Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Networked-Based Recovery With User Involvement (RENEW-S)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097977
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Haurum Marcussen, Psychiatric Research Unit, Region Zealand, Denmark

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Psychiatric Hospitalization Other: An educational support model called RENEW (Rehabilitation for Empowerment, Natural Support, Education and Work) targeting young people with mental health difficulties. Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The project is designed as a non-randomized intervention study with a control group.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Networked-Based Recovery With User Involvement for Young People With Mental Illness: A Nonrandomized Clinical Trial
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Intervention: RENEW in a psychiatric ward
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.
Other: An educational support model called RENEW (Rehabilitation for Empowerment, Natural Support, Education and Work) targeting young people with mental health difficulties.

An educational support model called RENEW (Rehabilitation for Empowerment, Natural Support, Education and Work).

Intervention The RENEW-S intervention consists of two key elements: collaborative networking and a youth group.

Network meetings The RENEW-S network meetings is fundamental for this approach. First meeting between the young person and the facilitator is about what the young person can expect, and information about the principles and ideas behind RENEW-S. The RENEW-S process consists of 4 general phases: 1) a mapping process 2) the development of a team to support goal attainment 3) implementing the plans 4) preparation for exiting RENEW.

Youth group The group is structured around the same agenda each time, starting with a presentation round, followed by an activity within the topic of the day, and finishing with sharing experiences of the activity in plenum. The young people can find inspiration regarding themes and exercises in the RENEW manual.


No Intervention: Conventional clinical practice in a psychiatric standard ward
The comparison group patients were admitted to a standard psychiatric ward that offered conventional care.



Primary Outcome Measures :
  1. Change in Mental health status. [ Time Frame: At baseline and after 4 months. ]
    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.


Secondary Outcome Measures :
  1. Change in Level of function. [ Time Frame: At baseline and after 4 months. ]
    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.

  2. Change in Patient satisfacion. [ Time Frame: At baseline and after 4 months. ]
    Satisfaction is measured with the client satisfaction score scale (CSQ-8). Total scores range from 8 to 32, with higher scores indicating greater satisfaction.

  3. Change in Recovery. [ Time Frame: At baseline and after 4 months. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097977


Contacts
Layout table for location contacts
Contact: Michael Marcussen, Dr. +45 26369503 mhmc@regionsjaelland.dk
Contact: Sidse Arnfred, Professor. +45 24227045 sidar@regionsjaelland.dk

Sponsors and Collaborators
Psychiatric Research Unit, Region Zealand, Denmark
Investigators
Layout table for investigator information
Principal Investigator: Michael Marcussen, Dr. University of Southern Denmark, Denmark.

Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: Michael Haurum Marcussen, Principal Investigator, Psychiatric Research Unit, Region Zealand, Denmark
ClinicalTrials.gov Identifier: NCT04097977     History of Changes
Other Study ID Numbers: PRURegionZealand2
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Haurum Marcussen, Psychiatric Research Unit, Region Zealand, Denmark:
User involvement
Patient-reported outcomes
Networked-based recovery