Social Connectedness Group Intervention in Depression (G4H-A)

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

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Groups for Health

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

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG3 6AA
      • Nottinghamshire Healthcare NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm: Groups 4 Health; Social group intervention. The aim is to practice participating in a social group within a safe environment; to identify groups and social networks which are meaningful for the person; and to understand any barriers people may have to engaging with these groups/networks.	Behavioral: Groups for Health; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	The proportion of patients contacted for screening against those who are consented	3 months
Feasibility of enrollment	The proportion of patients consented against those enrolled	3 months
Feasibility of data collection	The overall proportion of survey measures completed by each participant at each of the 2 time points	8 weeks
Patient retention	The proportion of patients attending all five G4H sessions	8 weeks

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Study Chair: Tom Dening, MD, University of Nottingham

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Baker SL, Heinrichs N, Kim HJ, Hofmann SG. The liebowitz social anxiety scale as a self-report instrument: a preliminary psychometric analysis. Behav Res Ther. 2002 Jun;40(6):701-15. doi: 10.1016/s0005-7967(01)00060-2.
• Hays RD, DiMatteo MR. A short-form measure of loneliness. J Pers Assess. 1987 Spring;51(1):69-81. doi: 10.1207/s15327752jpa5101_6.
• Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
• Van Orden KA, Cukrowicz KC, Witte TK, Joiner TE. Thwarted belongingness and perceived burdensomeness: construct validity and psychometric properties of the Interpersonal Needs Questionnaire. Psychol Assess. 2012 Mar;24(1):197-215. doi: 10.1037/a0025358. Epub 2011 Sep 19.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): March 18, 2019
• Study Completion (Actual): March 18, 2019

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: 17110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No