Condition category
Mental and Behavioural Disorders
Date applied
24/01/2017
Date assigned
31/01/2017
Last edited
31/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Psychotic disorders are a group of serious mental health problem that affect how a person thinks, feels and behaves. One of the most common examples of a psychotic disorder is schizophrenia. Psychotic disorders cause a range of symptoms including hallucinations (seeing or hearing things that aren’t there), delusions (beliefs that are not based on reality) and changes in behaviour. These symptoms can lead to problems socialising with others, often leading to loneliness and isolation. Attempts have been made during the last decade to improve skills for social and community functioning in patients with psychotic disorders, but clinic-based social skill training is not necessarily directly transferable to real-life situations. Home-based programs are expected to be more effective, because skills are learned in the same context as needed in daily life. Research showed that home-based skills programs in schizophrenia led to more improvement in social and community functioning than traditional clinic-based ones. However, more research is needed to look at the overall effect of home-based training on patients’ functioning. Peer support groups have been shown to have positive effects on social networks, social support, recovery, empowerment and hope. They involve working with trained “peers” who have gone through a process of recovery, assisting other people with mental health issues. The aim of this study is to look at the effectiveness of a nurse-led program that combines home-based skill training combined with nurse guided peer support.

Who can participate?
Adults who have been diagnosed with schizophrenia and other psychotic disorders.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the nurse-led program. This program is structured around an eating club, providing opportunities to practice skills in the living environment. Over 18 weeks, three patients take it in turns to organise nine dinners at home with support from a nurse. Having dinner together creates a peer support setting and organizing a dinner offers many naturally occurring opportunities to work on social- and community living skills in patients’ personal environment. During the main course of dinner, participants start off by exchanging positive experiences they had during the past two weeks. The group then chooses an illness-related discussion topic during dessert that afterwards is discussed in a twenty-minute session. The nurse concludes each meeting by reinforcing the participants for their efforts and reiterating the next dinner appointment. Each dinner takes approximately two hours. Participants also receive skills training in self-management (e.g. cooking, planning, cleaning) or social skills (e.g. complimenting, assertiveness, listening), which can be delivered on the telephone or face-to-face. Those in the second group are placed on a waiting list and receive the program after the study has finished. At the start of the study and after eight and 12 months, participants in both groups complete a range of questionnaires to assess their mental wellbeing and social functioning.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
1. Lentis Psychiatric Institute (Netherlands)
2. GGZ Drenthe (Netherlands)
3. Dimence (Netherlands)
4. GGZ Friesland (Netherlands)
5. GGZ Noord Holland Noord (Netherlands)

When is the study starting and how long is it expected to run for?
August 2014 to February 2018

Who is funding the study?
National Academy of Sciences (USA)

Who is the main contact?
Dr Musharraf Cyan
cyan@gsu.edu

Trial website

www.hyproject.net

Contact information

Type

Scientific

Primary contact

Mr Jelle Sjoerd Vogel

ORCID ID

http://orcid.org/0000-0003-2890-6173

Contact details

Lentis Psychiatric Institute
Hereweg 80
Groningen
9725 AG
Netherlands
+31 647 327 668
js.vogel@lentis.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2014.479. METC Groningen

Study information

Scientific title

HospitalitY project (HY): Combining peer support and home-based skill training to improve social contact and life skills in patients with schizophrenia; A randomized controlled trial

Acronym

HY

Study hypothesis

The aim of this study is to investigate the effectiveness of an nurse led intervention that combines home-based skill training combined with nurse guided peer support.

Ethics approval

The study does not require ethical approval as decided by the ethical board of the University Medical Centre Groningen (UMCG). This is stated in a letter from the ethical board (reference METc2014.479).

Study design

Multi-centre randomised wait-list controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Schizophrenia and related psychotic disorders

Intervention

Participants are randomized to one of two groups by a list of randomly generated numbers from randomizer.org. The randomization process is conducted by a person not affiliated to the research team. Participants will be randomised in blocks of seven individuals with a ratio 3:4 (intervention:control).

Intervention group: Participants receive the HY intervention. The intervention is structured around an eating club, providing opportunities to practice skills in the living environment. The integrated approach of HY is expected to provide patients with opportunities to learn and practice strategies and skills that are relevant for functional and personal recovery in a supportive environment. We expect social skills to develop when appealed to in interactions during the dinners (i.e. peer-to-peer contact) and expect peer contact to increase motivation in working on personal goals. Throughout 18 weeks, three patients take it in turns to organise nine biweekly dinners at home with support from a nurse. Having dinner together creates a peer support setting and organizing a dinner offers many naturally occurring opportunities to work on social- and community living skills in patients’ personal environment. Therefore, participants form actionable goals to practice skills that they want to improve.
During the main course of dinner, participants will start off by exchanging positive experiences they had during the past two weeks. The group will then choose an illness-related discussion topic during dessert that afterwards will be discussed in a twenty-minute session. The nurse concludes each meeting by reinforcing the participants for their efforts and reiterating the next dinner appointment. Each dinner takes approximately two hours. During dinner the nurse offers support according to the Guided Peer Support Groups (GPSG) methodology, which is characterised by offering structure and being present, without interfering in conversations between participants.
Skill training is guided by self-set goals in self-management (e.g. cooking, planning, cleaning) and/or social skills (e.g. complimenting, assertiveness, listening). These goals are a common thread in the home-based skill training sessions. Skill-training interventions are strongly individualised and nurses adjust their care in agreement with the participant. Care can be delivered by telephone or face-to-face.
Participants receive home-based skill training (5 sessions) and nurse guided peer support (15 sessions).

Control group: Participants are placed on a waiting list and continue as normal for the 12 months of the study. After the study is complete, they are given the opportunity to participate in the HY intervention.

Follow up takes place at 8 and 12 months and involves questionnaires to assess social contact, mental wellbeing and personal recovery.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Social contact is measured using the Experience Sampling Method (ESM) at nine time points (every six weeks) during the study. Each measurement is four measurements per day for three consecutive days.

Secondary outcome measures

1. Personal recovery is measured using Recovery Assessment Scale at baseline, 8 and 12 months
2. Self-esteem is measured using the Self Esteem Rating Scale (SERS-SF) at baseline, 8 and 12 months
3. Loneliness is measured using the De Jong- Gierveld (DJG) loneliness scale at baseline, 8 and 12 months
4. Self-stigma is measured using the Internalized Stigma of Mental Illness (ISMI) scale at baseline, 8 and 12 months
5. Quality of life is measured using the Short Form (SF-12) health survey at baseline, 8 and 12 months
6. Social functioning is measured using the Communication Skills Questionnaire (CSQ) at baseline, 8 and 12 months
7. Social Network is measured using the Social Network Analysis (SNA) at baseline, 8 and 12 months
8. Psychopathology is measured using the Community Assessment of Psychic Experiences (CAPE) at baseline, 8 and 12 months
9. Functioning is measured using the WHO Assessment of Disability (WHODAS) and the Social Functioning Scale (SFS) (competency), the Global Assessment of Functioning (GAF) and the Personal and Social Performance Scale (PSP) at baseline, 8 and 12 months
10. Social Support is measured using the Functional and Social Support Questionnaire (FSSQ) at baseline, 8 and 12 months
11. Evaluation of the intervention is measured using the effective mechanisms of HY questionnaire and the effective mechanisms of peer support questionnaire at 8 months
12. Health consumption is measured using the health consumption questionnaire at baseline, 8 and 12 months

Overall trial start date

01/09/2016

Overall trial end date

01/09/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of schizophrenia or related disorders
2. Aged 18-65 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Substance dependence (not substance abuse) of alcohol or other drugs in such a way that it will prohibit participation in peer groups
2. Frequent participation in dinners at home with peers and with personal contribution (i.e. cooking)
3. Insufficient command of the Dutch language
4. Unsuitable according to a patients’ clinician. For example: florid psychotic episode or group disturbing behaviour

Recruitment start date

16/02/2017

Recruitment end date

16/02/2018

Locations

Countries of recruitment

Netherlands

Trial participating centre

Lentis Psychiatric Institute
Hereweg 80
Groningen
9725 AG
Netherlands

Trial participating centre

GGZ Drenthe
Dennenweg 9
Assen
9404 LA
Netherlands

Trial participating centre

Dimence
Nico Bolkesteinlaan 1
Deventer
7416 SB
Netherlands

Trial participating centre

GGZ Friesland
Sixmastraat 1
Leeuwarden
8932 PA
Netherlands

Trial participating centre

GGZ Noord Holland Noord
Stationsplein 138
Heerhugowaard
1703 WC
Netherlands

Sponsor information

Organisation

University of Groningen

Sponsor details

Broerstraat 5
Groningen
9712 CP
Netherlands

Sponsor type

University/education

Website

www.rug.nl

Funders

Funder type

Charity

Funder name

Stichting Roos

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of the results in a peer reviewed open access scientific journal.

Intention to publish date

31/12/2020

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes