Investigation of Change in The WHO-5 Well-Being Index During a Year in a Community Psychiatry in Denmark

NCT03501329 | Completed FDA Drug

• 1 other identifier: UFL-03-18-0170
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychiatric Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

Study Arms (1)

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.

Combination Product: Biological,Psychological and Social support

Interventions

Biological,Psychological and Social support COMBINATION_PRODUCT

Outpatients in Community Psychiatry

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The 752 patients registered as receiving service in district psychiatry during 2017

You may qualify if:

• all patients able and willing to participate

You may not qualify if:

• patients with mental conditions making them unable to answer simple questions about their daily life (in general severe psychosis and severe organic mental disorders)

Sponsors & Collaborators

• Psychiatric Research Unit, Region Zealand, Denmark: lead

Study Sites (1)

Psykiatrisk Forskningsenhed

Slagelse, Region Sjælland, 4200, Denmark

Location

Related Publications (1)

• 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.

  PMID: 25831962 RESULT

MeSH Terms

Interventions

Biological Products

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• Erik Simonsen, Professor

  Psykiatrisk Forskningsenhed

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (in this area of research)

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 18, 2018
• Study Start: January 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-04

Locations

DK (1)