Social Connectedness Group Intervention in Depression (G4H-A)
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|ClinicalTrials.gov Identifier: NCT03446963|
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Groups for Health||Not Applicable|
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.
Interventions: group-based behavioural programme
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Feasibility Study of the Groups for Health Intervention for Adults Accessing Treatment for Depression|
|Actual Study Start Date :||October 1, 2018|
|Actual Primary Completion Date :||March 18, 2019|
|Actual Study Completion Date :||March 18, 2019|
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.
- Feasibility of recruitment [ Time Frame: 3 months ]The proportion of patients contacted for screening against those who are consented
- Feasibility of enrollment [ Time Frame: 3 months ]The proportion of patients consented against those enrolled
- Feasibility of data collection [ Time Frame: 8 weeks ]The overall proportion of survey measures completed by each participant at each of the 2 time points
- Patient retention [ Time Frame: 8 weeks ]The proportion of patients attending all five G4H sessions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446963
|Nottinghamshire Healthcare NHS Foundation Trust|
|Nottingham, Nottinghamshire, United Kingdom, NG3 6AA|
|Study Chair:||Tom Dening, MD||University of Nottingham|