Specialty: Mental Health, Primary sub-specialty: Study not assigned to a MH Clinical Studies Group
Conditions
Interventions
Participants are randomised to one of two groups. Randomisation will be conducted by an independent statistician in the UCL Division of Psychiatry, who is not connected to the study team. Allocation o
the person’s existing strengths and interests
potential areas where new activity, social connection or support would be of interest
and any current barriers to pursuing these
2. Support to develop and use an action plan to increase connectedness. This will be person centred and include: providing information about
practical help to access activity
access to financial support from a budget
emotional support to overcome barriers to increasing social connectedness
3. Participants will be invited to attend up to three meetings for all participants
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Current male and female service users of participating services (Camden and Islington Complex Depression Anxiety and Trauma Team or the Mood Anxiety and Personality Stream of the Barnet Complex Care Team) 2. Aged 18 or over (there is no upper age limit for this study) 3. Service users currently receiving multi-disciplinary support (e.g. care co-ordination and medical input, and access to psychology support) will be prioritised to help explore whether community navigation support is a useful addition within these services
Exclusion criteria
Exclusion criteria: 1. Lacks capacity to consent to participate; 2. Poses a risk of harm to others such that meetings with a researcher or community navigator are not advised by staff from participating clinical services; 3. Is unable to communicate in English; 4. Is currently an inpatient at a mental health or general hospital; 5. Do not meet a threshold level for loneliness on a brief screening questionnaire.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility measures: 1. Recruitment duration is recorded as the time period from recruitment of the first trial participant to meeting the trial recruitment target (40 participants) 2. Recruitment rate is recorded as the number of participants screened, the number of those screened who are eligible, and the number of eligible participants who consent to participate in the study by four months 3. Attrition rate is recorded as the number of participants who consent to participate that remain in the study until the end of follow up at six months 4. Number of adverse events recorded in each study arm until the end of follow up at six months 5. Intervention take-up rate for those in the intervention arm, where the minimum threshold for intervention take-up is three sessions with a Community Navigator 6. Implementation of the intervention is recorded as the proportion of participants that maintained engagement with a Community Navigator and the number of sessions of support provided 7. Process evaluation is undertaken through qualitative interviews at the end of treatment with treatment group participants, Community Navigators and other stakeholders as well as Community Navigators’ records of sessions and feedback from treatment group participants after two of their sessions with a Community Navigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Potential primary and secondary outcomes for a future definitive RCT are being measured to assess acceptability, response and completeness: 1. Loneliness is measured using the de Jong Gierveld loneliness scale (11 items) at baseline and six months 2. Depression severity is measured using the Patient Health Questionnaire (PHQ-9) at baseline and six months 3. Anxiety severity is measured using the Generalized Anxiety Disorder Questionnaire (GAD-7) at baseline and six months 4. Social network is assessed with the abbreviated Lubben Social Network Scale (LSNS-6) at baseline and six months 5. Social capital is measured with the Resource Generator UK (RG-UK) at baseline and six months 6. Activity over the previous week is measured using the Time Budget Diary, with additional questions on whether activities were done with others or alone and, if with others, whether this was online or face-to-face at baseline and six months 7. Wellbeing is measured with the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) at baseline and six months 8. Health-related quality of life is measured with the EQ-5D-5L at baseline and six months 9. Mental health-related quality of life is assessed on the Recovering Quality of Life Questionnaire brief version (ReQoL-10) at baseline and six months 10. Information is sought from Trust Informatics teams regarding participants’ current diagnosis, care cluster, attended and missed face-to-face appointments with their clinical team, use of other community mental health services, admission to acute care, days in inpatient care over previous six months, and use of the Mental Health Act. These records are sought for the six months prior to baseline and at six month follow up for the intervention period since baseline. 11. Records of participants’ use of social care services are sough | — |
Countries
England, United Kingdom
Outcome results
None listed