search
Back to results

Social Connectedness Group Intervention in Depression (G4H-A)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Groups for Health
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nottinghamshire Healthcare NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm: Groups 4 Health

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 14, 2018
Last Updated
April 24, 2019
Sponsor
University of Nottingham
search

1. Study Identification

Unique Protocol Identification Number
NCT03446963
Brief Title
Social Connectedness Group Intervention in Depression
Acronym
G4H-A
Official Title
Feasibility Study of the Groups for Health Intervention for Adults Accessing Treatment for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
March 18, 2019 (Actual)
Study Completion Date
March 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm: Groups 4 Health
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Groups for Health
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of recruitment
Description
The proportion of patients contacted for screening against those who are consented
Time Frame
3 months
Title
Feasibility of enrollment
Description
The proportion of patients consented against those enrolled
Time Frame
3 months
Title
Feasibility of data collection
Description
The overall proportion of survey measures completed by each participant at each of the 2 time points
Time Frame
8 weeks
Title
Patient retention
Description
The proportion of patients attending all five G4H sessions
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Dening, MD
Organizational Affiliation
University of Nottingham
Official's Role
Study Chair
Facility Information:
Facility Name
Nottinghamshire Healthcare NHS Foundation Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG3 6AA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
12051488
Citation
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.
Results Reference
background
PubMed Identifier
3572711
Citation
Hays RD, DiMatteo MR. A short-form measure of loneliness. J Pers Assess. 1987 Spring;51(1):69-81. doi: 10.1207/s15327752jpa5101_6.
Results Reference
background
PubMed Identifier
18504506
Citation
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.
Results Reference
background
PubMed Identifier
11556941
Citation
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.
Results Reference
background
PubMed Identifier
21928908
Citation
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.
Results Reference
background

Learn more about this trial

Social Connectedness Group Intervention in Depression

We'll reach out to this number within 24 hrs