30967483Levis 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.
- Background: PubMed 3616518Kay 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.
- Background: PubMed 22018588Lee 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.
- Individual participant dataSharing planned: Yes. Anonymized data will be made open and deposited at Open Science Framework repository. Anonymized data will include aggregated (sum) scores for all outcome measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest Swora, MA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychotic Disorders and Affective Disorder, run by University of Social Sciences and Humanities, Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Luszczynska, PhD (0048604576066, aluszczynska@swps.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (time frame: change from the baseline health-related quality of life at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05869409, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.