The Community Navigator trial to reduce loneliness and depression in adults with depression that does not respond to drug treatment

Not Applicable

• Conditions: Depression; Mental and Behavioural Disorders

• Registration Number: ISRCTN13205972
• Lead Sponsor: Camden and Islington NHS Foundation Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37803385/ (added 10/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-08
• Last Update Posted: 23 October 2023
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 306

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression severity (PHQ-9) at 8 months (end-of-treatment)