Social Connectedness Group Intervention in Depression

NCT03446963 | Completed

• 1 other identifier: 17110
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Single arm: Groups 4 Health

EXPERIMENTAL

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

Interventions

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.

Single arm: Groups 4 Health

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, Nottinghamshire, NG3 6AA, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 12051488 BACKGROUND

• Hays RD, DiMatteo MR. A short-form measure of loneliness. J Pers Assess. 1987 Spring;51(1):69-81. doi: 10.1207/s15327752jpa5101_6.

  PMID: 3572711 BACKGROUND

• 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.

  PMID: 18504506 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 21928908 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Population Groups; Health

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Tom Dening, MD

  University of Nottingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 27, 2018
• Study Start: October 1, 2018
• Primary Completion: March 18, 2019
• Study Completion: March 18, 2019
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

GB (1)