Investigating the Meaning and (Cost-)Effectiveness of Dutch Recovery Colleges

Severe Mental Illness Clinical Trial

Official title:

Investigating the Meaning and (Cost-)Effectiveness of Dutch Recovery Colleges

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05620212
• Other study ID #: TSB_RP390
• Status: Active, not recruiting
• Start date: March 17, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Tilburg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Recovery colleges (RC) aim to promote the recovery of people who experience mental vulnerabilities. Rather than facilitating treatment of illness (as regular mental health care services [MHCS] do), RCs are learning environments, with a special focus on peer support and co-creation. While MHCS are founded on scientific and professional knowledge, RCs value the knowledge and abilities of those with lived experiences as such. By sharing experiences, RC attendees can inspire and support each other (hence 'peer support') and they can use their experiences to contribute to the educational program (hence 'co-creation'). In the Netherlands RCs are 100% peer run, meaning that no mental health care workers are involved.

Despite promising premature findings on the effectiveness of RC attendance (e.g., positive impacts on MHCS use, mental wellbeing and functioning, quality of life, empowerment and more), large, controlled studies are extremely scarce. Furthermore, the way RCs are managed in the Netherlands seems to differ from the RCs that have been studied before. While RCs in some countries are a coproduction of peers and mental health practitioners, RCs in the Netherlands are 100% peer run, although they are usually hosted by MHCS. In turn, this research project aims to investigate the (cost-)effectiveness of RCs in the Netherlands. In terms of effectiveness, we expect that RC attendance improves feelings of empowerment. Besides, we investigate impacts on quality of life, mental health, loneliness, satisfaction with treatment and support and self-stigma. We also determine the cost-effectiveness of Dutch RCs.

Description:

This quantitative study is part of a larger research project that entails qualitative analysis of:

• the meaning of Enik RC for its partakers (the first RC established in the Netherlands in 2015);

• the position that RCs can and should have in the Dutch MHCS landscape;

• a fidelity measure to define the core elements of Dutch RCs and to obtain an overview of the available initiatives in the Netherlands

The research project is executed in close collaboration with co-researchers who are partakers of Enik RC. The findings of the pre-registered quantitative study will be evaluated and contextualized in co-creation as such.

NOTE: The Observational Study Model is both Cohort (monitoring for a period of 2 years) and Case-Control (comparing RC partakers with non-partakers).

NOTE: Enik Recovery College has 7 established locations in the region of Utrecht at the time of our recruitment. All are included.

NOTE: Fameus has 4 established locations (Breda 2x, Tilburg, Roosendaal). All are included.

NOTE: This study is conducted both by Tilburg University (Department Tranzo) and Trimbos-institute (Department of Reintegration and Community Care) as primary organizations. The PI is also affiliated with both.

NOTE. The aimed sample size at t0 is N=120 in the RC condition. So 120 partakers of RCs will be matched with members from the PPG.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 142
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For RC group: needs to attend one of the four participating RCs regularly, at least more than once.

• Needs to experience severe mental illness/psychological vulnerabilities (both self-reported or officially diagnosed).

• Needs to master the Dutch language to sufficient extent to understand the surveys.

• Is 18 years or older.

Exclusion Criteria:

• For the RC group: does not attend one of the four participating RCs regularly.

• Does not experience severe mental illness/psychological vulnerabilities.

• Does not master the Dutch language to a sufficient extent.

• Is younger than 18 years old.

• For the control group (PPG): attends an RC regularly, but not one of the four participating RCs. If an existing PPG member attends one of the four participating RCs regularly, they are allocated to the RC group.

Related Conditions & MeSH terms

• Mental Disorders
• Severe Mental Illness

Intervention

Behavioral:
• Recovery College participation
Recovery College participation in any way (visitors, course/retreat participants, volunteers, employees).

Locations

Country	Name	City	State
Netherlands	Korak	Apeldoorn
Netherlands	Herstelacademie Haarlem en Meer	Haarlem
Netherlands	Fameus	Tilburg
Netherlands	Enik Recovery College	Utrecht

Sponsors (5)

Lead Sponsor	Collaborator
Tilburg University	Gemeente Utrecht, Lister, Stichting tot steun VCVGZ, Trimbos-institute (also primary organization conducting the study)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change Health Care and Services Use (cost-effectiveness)	Use of health care facilities (e.g., GP, mental health care facilities, psychiatric hospital), services use (e.g., municipality services) and medication, to be transformed into economic costs by the use of the iMTA costing tool.; Source: Kanters TA, Bouwmans CAM, Van der Linden N, Tan SS, Hakkaart-van Roijen L. Update of the Dutch manual for costing studies in health care. Plos One.	t0 = baseline, t1= 0.5 year later, t2 = 1 year later, t3 = 1.5 years later, t4 = 2 years later.
Other	Change in Health Status (cost-effectiveness)	Operationalized by means of the EQ-5D. Source: Rabin, R., & Charro, F. D. (2001). EQ-SD: a measure of health status from the EuroQol Group. Annals of medicine, 33(5), 337-343. https://doi.org/10.3109/07853890109002087	t0 = baseline, t1= 0.5 year later, t2 = 1 year later, t3 = 1.5 years later, t4 = 2 years later.
Other	Change in Employment Status (cost-effectiveness)	Whether or not the participant has paid employment or a volunteering job.	t0 = baseline, t1= 0.5 year later, t2 = 1 year later, t3 = 1.5 years later, t4 = 2 years later.
Other	Change in Absenteeism and Presenteeism (cost-effectiveness)	The amount of working days participants were ill and could not work (absenteeism), and the amount of working days participants were ill but still went to work (presenteeism). Regarding presenteeism we inquire about the % of work done as compared to an average working day. This will be transformed into costs.	t0 = baseline, t1= 0.5 year later, t2 = 1 year later, t3 = 1.5 years later, t4 = 2 years later.
Other	Change in Providing and Receiving Informal Care (cost-effectiveness)	Questions whether participant provides informal care (and if so, how many hours per week) and whether participant receives informal care from e.g., family or friends (and if so, how many hours per week). This will be transformed into costs.	t0 = baseline, t1= 0.5 year later, t2 = 1 year later, t3 = 1.5 years later, t4 = 2 years later.
Primary	Change in Empowerment	Operationalized by means of four subscales (Confidence and Purpose, Connectedness, Self-management and Professional help) of the Netherlands Empowerment List.; Source: Boevink, W., Kroon, H., Delespaul, P., & Van Os, J. (2016). Empowerment according to persons with severe mental illness: development of the Netherlands empowerment list and its psychometric properties. Open Journal of Psychiatry, 7(1), 18-30. http://dx.doi.org/10.4236/ojpsych.2017.71002	t0 = baseline, t1= 1 year later, t2 = 2 years later.
Secondary	Change in Quality of Life (effectiveness)	Operationalized by means of the Maastricht QoL Scale. Source: Drukker, M., Bak, M., à Campo, J., Driessen, G., Van Os, J., & Delespaul, P. (2010). The cumulative needs for care monitor: a unique monitoring system in the south of the Netherlands. Social psychiatry and psychiatric epidemiology, 45(4), 475-485. https://link.springer.com/content/pdf/10.1007/s00127-009-0088-3.pdf	t0 = baseline, t1= 1 year later, t2 = 2 years later.
Secondary	Change in Mental Health (effectiveness)	Operationalized by means of the MHI-5 scale. Source: Rumpf, H. J., Meyer, C., Hapke, U., & John, U. (2001). Screening for mental health: validity of the MHI-5 using DSM-IV Axis I psychiatric disorders as gold standard. Psychiatry research, 105(3), 243-253. https://doi.org/10.1016/S0165-1781(01)00329-8	t0 = baseline, t1= 1 year later, t2 = 2 years later.
Secondary	Change in Loneliness (effectiveness)	Operationalized by means of the DeJong Gierveld Loneliness Scale. Source: De Jong-Gierveld, J., & Van Tilburg, T. (1990). Manual of the loneliness scale. Amsterdam, Netherlands: Vrije Universiteit.	t0 = baseline, t1= 1 year later, t2 = 2 years later.
Secondary	Change in Satisfaction with Treatment and Support (effectiveness)	Operationalized by means of an inventory adapted from Nivel. Source: Menting, J. De Zorgmonitor - Nationaal Panel Chronisch zieken en Gehandicapten. Uit: www.nivel.nl [Laatst gewijzigd op 18-03-2021; geraadpleegd op 30-08-2022]. URL: https://www.nivel.nl/nl/nationaal-panel-chronisch-zieken-en-gehandicapten/de-zorgmonitor	t0 = baseline, t1= 1 year later, t2 = 2 years later.
Secondary	Change in Self-stigma (effectiveness)	Operationalized by means of the ISMI-10 scale. Source: Boyd, J. E., Otilingam, P. G., & DeForge, B. R. (2014). Brief version of the Internalized Stigma of Mental Illness (ISMI) scale: Psychometric properties and relationship to depression, self esteem, recovery orientation, empowerment, and perceived devaluation and discrimination. Psychiatric Rehabilitation Journal, 37(1), 17-23. https://doi.org/10.1037/prj0000035	t0 = baseline, t1= 1 year later, t2 = 2 years later.