Psychiatric DisorderSIMPAQNCT04443374
The Turkish Version of the Simple Physical Activity Questionnaire (SIMPAQ)
An observational study of Psychiatric Disorder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to assess physical activity level particularly people with mental illnesses. The purpose of this study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its psychometric properties. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychiatric Disorder
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2020to 2 Aug 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: This study will include 80 patients diagnosed with major depression, bipolar disorder, anxiety disorder, schizophrenia, alcohol and substance addiction by the psychiatrists in Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital, University of Health Sciences. The individuals who volunteers and meets the inclusion criteria will be included in the study.
Who may be able to join
- Aged between 18 and 60 years Being a volunteer to participate Being an outpatient or inpatient at the place of the study Being diagnosed with major depression, bipolar disorder, anxiety disorder, schizophrenia, alcohol and substance addiction according to DSM-5 or ICD.
Who cannot join
- Having cognitive impairment Having disabilities in understanding, speaking and reading Turkish Having vision and / or hearing problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul University-Cerrahpaşa
Istanbul, 34500
About this study
Official title: The Reliability and Validity of the Turkish Version of the Simple Physical Activity Questionnaire (SIMPAQ)
The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to assess physical activity level particularly people with mental illnesses. The purpose of this study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its psychometric properties.
Read the detailed description
The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to assess physical activity level particularly people with mental illnesses. The purpose of this study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its psychometric properties. Eighty individuals with mental illnesses (major depression, bipolar disorder, anxiety disorder, schizophrenia, alcohol and substance addiction) will include. For cross-cultural adaptation and validation procedure, developers' manual in the official site will be followed (http://www.simpaq.org/). Within a 5-to-7-day period after the first assessment, the participants completed the Turkish version of the SIMPAQ to evaluate test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The correlations with the Turkish version of the International Physical Activity-Short Form (IPAQ-SF) and Brief Psychiatric Rating Scale (BPRS) and Turkish version of the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Scale-Adult Version (DSM XC) will determine to check the validity.
- Conditions
- Psychiatric Disorder
- Keywords
- physical activity, measurement, assessment, sedentary behaviour, mental illness
- Medical subject headings
- Mental Disorders, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Simple Physical Activity Questionnaire
The SIMPAQ is a reliable and valid tool to assess physical activity in people with mental illness. The 5-item SIMPAQ was designed to capture activity over a representative 24-h period from the previous 7-days. Time spent in bed overnight, time sedentary, including napping, time spent walking, time spent exercising and time engaged in incidental activity are questioned and the sum of them should be approximately 24 h. This structure of the SIMPAQ provides interviewers to understand under or over-reporting. For an estimate of total self-reported moderate-vigorous physical activity (MVPA) time, time spent walking and exercising were combined to provide total MVPA (hours per week).
Measured: Baseline (First assessment)
Secondary outcomes (4)
Simple Physical Activity Questionnaire
The SIMPAQ is a reliable and valid tool to assess physical activity in people with mental illness. The 5-item SIMPAQ was designed to capture activity over a representative 24-h period from the previous 7-days. Time spent in bed overnight, time sedentary, including napping, time spent walking, time spent exercising and time engaged in incidental activity are questioned and the sum of them should be approximately 24 h. This structure of the SIMPAQ provides interviewers to understand under or over-reporting. For an estimate of total self-reported moderate-vigorous physical activity (MVPA) time, time spent walking and exercising were combined to provide total MVPA (hours per week).
Measured: Within a 5-to-7-day period after the first assessment (Second assessment)
International Physical Activity Questionnaire-Short Form
International Physical Activity Questionnaire-Short Form (IPAQ-SF) is a self-report questionnaire that assesses PA in the last 7 days. IPAQ-SF provides information on walking, moderate and vigorous activities and time spent sitting, within a week.
Measured: Baseline (First assessment)
Brief Psychiatric Rating Scale
Brief Psychiatric Rating Scale (BPRS) is a valid 18-item quantitative scale for assessing psychopathology and its severity. Each item is measured on a five-point scale (0 = none to 4 = very severe), with lower scores meaning a lower severity of the symptom.
Measured: Baseline (First assessment)
DSM-5 Level 1 Cross-Cutting Symptom Measure-Adult
DSM-5 Level 1 Cross-Cutting Symptom Measure-Adult (DSM XC) comprises 23 self-rated symptoms that capture 13 mental health domains. Respondents indicate how much (or how often) they have been bothered by each symptom in the prior two weeks using a five-point response scale (none, not at all to severe, nearly every day). A score of 2 or higher in most domains, except substance use (score of 1 or higher) is suggestive of clinically-relevant mental health problems.
Measured: Baseline (First assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start30 Jun 2020
- Primary completion30 Jul 2020
- Study completion2 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybike Senel, Istanbul University - Cerrahpasa
- Investigators
- Ebru KAYA MUTLU, PT, PhD, Study director, İstanbul University-Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443374
- Sponsor's protocol ID
- 24
- Acronym
- SIMPAQ
- Status last verified
- Aug 2020
- First submitted
- 22 Jun 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reliability and Validity of the Turkish Version of the Simple Physical Activity Questionnaire (SIMPAQ)
- ClinicalTrials.gov ID
- NCT04443374
- Acronym / sponsor ID
- SIMPAQ / 24
- Conditions
- Psychiatric Disorder
- Keywords
- physical activity, measurement, assessment, sedentary behaviour, mental illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 2 Aug 2020 (actual)
- First posted
- 23 Jun 2020 (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.
The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to assess physical activity level particularly people with mental illnesses. The purpose of this study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its psychometric properties.
Detailed description
The Simple Physical Activity Questionnaire (SIMPAQ) was originally developed in English to assess physical activity level particularly people with mental illnesses. The purpose of this study was to translate and cross-culturally adapt the SIMPAQ into Turkish and investigate its psychometric properties. Eighty individuals with mental illnesses (major depression, bipolar disorder, anxiety disorder, schizophrenia, alcohol and substance addiction) will include. For cross-cultural adaptation and validation procedure, developers' manual in the official site will be followed (http://www.simpaq.org/). Within a 5-to-7-day period after the first assessment, the participants completed the Turkish version of the SIMPAQ to evaluate test-retest reliability. Cronbach's alpha (α) was used to assess internal consistency. The correlations with the Turkish version of the International Physical Activity-Short Form (IPAQ-SF) and Brief Psychiatric Rating Scale (BPRS) and Turkish version of the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Scale-Adult Version (DSM XC) will determine to check the validity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will include 80 patients diagnosed with major depression, bipolar disorder, anxiety disorder, schizophrenia, alcohol and substance addiction by the psychiatrists in Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital, University of Health Sciences. The individuals who volunteers and meets the inclusion criteria will be included in the study.
Key inclusion criteria (1 listed)
- Aged between 18 and 60 years Being a volunteer to participate Being an outpatient or inpatient at the place of the study Being diagnosed with major depression, bipolar disorder, anxiety disorder, schizophrenia, alcohol and substance addiction according to DSM-5 or ICD.
Key exclusion criteria (1 listed)
- Having cognitive impairment Having disabilities in understanding, speaking and reading Turkish Having vision and / or hearing problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Simple Physical Activity Questionnaire
Time frame: Baseline (First assessment)
The SIMPAQ is a reliable and valid tool to assess physical activity in people with mental illness. The 5-item SIMPAQ was designed to capture activity over a representative 24-h period from the previous 7-days. Time spent in bed overnight, time sedentary, including napping, time spent walking, time spent exercising and time engaged in incidental activity are questioned and the sum of them should be approximately 24 h. This structure of the SIMPAQ provides interviewers to understand under or over-reporting. For an estimate of total self-reported moderate-vigorous physical activity (MVPA) time, time spent walking and exercising were combined to provide total MVPA (hours per week).
4 secondary outcomes
Simple Physical Activity Questionnaire
Time frame: Within a 5-to-7-day period after the first assessment (Second assessment)
International Physical Activity Questionnaire-Short Form
Time frame: Baseline (First assessment)
Brief Psychiatric Rating Scale
Time frame: Baseline (First assessment)
DSM-5 Level 1 Cross-Cutting Symptom Measure-Adult
Time frame: Baseline (First assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
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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.
Ebru KAYA MUTLU, PT, PhD study director
İstanbul University-Cerrahpaşa
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 Psychiatric Disorder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 24 Aug 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simple Physical Activity Questionnaire (time frame: Baseline (First assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2020.