Clinical trial NCT03446963: Social Connectedness Group Intervention in Depression
Official title: Feasibility Study of the Groups for Health Intervention for Adults Accessing Treatment for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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

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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: 3 months
measure: Feasibility of enrollment
timeFrame: 3 months
measure: Feasibility of data collection
timeFrame: 8 weeks
measure: Patient retention
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare NHS Foundation Trust
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Tom Dening, MD
role: STUDY_CHAIR
References:
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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.
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.
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.
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.