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Clinical Trials/NCT03446963
NCT03446963
Completed
Not Applicable

Feasibility Study of the Groups for Health Intervention for Adults Accessing Treatment for Depression

University of Nottingham1 site in 1 country29 target enrollmentOctober 1, 2018
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
University of Nottingham
Enrollment
29
Locations
1
Primary Endpoint
Feasibility of data collection
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study evaluates the feasibility of the Groups for Health (G4H) intervention for adults accessing support for depression in the UK. G4H targets improvements in adults' interpersonal functioning in order to reduce feelings of loneliness. The study will adapt the G4H intervention for delivery to adults seeking treatment for depression in the UK and estimate trial parameters (recruitment, retention, missing data and acceptability) of the adapted intervention, prior to a definitive trial. A mixed methods design of interviews and a single group, pre-post study will be employed.

Detailed Description

Background: Loneliness is frequently reported amongst adults with depression. Interventions to reduce loneliness in different populations have shown mixed results. The Groups for Health (G4H) programme has been developed according to the social identity approach within social psychology and has demonstrated preliminary efficacy for reducing loneliness in a proof-of-concept study conducted with Australian student sample. The present study will examine whether G4H can be adapted to suit the needs of a clinical population in the context of UK secondary care services. Objective: Phase 1 - To adapt the G4H intervention for delivery to adults seeking treatment for depression in the UK. Phase 2: To estimate trial parameters (recruitment, retention, missing data and acceptability) of the adapted intervention, prior to a definitive trial; to optimise the adapted intervention for delivery to adults accessing treatment for depression in the UK; to optimise evaluation procedures (candidate outcome measures) Trial configuration: sequential exploratory mixed methods design. Phase 1: one-to-one interviews. Phase 2: Activity 1 (intervention), single group, pre-post study. Activity 2 (interviews): one-to-one interviews. Condition: Depression Interventions: group-based behavioural programme

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
March 18, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Service user participants:
  • Aged 18-65
  • Accessing treatment for depression
  • Loneliness: score 6 or above on the University of California Loneliness Scale (UCLA-3) (Hughes et al., 2004)
  • Able to speak/read English
  • Ability to give informed consent
  • Staff participants:
  • Clinical practitioner with at least 6 months experience of working with people with depression
  • Phase 2 Activity 1: intervention
  • Aged 18-65

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Feasibility of data collection

Time Frame: 8 weeks

The overall proportion of survey measures completed by each participant at each of the 2 time points

Feasibility of recruitment

Time Frame: 3 months

The proportion of patients contacted for screening against those who are consented

Patient retention

Time Frame: 8 weeks

The proportion of patients attending all five G4H sessions

Feasibility of enrollment

Time Frame: 3 months

The proportion of patients consented against those enrolled

Study Sites (1)

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