Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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10 July 2023 |
Main ID: |
ISRCTN14282228 |
Date of registration:
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31/01/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Hospitality project (HY): Combining peer support and home-based skill training in people with schizophrenia
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Scientific title:
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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 |
Date of first enrolment:
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16/02/2017 |
Target sample size:
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84 |
Recruitment status: |
Completed |
URL:
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https://www.isrctn.com/ISRCTN14282228 |
Study type:
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Interventional |
Study design:
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Multi-centre randomised wait-list controlled trial (Quality of life)
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Phase:
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Not Applicable
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Jelle Sjoerd
Vogel |
Address:
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Lentis Psychiatric Institute
Hereweg 80
9725 AG
Groningen
Netherlands |
Telephone:
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+31 647 327 668 |
Email:
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js.vogel@lentis.nl |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Diagnosis of schizophrenia or related disorders 2. Aged 18-65 years
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia and related psychotic disorders Mental and Behavioural Disorders Schizophrenia and related psychotic disorders
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Intervention(s)
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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 accor
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Primary Outcome(s)
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Current primary outcome measure as of 28/06/2023: Personal recovery is measured using Recovery Assessment Scale at baseline, 8 and 12 months
Previous primary outcome measure: 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.
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Secondary Outcome(s)
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Current secondary outcome measures as of 28/06/2023: 1. Self-esteem is measured using the Self Esteem Rating Scale (SERS-SF) at baseline, 8 and 12 months 2. Loneliness is measured using the De Jong- Gierveld (DJG) loneliness scale at baseline, 8 and 12 months 3. Self-stigma is measured using the Internalized Stigma of Mental Illness (ISMI) scale at baseline, 8 and 12 months 4. Quality of life is measured using the Short Form (SF-12) health survey at baseline, 8 and 12 months 5. Social functioning is measured using the Communication Skills Questionnaire (CSQ) at baseline, 8 and 12 months 6. Social Network is measured using the Social Network Analysis (SNA) at baseline, 8 and 12 months 7. Psychopathology is measured using the Community Assessment of Psychic Experiences (CAPE) at baseline, 8 and 12 months 8. 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 9. Social Support is measured using the Functional and Social Support Questionnaire (FSSQ) at baseline, 8 and 12 months 10. Evaluation of the intervention is measured using the effective mechanisms of HY questionnaire and the effective mechanisms of peer support questionnaire at 8 months 11. Health consumption is measured using the health consumption questionnaire at baseline, 8 and 12 months
Previous 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
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Secondary ID(s)
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2014.479. METC Groningen
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Source(s) of Monetary Support
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Stichting Roos
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Ethics review
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Status:
Approval date:
Contact:
Old ethics approval format; 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).
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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31/10/2020 |
URL:
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