Condition category
Mental and Behavioural Disorders
Date applied
30/09/2019
Date assigned
30/10/2019
Last edited
30/10/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Peer support is an established intervention involving a person in recovery from mental illness being engaged to offering support to others with mental illness. There are significant gaps in the evidence base for peer support in low-/middle-income and in non-Anglophone countries. Building upon comprehensive formative research, UPSIDES-RCT will explore the implementation and effectiveness of peer support delivered in a range of high-, middle- and low-income country contexts. Main objectives are: (1) To evaluate the outcomes of delivering peer support, for service users, peer support workers and organisations, through a multi-centre pragmatic parallel-group randomised controlled trial and additional qualitative methods. (2) To assess the value for money of peer support for persons with severe mental illness, by carrying out a cost-effectiveness study. (3) To evaluate the process of implementing the UPSIDES peer support intervention, with special attention to differences in context across the study sites, using both quantitative and qualitative methods with peer support workers, service users, mental health workers and wider stakeholders

Who can participate?
Adults (18 -60 years) with mental illness

What does the study involve?
Participation in UPSIDES-RCT means that participants will meet with an UPSIDES research worker four times over one year (every four months) to give him/her general information about themselves (e.g. age, gender, family situation, work) and about their mental health problems. These interviews will last for about 1 1/2 hours each. This is a randomised controlled trial which means that, if they consent to participation, participants will be allocated per chance (50:50) to the intervention or control group. If they are allocated to the intervention group, they will receive UPSIDES peer support. This service will be provided by a trained UPSIDES peer support worker who has also experienced mental ill health and will support their recovery. If they are allocated to the control group, their participation will involve data as-sessment as described above. As this is a waiting list design, control group participants will receive the intervention in one year

What are the possible benefits and risks of participating?
Participants will be asked questions on their health and mental health during our four meetings in one year. Four meetings will require their time as per interview schedule. This could potentially place a burden on participants. If they are allocated to the intervention group, participants will receive the intervention immediately. If they are in the control group, they will receive the intervention in one year. See participant information sheet at https://www.upsides.org/wp-content/uploads/UPSIDES-RCT-informed-consent-forms.pdf for further information

Where is the study run from?
Ulm University, Germany

When is the study starting and how long is it expected to run for?
January 2020 to December 2021

Who is funding the study?
1. European Union Horizon 2020
2. Indian Council for Medical Research

Who is the main contact?
Prof. Bernd Puschner,
bernd.puschner@bkh-guenzburg.de

Trial website

http://www.upsides.org

Contact information

Type

Public

Primary contact

Prof Bernd Puschner

ORCID ID

http://orcid.org/0000-0002-2929-4271

Contact details

Ulm University
Department of Psychiatry II
Section Process-Outcome-Research
Reisensburger Str. 32
Günzburg
89312
Germany
+49 8221 962866
bernd.puschner@bkh-guenzburg.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Peer support for people with severe mental illness versus usual care: a pragmatic multicentre randomised controlled trial

Acronym

UPSIDES-RCT

Study hypothesis

The aim of UPSIDES-RCT is to explore the implementation and effectiveness of peer support delivered in a range of high-, middle- and low-income country contexts. The main objectives are:
1. To evaluate the outcomes of delivering peer support, for service users, peer support workers and organisations, through a multi-centre pragmatic parallel-group randomised controlled trial (UPSIDES-RCT) and additional qualitative methods.
2. To assess the value for money of peer support for persons with severe mental illness, by carrying out a cost-effectiveness study.
3. To evaluate the process of implementing the UPSIDES peer support intervention, with special attention to differences in context across the study sites, using both quantitative and qualitative methods with PSWs, service users, mental health workers and wider stakeholders.

Ethics approval

1. Approved 21/08/2019, Ulm University Ethics Commission (Room 1.03, Helmholtzstraße 20 [Oberer Eselsberg], 89081 Ulm, Germany; +49 (0) 731 500-22050; ethik-commission@uni-ulm.de), ref: 254/19
2. Approved 02/03/2018, Indian Law Society (ILS Law College Campus, Chiplunkar Road, Pune - 411 004, India; +91 (0)20-25656780; deepapaturkar@ilslaw.in), ref: ILS/37/2018
3. Approved 01/09/2019, Human Subjects Research Committee of Ben-Gurion University (P.O.B 653, Beer Sheva 84105, Israel; +972 (0)86461932; hsrCommittee@bgu.ac.il), ref: 1787-1
4. Approved 21/05/2019, Uganda National Council for Science and Technology (UNCST) (Plot 6 Kimera Rd, Kampala, Uganda; +256 41 4705500; info@uncst.co.ug), ref: SS 4990
5. Approval pending from Tanzania ethics committee

Study design

Pragmatic parallel-group multi-centre randomised controlled trial with four measurement points over one year (baseline, 4-, 8-, and 12-month follow-up), and embedded process evaluation and cost-effectiveness analysis

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

https://www.upsides.org/wp-content/uploads/UPSIDES-RCT-informed-consent-forms.pdf

Condition

Severe mental illness

Intervention

This is a pragmatic parallel-group multi-centre randomised controlled trial with four measurement points over one year (baseline, 4-, 8-, and 12-month follow-up), and embedded process evaluation and cost-effectiveness analysis.

All participants will receive treatment as usual as provided at the respective study site. Participants allocated to the intervention group will additionally receive the UPSIDES peer support, which is a direct service that is delivered by a person who has personal experience of mental health problems to a person or a group of persons with a serious mental illness. UPSIDES peer support workers will be using these personal experiences, along with UPSIDES training and supervision, to facilitate, guide, and mentor another person’s recovery journey. UPSIDES peer support will be delivered for up to six months, with a minimum of three contacts. Weekly or biweekly meetings are recommended, but frequency may vary. The intervention has been developed by all UPSIDES partners, and will be delivered in line with the UPSIDES peer support intervention manual.
Participants will be randomly assigned to either control or intervention group with a 1:1 allocation as per a computer-generated randomisation schedule stratified by site using permuted blocks of random sizes.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Social inclusion at t2 (8 months) measured with the Social Inclusion Scale (SIS)

Secondary outcome measures

Measured at baseline, 4-, 8-, and 12-month follow-up:
1. Empowerment (Empowerment Scale, ES)
2. Hope (HOPE scale)
3. Recovery (Stages of Recovery, STORI-30)
4. Health and social functioning (Health of the Nations Outcome Scales, HoNOS)

Overall trial start date

06/03/2017

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult age (18-60 years) at intake
2. Mental disorder of any kind as main diagnosis established by case notes, staff communication or self-label
3. Presence of severe mental illness (Threshold Assessment Grid ≥ 5 points and illness duration ≥ 2 years)
4. Sufficient command of the host country’s language
5. Capable of giving informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

N= 558; N = 93 per site

Participant exclusion criteria

1. Main diagnosis of learning disability, dementia, substance disorder or organic brain disorder
2. Cognitive impairment severe enough to make it impossible to give informed consent or complete study measures

Recruitment start date

01/01/2020

Recruitment end date

31/12/2020

Locations

Countries of recruitment

Germany, India, Israel, Tanzania, Uganda

Trial participating centre

Ulm University Department of Psychiatry II
Reisensburger Str. 32
Günzburg
89312
Germany

Trial participating centre

University Medical Centre Hamburg- Eppendorf Department of Psychiatry
Martinistraße 52
Hamburg
20246
Germany

Trial participating centre

Butabika National Referral Hospital
Butabika Road
Kampala
P.O. Box 7017
Uganda

Trial participating centre

Ifakara Health Institute
Plot 463, Kiko Avenue Mikocheni
Dar es Salaam
P.O. Box 78 373
Tanzania

Trial participating centre

Ben Gurion University of the Negev, The Charlotte B. and Jack J. Spitzer Department of Social Work
Yitzhack I. Rager Blvd
Beer Sheva
84105
Israel

Trial participating centre

Centre for Mental Health Law and Policy, Indian Law Society
Law College Road
Pune
411004
India

Sponsor information

Organisation

Ulm University, Department of Psychiatry II

Sponsor details

Ludwig-Heilmeyer-Str. 2
Günzburg
89312
Germany
+49 8221 962866
bernd.puschner@bkh-guenzburg.de

Sponsor type

University/education

Website

https://www.uniklinik-ulm.de/psychiatrie-und-psychotherapie-ii/english-version/section-process-outcome-research.html

Organisation

University Medical Centre Hamburg-Eppendorf, Department of Psychiatry

Sponsor details

Martinistraße 52.
Hamburg
20246
Germany
+49 40-7410-58933
c.mahlke@uke.de

Sponsor type

University/education

Website

https://www.uke.de/kliniken-institute/kliniken/psychiatrie-und-psychotherapie/forschung/ab-partizipation.html

Organisation

Butabika National Referral Hospital

Sponsor details

Butabika Road
Kampala
P.O. Box 7017
Uganda
+256 41 4504376
jnakku2013@gmail.com

Sponsor type

Hospital/treatment centre

Website

https://www.butabikahospital.go.ug/

Organisation

Ifakara Health Institute, Department of Health Systems, Impact Evaluation and Policy

Sponsor details

Mikocheni
Kiko Avenue
Dar es Salaam
P.O. Box 78 373
Tanzania
+255 22 2774756
dshamba@ihi.or.tz

Sponsor type

Research organisation

Website

http://ihi.or.tz/health-systems-impact-evaluation-and-policy/

Organisation

Ben Gurion University of the Negev, The Charlotte B. and Jack J. Spitzer Department of Social Work

Sponsor details

Yitzhack I. Rager Blvd
Beer Sheva
84105
Israel
08-6472322
galia.moran@gmail.com

Sponsor type

University/education

Website

https://in.bgu.ac.il/en/humsos/social/Pages/staff/galia-moran@gmail-com.aspx

Organisation

Centre for Mental Health Law and Policy, Indian Law Society

Sponsor details

Law College Road
Pune
411004
India
020-25656775
jasmine@cmhlp.org

Sponsor type

Research organisation

Website

https://cmhlp.org/

Funders

Funder type

Not defined

Funder name

European Union Horizon 2020

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Indian Council for Medical Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Research results will be disseminated in Open Access, peer-reviewed journals and shared through oral and poster presentations at international conferences. All resources (policy briefs, research summaries, training tools, manuals, etc.) will be uploaded to an online knowledge management platform, to increase exposure and ensure accessibility beyond the life of this project.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository.
- Repository name/weblink: https://oparu.uni-ulm.de/xmlui/.
- Type of data that will be shared: Fully anonymized aggregated participant data.
- When the data will become available and for how long: After the last publication, scheduled for late 2021, for 10 years.
- By what access criteria the data will be shared including with whom: Open access, publicly available.
- For what types of analyses and by what mechanism: Open Data Commons (e.g. ODC-ODbl).
- Whether consent from participants was obtained: Only data of participants who have given informed consent will be collected.
- Comments on data anonymization: Only aggregated answers and limited sociodemographic data will be made open access to ensure anonymization.
- Any ethical or legal restrictions: Data sharing in this study will adhere to regulations of all IRB and Ethics Commissions involved. In addition, other regulations of authorities in countries of the study sites, e.g. with regard to data protection, may apply.
- Any other comments: UPSIDES adheres to the Horizon 2020 Pilot on Open Research Data.

Intention to publish date

01/06/2022

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/10/2019: Trial’s existence confirmed by European Commission