Social Connectedness Group Intervention in Depression

Depression Clinical Trial

— G4H-A  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446963
• Other study ID #: 17110
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 18, 2019

Study information

• Verified date: April 2019
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Nottinghamshire Healthcare NHS Foundation Trust	Nottingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Hays RD, DiMatteo MR. A short-form measure of loneliness. J Pers Assess. 1987 Spring;51(1):69-81. — View 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. — View 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. — View 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. — View Citation

Outcome

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