Depression Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 03/02/2026:
This is a researcher-blind, randomised controlled trial with two arms. Staff in participating NHS services will briefly describe the study to potentially elig
then take formal consent from those who wish to take part. All consenting, potential participants will then be screened by researchers for loneliness and meeting treatment resistant depression criteri
Sponsors
Camden and Islington NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age 18+ years 2. Meet ICD-10 diagnostic criteria for depression assessed using the Clinical Interview Schedule - Revised (CIS-R) interview 3. Have had at least two reported courses of anti-depressants without symptom remission, confirmed by the participant 4. Score of 2 or more on 6-item De Jong Gierveld Loneliness Scale (DJG-6)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 28/11/2024: 1. Are due to be discharged from the mental health team within the trial intervention period (8 months) 2. Currently using mental health inpatient services 3. Identified by involved clinicians or clinical records as having a primary diagnosis of a serious mental illness other than TRD, defined as schizophrenia or other non-mood psychotic disorders (ICD-10 codes F20-29 or equivalent) or bipolar disorder (ICD-10 code F31 or equivalent), or a diagnosis of dementia (ICD-10 codes F00-F03 or equivalent) or mild cognitive impairment (ICD-10 code F06.7 or equivalent) 4. Lacks capacity to consent to participate 5. Does not understand English well enough to give informed consent and engage with the study intervention 6. Has a care coordinator who supervises the Community Navigators _____ Previous exclusion criteria: 1. Are due to be discharged from the mental health team within the trial intervention period (8 months) 2. Currently using mental health inpatient services 3. Identified by involved clinicians or clinical records as having a primary diagnosis of a serious mental illness other than TRD, defined as schizophrenia or other non-mood psychotic disorders (ICD codes F20-29) or bipolar disorder (ICD code F31) 4. Lacks capacity to consent to participate 5. Does not understand English well enough to give informed consent and engage with the study intervention 6. Has a care coordinator who supervises the Community Navigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression severity (PHQ-9) at 8 months (end-of-treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression severity (PHQ-9); Timepoint(s): baseline, 4, 11, and 14 months 2. Number of patients achieving a 20% reduction in PHQ-9; Timepoint(s): Baseline, 8 and 14 months 3. Number of patients who achieve remission of depressive symptoms, defined as a PHQ-9 score of <10; Timepoint(s): Baseline, 8 and 14 months 4. Loneliness (ULS-8); Timepoint(s): Baseline, 4, 8, 11, and 14 months 5. Anxiety (GAD-7); Timepoint(s): Baseline, 8 and 14 months 6. Process of Recovery (QPR); Timepoint(s): Baseline, 8 and 14 months 7. Four-item Multiple Identities Scale (MIS); Timepoint(s): Baseline, 8 and 14 months 8. Brief Rosenberg self-esteem scale (B-RSES); Timepoint(s): Baseline, 8 and 14 months 9. Self-stigma (DISC-12 sub-scale); Timepoint(s): Baseline, 8 and 14 months 10. Lubben Social Network Schedule (LSNS-6); Timepoint(s): Baseline, 8 and 14 months 11. EuroQol EQ-5D 5 level (EQ-5D-5L); Timepoint(s): Baseline, 8 and 14 months 12. Recovering Quality of Life (ReQoL); Timepoint(s): Baseline, 8 and 14 months 13. Client Service Inventory (CSRI); Timepoint(s): Baseline, 8 and 14 months 14. Daytime Activities Questionnaire; Timepoint(s): Baseline, 4, 8, 11, and 14 months | — |
Countries
England, United Kingdom
Outcome results
None listed