Psychiatric RehabilitationNCT03501329
Investigation of Change in The WHO-5 Well-Being Index During a Year in a Community Psychiatry in Denmark
An observational study of Psychiatric Rehabilitation, run by Psychiatric Research Unit, Region Zealand, Denmark at 1 site in Denmark.
Trial summary
Patient reported quality of life was measured using the WHO-5 Well-Being Index in a group of outpatients in the Community Psychiatry in Holbaek, Denmark. Methods The first and last answer were compared and significance of change in various subgroups of patients was estimated using the PSPP statistical program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Psychiatric Rehabilitation
- What is being tested?
- Biological,Psychological and Social support
- How many people
- 204 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2017to 30 Nov 2017
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The 752 patients registered as receiving service in district psychiatry during 2017
Who may be able to join
- all patients able and willing to participate
Who cannot join
- patients with mental conditions making them unable to answer simple questions about their daily life (in general severe psychosis and severe organic mental disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Patient reported quality of life was measured using the WHO-5 Well-Being Index in a group of outpatients in the Community Psychiatry in Holbaek, Denmark.
Methods
The first and last answer were compared and significance of change in various subgroups of patients was estimated using the PSPP statistical program.
Read the detailed description
Investigation of the change of The WHO-5 Wellbeing Index during a year in a Community Psychiatry in Denmark.
Introduction
In the Community Psychiatry of the town Holbaek part of Region West of The Region Sjaelland in eastern Denmark the WHO-5 Well-Being Index has for 5 years been used in order to obtain the patients personal evaluation of their actual quality of life. That has given the possibility of following changes during the treatment. The questionnaire is easy to understand and to use as part of a consultation. The patients will answer the 5 questions in a few minutes. The WHO-5 questionnaire is thoroughly evaluated internationally and described and used in many clinical situations also outside of psychiatry and fulfill measures of psychometric quality. With this work the intention was to try to answer often critical questions from our administration and from the press and in the society. There was no funding for the work.
- Conditions
- Psychiatric Rehabilitation
- Being tested
- Biological,Psychological and Social support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological,Psychological and Social supportCombination product
| Study group | Role | What they receive |
|---|---|---|
| Outpatients in Community Psychiatry | Treatment with consultations, social support, psychological and psychopharmacological treatment. This is routine psychiatric care.
Treatment was not changed as a result of the investigation in itself. Receives: Combination Product: Biological,Psychological and Social support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The WHO-5 Well-Being Index
This is a Patient Reported Outcome Measure (PROM) for studying changes in the Well-Being Index during ongoing treatment. In many cases it was not possible to maintain the patients in the study for the intended time period and it was found necessary to accept the latest evaluation as the final measurement of change. It will be possible to report the observation time in months for each single case and to report the median of these periods of observation.
Measured: The Time Frame was from the beginning of the participation in the study (baseline) and at the completion of the study participation (approximately 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Jan 2017
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychiatric RehabilitationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Folker, Psychiatric Research Unit, Region Zealand, Denmark
- Investigators
- Erik Simonsen, Professor, Study director, Psykiatrisk Forskningsenhed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501329
- Sponsor's protocol ID
- UFL-03-18-0170
- Status last verified
- Apr 2018
- First submitted
- 21 Mar 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
PubMed 25831962
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Change in The WHO-5 Well-Being Index During a Year in a Community Psychiatry in Denmark
- ClinicalTrials.gov ID
- NCT03501329
- Acronym / sponsor ID
- UFL-03-18-0170
- Conditions
- Psychiatric Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Psychiatric Research Unit, Region Zealand, DenmarkUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 18 Apr 2018 (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.
Patient reported quality of life was measured using the WHO-5 Well-Being Index in a group of outpatients in the Community Psychiatry in Holbaek, Denmark.
Methods
The first and last answer were compared and significance of change in various subgroups of patients was estimated using the PSPP statistical program.
Detailed description
Investigation of the change of The WHO-5 Wellbeing Index during a year in a Community Psychiatry in Denmark.
Introduction
In the Community Psychiatry of the town Holbaek part of Region West of The Region Sjaelland in eastern Denmark the WHO-5 Well-Being Index has for 5 years been used in order to obtain the patients personal evaluation of their actual quality of life. That has given the possibility of following changes during the treatment. The questionnaire is easy to understand and to use as part of a consultation. The patients will answer the 5 questions in a few minutes. The WHO-5 questionnaire is thoroughly evaluated internationally and described and used in many clinical situations also outside of psychiatry and fulfill measures of psychometric quality. With this work the intention was to try to answer often critical questions from our administration and from the press and in the society. There was no funding for the work.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients in Community Psychiatry | – | Combination Product: Biological,Psychological and Social supportTreatment with consultations, social support, psychological and psychopharmacological treatment. This is routine psychiatric care. Treatment was not changed as a result of the investigation in itself. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The 752 patients registered as receiving service in district psychiatry during 2017
Key inclusion criteria (1 listed)
- all patients able and willing to participate
Key exclusion criteria (1 listed)
- patients with mental conditions making them unable to answer simple questions about their daily life (in general severe psychosis and severe organic mental disorders)
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 |
|---|---|---|
| Biological,Psychological and Social support | Combination product | Outpatients in Community Psychiatry |
Primary outcome
Change in The WHO-5 Well-Being Index
Time frame: The Time Frame was from the beginning of the participation in the study (baseline) and at the completion of the study participation (approximately 1 year).
This is a Patient Reported Outcome Measure (PROM) for studying changes in the Well-Being Index during ongoing treatment. In many cases it was not possible to maintain the patients in the study for the intended time period and it was found necessary to accept the latest evaluation as the final measurement of change. It will be possible to report the observation time in months for each single case and to report the median of these periods of observation.
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 18 Apr 2018.
- Results publication: PubMed 25831962Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.
- Individual participant dataSharing planned: Undecided
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.
Erik Simonsen, Professor study director
Psykiatrisk Forskningsenhed
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 Rehabilitation, run by Psychiatric Research Unit, Region Zealand, Denmark at 1 site in Denmark.
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 18 Apr 2018. 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 Denmark. 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?
Change in The WHO-5 Well-Being Index (time frame: The Time Frame was from the beginning of the participation in the study (baseline) and at the completion of the study participation (approximately 1 year).). 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 NCT03501329, which also lists 1 linked publication.
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 18 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.