Bipolar Disorder, RecoveryNCT05679804
Turkish Validity and Reliability Study of The Bipolar Recovery Questionnaire
An observational study of Bipolar Disorder, Recovery, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In addition to objective criteria (no episode period for 6 months) for defining and monitoring recovery, evaluation of subjective criteria is also very important. Various Turkish scales related to recovery in progressive diseases have been developed or validity-reliability studies have been conducted. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Recovery
- What is being tested?
- validity and realibility of scale
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Dec 2022to 13 May 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bipolar Affective Disorder
Who may be able to join
- Being between 18-65 ages
- Be diagnosed with bipolar affective disorder
- Be at least primary school graduate
Who cannot join
- having a physical disability (blindness, etc.) that might prevent filling in the scales,
- having an additional neurological disease that prevented filling out the scale items.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bilecik Seyh Edebali University Faculty of Medicine
Bilecik, 11000
About this study
In addition to objective criteria (no episode period for 6 months) for defining and monitoring recovery, evaluation of subjective criteria is also very important. Various Turkish scales related to recovery in progressive diseases have been developed or validity-reliability studies have been conducted. However, as far as we know, there is no scale that evaluates subjective improvement for a disorder such as bipolar disorder that progresses in episodes and has a heterogeneous appearance of loss of functionality. In this study, we aimed to conduct a validity and reliability study of the recovery questionnaire for BDD.
- Conditions
- Bipolar Disorder, Recovery
- Being tested
- validity and realibility of scale
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
validity and realibility of scaleOther
Turkish validity and realibility of Bipolar Recovery Questionnare
What is being measured
The primary outcome is the main question the study is designed to answer.
validity and reability of scale
turkish validity and reability of Bipolar Recovery Questionnare
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start13 Dec 2022
- Primary completion13 Apr 2023 (estimated)
- Study completion13 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder, RecoveryStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra GÜNAY YAĞCI, Bilecik Seyh Edebali Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679804
- Sponsor's protocol ID
- BilecikSeyhEU
- Status last verified
- Dec 2022
- First submitted
- 24 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Validity and Reliability Study of The Bipolar Recovery Questionnaire
- ClinicalTrials.gov ID
- NCT05679804
- Acronym / sponsor ID
- BilecikSeyhEU
- Conditions
- Bipolar Disorder, Recovery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 13 Apr 2023 (estimated)
- Study completion
- 13 May 2023 (estimated)
- First posted
- 11 Jan 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.
In addition to objective criteria (no episode period for 6 months) for defining and monitoring recovery, evaluation of subjective criteria is also very important. Various Turkish scales related to recovery in progressive diseases have been developed or validity-reliability studies have been conducted. However, as far as we know, there is no scale that evaluates subjective improvement for a disorder such as bipolar disorder that progresses in episodes and has a heterogeneous appearance of loss of functionality. In this study, we aimed to conduct a validity and reliability study of the recovery questionnaire for BDD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bipolar Affective Disorder
Key inclusion criteria (3 listed)
- Being between 18-65 ages
- Be diagnosed with bipolar affective disorder
- Be at least primary school graduate
Key exclusion criteria (2 listed)
- having a physical disability (blindness, etc.) that might prevent filling in the scales,
- having an additional neurological disease that prevented filling out the scale items.
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 |
|---|---|---|
| validity and realibility of scaleTurkish validity and realibility of Bipolar Recovery Questionnare | Other | – |
Primary outcome
validity and reability of scale
Time frame: 5 months
turkish validity and reability of Bipolar Recovery Questionnare
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bipolar Disorder, Recovery, run by Bilecik Seyh Edebali Universitesi 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 3 inclusion and 2 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 11 Jan 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 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?
Results are not available in the source record.
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?
validity and reability of scale (time frame: 5 months). 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 11 Jan 2023.