Psychiatric Hospitalization Clinical Trial
— RENEW-SOfficial title:
Networked-Based Recovery With User Involvement for Young People With Mental Illness: A Nonrandomized Clinical Trial
Verified date | March 2023 |
Source | Psychiatric Research Unit, Region Zealand, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction Over the past 20 years there has been an overall deterioration in the mental health of young people. An increasing number of young people are diagnosed with emotional disorders such as anxiety and depression. Overall, mental health problems represent the greatest health burden among adolescents. This means that many young people have difficulties in meeting demands, and challenges in education and employment. Thus, it is estimated that up to 60% dropout in education is due to mental health problems. Therefore, an educational, well-coordinated and early intervention is needed to support the young person's recovery process by activating the young person's social network. Methods Study design The project is designed as a non-randomized intervention study with a control group. Comparative analyzes will be performed with pre- and post-assessments, as outlined in Figure 1. The study involves a regional hospital in mental health and five municipalities. The trial takes place from January 2020 to December 2022. Intervention The RENEW-S intervention consists of two key elements: collaborative networking and a youth group that will form the basis of real user involvement. Study population The participants are young adults aged 18 - 30 years with experiences as an inpatient. Procedure for recruitment Questionnaires administered to the patients within the first 48 hours after admission, at discharge, 1 month after discharge and 3 months after discharge (Figure 1). Patients who did not consent to participation or failed to complete the questionnaire at the beginning of their stay were excluded from the study, as were those hospitalized for less than a week. Ethics Information of participants and data management is in accordance with the Helsinki Declaration. The project is reported to the Danish Data Protection Agency and the Region Zealand Ethics Committee. Data are entered into the EasyTrial © Online Clinical Trial Management system. All personal identifiers will be removed or disguised during analysis to preclude personal identification.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 1, 2023 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: - Young adults aged 18 - 30 years - Diagnosed with a mental disorder - Have experienced hospitalization Exclusion Criteria: - Cognitive deficit - Patients who did not consent to participation - Hospitalized for less than a week |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Psychiatric Research Unit, Region Zealand, Denmark |
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mental health status. | Mental health status is valid and reliable indicator of the patients self-reported mentale state and well-being. Mental status is assessed using the standardized Short Form Health Survey (SF-36). Scores range from 0 (zero) to 100, with higher scores indicating better health. | At baseline and after 4 months. | |
Secondary | Change in Level of function. | The young adults' level of function is assessed using the Global assessment of functioning (GAF). Scores range from 0 to 100, with higher scores indicating better health. | At baseline and after 4 months. | |
Secondary | Change in Patient satisfaction. | Satisfaction is measured with the client satisfaction score scale (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater satisfaction. | At baseline and after 4 months. | |
Secondary | Change in Recovery. | The patients' recovery will be assessed by the 24-item recovery assessment scale-revised (RAS-R). Score range of 46-120, with higher scores indicating a higher degree of recovery. | At baseline and after 4 months. |
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