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Completed

NCT Number: NCT03446963

Social Connectedness Group Intervention in Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, Nottinghamshire, NG3 6AA, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Phase 1

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
  • 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

Activity 2: interviews

  • Attended or agreed to attend Phase 2, Activity 1

Exclusion criteria

  • None

Treatment and study plan

Groups for Health

Behavioral

Group sessions, 5 modules x 1.5 hours (once per week). Modules focus on psychoeducation, mapping existing social networks, examining barriers to engagement in existing networks, goal setting and identifying new groups to join.

Primary outcomes

  1. Feasibility of recruitment

    Time frame: 3 months

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

  2. Feasibility of enrollment

    Time frame: 3 months

    The proportion of patients consented against those enrolled

  3. 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

  4. Patient retention

    Time frame: 8 weeks

    The proportion of patients attending all five G4H sessions

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Acronym: G4H-A

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 27, 2018
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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