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Table 1 SPIRIT schedule of enrolment, interventions, and assessments for participants

From: The Community Navigator Study: a feasibility randomised controlled trial of an intervention to increase community connections and reduce loneliness for people with complex anxiety or depression

 

Study period

Timepoint

Enrolment

Allocation

Treatment period (6 months)

Follow-up (end of treatment period; 6 months)

Enrolment:

 Eligibility screen

X

   

 Informed consent

X

   

 Randomisation

 

X

  

Intervention:

 Community Navigation

  

X

 

 Control

  

X

 

Assessments:

 Baseline outcome measures

X

   

 Sociodemographic characteristics

 Trust Informatics information

 De Jong Gierveld Loneliness Scale

 Lubben Social Network Scale

 Resource Generator UK

 Time Budget Diary

 WEMWBS

 Patient Health Questionnaire

 Generalised Anxiety Disorder Questionnaire

 EQ-5D-5 L

 Recovering Quality of Life Questionnaire

Process recording

  

X

 

 Community Navigator session logs

 Participant feedback phone calls

Follow-up outcome measures

   

X

 Sociodemographic characteristics

 Trust Informatics information

 De Jong Gierveld Loneliness Scale

 Lubben Social Network Scale

 Resource Generator UK

 Time Budget Diary

 WEMWBS

 Patient Health Questionnaire

 Generalized Anxiety Disorder Questionnaire

 EQ-5D-5 L

 Recovering Quality of Life Questionnaire

Qualitative interview

  

X

X

  1. WEMWBS Warwick-Edinburgh Mental Well-being Scale, EQ-5D-5 L EuroQol 5-dimension, 5-level health outcome measure