Mental disorders Mental and Behavioural Disorders
Conditions
Interventions
In a multi-centre, parallel-group cluster randomised controlled trial (cRCT), service users and clinicians in clinical units (as the cluster and unit of randomization) randomly allocated to the experi
Sponsors
Central Institute of Mental Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Service users: 1. Aged between 14 and 64 years 2. Help-seeking for mental health problems and deemed sufficiently unwell to be accepted for specialist mental health treatment 3. In contact with local inpatient, outpatient, or community mental health services at the participating clinical sites 4. Able to provide informed consent Clinicians: 1. Providing care and being the clinician in charge of treatment for included service users in one of the clinical units at the participating clinical sites
Exclusion criteria
Exclusion criteria: Service users: 1. Evidence that psychiatric symptoms are precipitated by an organic cause (incl. a diagnosis of ICD-10 F00-F09) 2. Significant risk to themselves or others 3. Clinical diagnosis of intellectual disability (ICD-10 F70-79) or disorders of psychological development (ICD-10 F80-89) that are sufficiently severe to impair a person’s ability to provide informed consent 4. Medical or psychological contra-indication (as judged by the clinician in charge) 5. Self-reported inability or unwillingness to use a smartphone to collect ESM data 6. Not fluent and literate in German (Germany), Dutch (Belgium), Slovak (Slovakia), or English (Scotland) 7. Short life expectancy/terminal illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient-reported service engagement measured using the Service Attachment Questionnaire at 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinician, researcher-rated, and patient-reported service engagement measured using the Service Engagement Scale (SES) at 2, 6, and 12 months 2. Patient-rated accounts of recovery measured using the Questionnaire about the Process of Recovery (QPR) at 2, 6, and 12 months 3. Patient-rated self-management measured using the Mental Health Self-management Questionnaire (MHSEQ) at 2, 6, and 12 months 4. Patient- and clinician-rating of the extent of shared decision making in clinical encounters measured using the 9-item Shared Decision-Making Questionnaire (SDM-Q-9) at 2, 6, and 12 months 5. Extent to which patient goals are achieved measured using Goal Attainment Scaling (GAS) at 2, 6, and 12 months 6. Patient-rated social functioning measured using the Social Functioning Scale (SFS) at 2, 6, and 12 months 7. Patient-rated loneliness measured using the UCL Loneliness Scale at 2, 6, and 12 months 8. Researcher-rated illness severity and change measured using the Clinical Global Impression (CGI) scale at 2, 6, and 12 months 9. Patient-rated general health measured using the General Health Questionnaire (GHQ-12) at 2, 6, and 12 months 10. Patient-rated quality of life measured using Manchester Short Assessment of Quality of Life (MANSA) at 2, 6, and 12 months 11. Health-related quality of life measured using the EuroQol 5-dimension 5-level questionnaire (EQ-5D-5L) at 2, 6, and 12 months 12. Service use measured using the Client Service Receipt Inventory (CSRI) at 2, 6, and 12 months 13. Reflective Functioning and emotion regulation measured using the Reflective Functioning Scale (RFS) and the Difficulties in Emotion Regulation Scale (DERS) at 2, 6, and 12 months | — |
Countries
Belgium, Germany, Scotland, Slovakia, United Kingdom
Outcome results
None listed