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

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.

Study Overview

• Status: Completed
• Conditions: Psychiatric Rehabilitation
• Intervention / Treatment: Combination product: Biological,Psychological and Social support

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 Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• Denmark
  • Region Zealand
    • Slagelse, Region Zealand, Denmark, 4200
      • Psykiatrisk Forskningsenhed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• all patients able and willing to participate

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: Psychiatric Research Unit, Region Zealand, Denmark
• Investigators: Study Director: Erik Simonsen, Professor, Psykiatrisk Forskningsenhed

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): November 30, 2017
• Study Completion (ACTUAL): November 30, 2017

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: UFL-03-18-0170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes