Networked-Based Recovery With User Involvement

NCT04097977 | Withdrawn DMC

• 1 other identifier: PRURegionZealand2
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychiatric Hospitalization

Keywords

User involvement; Patient-reported outcomes; Networked-based recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Level of function.

  At baseline and after 4 months.

• Change in Patient satisfaction.

  At baseline and after 4 months.

• Change in Recovery.

  At baseline and after 4 months.

Study Arms (2)

Intervention: RENEW in a psychiatric ward

EXPERIMENTAL

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.

Conventional clinical practice in a psychiatric standard ward

NO INTERVENTION

The comparison group patients were admitted to a standard psychiatric ward that offered conventional care.

Interventions

An educational support model called RENEW (Rehabilitation for Empowerment, Natural Support, Education and Work) targeting young people with mental health difficulties. OTHER

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.

Intervention: RENEW in a psychiatric ward

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Young adults aged 18 - 30 years
• Diagnosed with a mental disorder
• Have experienced hospitalization

You may not qualify if:

• Cognitive deficit
• Patients who did not consent to participation
• Hospitalized for less than a week

Sponsors & Collaborators

• Psychiatric Research Unit, Region Zealand, Denmark: lead

Related Publications (10)

• McGorry PD. The specialist youth mental health model: strengthening the weakest link in the public mental health system. Med J Aust. 2007 Oct 1;187(S7):S53-6. doi: 10.5694/j.1326-5377.2007.tb01338.x.

  PMID: 17908028 BACKGROUND

• Andreasen J, Poulsen S, Hoej M, Arnfred S. 'It is important for us to see the mentors as persons' - participant experiences of a rehabilitation group. Int J Qual Stud Health Well-being. 2019 Dec;14(1):1632108. doi: 10.1080/17482631.2019.1632108.

  PMID: 31238817 BACKGROUND

• Hunt J, Eisenberg D. Mental health problems and help-seeking behavior among college students. J Adolesc Health. 2010 Jan;46(1):3-10. doi: 10.1016/j.jadohealth.2009.08.008. Epub 2009 Oct 20.

  PMID: 20123251 BACKGROUND

• Waldemar AK, Esbensen BA, Korsbek L, Petersen L, Arnfred S. Recovery-oriented practice: Participant observations of the interactions between patients and health professionals in mental health inpatient settings. Int J Ment Health Nurs. 2019 Feb;28(1):318-329. doi: 10.1111/inm.12537. Epub 2018 Aug 27.

  PMID: 30151987 BACKGROUND

• Buus N, Juel A, Haskelberg H, Frandsen H, Larsen JLS, River J, Andreasson K, Nordentoft M, Davenport T, Erlangsen A. User Involvement in Developing the MYPLAN Mobile Phone Safety Plan App for People in Suicidal Crisis: Case Study. JMIR Ment Health. 2019 Apr 16;6(4):e11965. doi: 10.2196/11965.

  PMID: 30990456 BACKGROUND

• Berring LL, Hummelvoll JK, Pedersen L, Buus N. A Co-operative Inquiry Into Generating, Describing, and Transforming Knowledge About De-escalation Practices in Mental Health Settings. Issues Ment Health Nurs. 2016 Jul;37(7):451-63. doi: 10.3109/01612840.2016.1154628. Epub 2016 Apr 12.

  PMID: 27070499 BACKGROUND

• Hendryx M, Green CA, Perrin NA. Social support, activities, and recovery from serious mental illness: STARS study findings. J Behav Health Serv Res. 2009 Jul;36(3):320-9. doi: 10.1007/s11414-008-9151-1. Epub 2008 Nov 15.

  PMID: 19011972 BACKGROUND

• Richards DA, Bower P, Chew-Graham C, Gask L, Lovell K, Cape J, Pilling S, Araya R, Kessler D, Barkham M, Bland JM, Gilbody S, Green C, Lewis G, Manning C, Kontopantelis E, Hill JJ, Hughes-Morley A, Russell A. Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial. Health Technol Assess. 2016 Feb;20(14):1-192. doi: 10.3310/hta20140.

  PMID: 26910256 BACKGROUND

• Andriessen K. Suicide bereavement and postvention in major suicidology journals: lessons learned for the future of postvention. Crisis. 2014;35(5):338-48. doi: 10.1027/0227-5910/a000269.

  PMID: 25163845 BACKGROUND

• Patel V, Flisher AJ, Hetrick S, McGorry P. Mental health of young people: a global public-health challenge. Lancet. 2007 Apr 14;369(9569):1302-1313. doi: 10.1016/S0140-6736(07)60368-7.

  PMID: 17434406 RESULT

MeSH Terms

Interventions

Rehabilitation; Educational Status

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Michael Marcussen, Dr.

  University of Southern Denmark, Denmark.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The project is designed as a non-randomized intervention study with a control group.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 20, 2019
• Study Start: October 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: January 1, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share