Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Social Connectedness Group Intervention in Depression (G4H-A)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03446963
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Groups for Health Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Feasibility of recruitment [ Time Frame: 3 months ]
    The proportion of patients contacted for screening against those who are consented

  2. Feasibility of enrollment [ Time Frame: 3 months ]
    The proportion of patients consented against those enrolled

  3. 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

  4. Patient retention [ Time Frame: 8 weeks ]
    The proportion of patients attending all five G4H sessions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United Kingdom
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, Nottinghamshire, United Kingdom, NG3 6AA
Sponsors and Collaborators
University of Nottingham
Investigators
Layout table for investigator information
Study Chair: Tom Dening, MD University of Nottingham
Publications:
Layout table for additonal information
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03446963    
Other Study ID Numbers: 17110
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders