Loneliness Clinical Trial
— SEPOfficial title:
Building Supportive Social Networks to Advance the Mental Health of Women Affected by Violence in Vancouver's Downtown East Side
Verified date | November 2023 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this study is to test a pilot intervention aimed at improving social connectedness among women affected by gender-based violence in a resource-restricted, urban context. The intervention will specifically address barriers to building and sustaining supportive social networks to reduce women's risks for worsening mental health associated with isolation, with a focus on barriers stemming from gender-based violence and poverty. The main question it aims to answer are: - How acceptable is the intervention to women affected by gender-based violence including the benefits, burdens and appropriateness in the context of their everyday lives? - How feasible is the intervention and study protocol? - What are the effects of a peer-led social engagement intervention to develop and sustain supportive social networks and reduce isolation among women affected by gender-based violence? Participants will engage in social activities with trained peer workers over a one-year period.
Status | Enrolling by invitation |
Enrollment | 75 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18 years or older; 2. Self-identify as a woman (trans-inclusive); 3. Able to verbally communicate in English; 4. Have a consistent place to live that is not a temporary shelter; 5. Have lived in the same place for at least one month; 6. Live and/or spend significant time for work and/or health and social services in the study catchment area 7. Able and willing to provide adequate contact information Age 18 or over 8. Willing and able to provide consent Exclusion Criteria: 1. planning to travel away from the study catchment area for a time period that would interfere with study participation; 2. is experiencing a condition that, in the opinion of the site PI, would preclude informed consent or make study participation unsafe. |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Inner-City Women's Initiatives Society, Vancouver Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acceptability of the intervention - qualitative data from participants | Acceptability measures include qualitative reports of intervention acceptability among participants. These will include in-depth interviews to explore goals and rationale for enrolling in the intervention as well as expectations and perspectives about initial social engagement activities | 2 months | |
Primary | Acceptability of the intervention - qualitative data from participants | Acceptability measures include qualitative reports of the intervention acceptability among participants. Upon intervention completion, in-depth qualitative interviews covering topics such as satisfaction with the content, length, and delivery of the intervention as well as reported impact on participants' life | 12 months | |
Primary | Acceptability of the intervention - quantitative data from participants [survey tool] | Satisfaction with intervention content,delivery, length, using a survey tool and measured on a likert scale response 1 to 5 with higher indicating higher satisfaction and as open ended response options | 6 months | |
Primary | Acceptability of the intervention - quantitative data from participants [survey tool] | Satisfaction with intervention content,delivery, length, using a survey tool and measured on a likert scale response 1 to 5 with higher indicating higher satisfaction an as open ended responses | 12 months | |
Primary | Acceptability of intervention - qualitative data from peer workers | Acceptability measures include qualitative reports of the intervention acceptability among peer support workers. These will include in-depth qualitative interviews about the delivery and length of the intervention. | 3 months | |
Primary | Acceptability of intervention - qualitative data from peer workers | Acceptability measures include qualitative reports of the intervention acceptability among peer support workers. These will include in-depth qualitative interviews | 12 months | |
Primary | Acceptability of the intervention - qualitative data from staff | Acceptability measures include qualitative reports of the intervention acceptability among peer support workers. These will include in-depth qualitative interviews about the implementation process, the content, timing and delivery of the intervention. | 12 months | |
Primary | Feasibility of the intervention - Retention - forms | proportion of participants who complete initial enrollment, retention is >75% at 12 months | 12 months | |
Primary | Feasibility of the intervention - process fidelity - forms | observations of intervention delivery capturing activities administered; | throughout the study; 12 months | |
Primary | Feasibility of the intervention - financial cost - forms | calculated total cost for intervention activities; total cost calculated using cash amounts for salaries of providers and intervention activities. Time frame. 12 months | 12 months | |
Primary | Feasibility of the Intervention - qualitative data from staff | Feasibility includes qualitative reports of the strengths and challenges experienced implementing a behavioural intervention in a community setting. In-depth interviews with staff will explore the specific experiences of implementing peer-led initiatives with women affected by violence who are living in extreme poverty and experience numerous physical and mental health challenges. | 12 months | |
Secondary | Social Connectedness - survey tool | Self-report experiences of social connectedness in the past 3 months using questions about frequency of social activities with others (total number experienced), sense of belonging in community (likert scale response with higher being greater sense of belonging), and perceived social support with questions about the quality of relationships with others (likert scale with lower score indicating higher quality). | 2 weeks | |
Secondary | Social Connectedness - survey tool | Self-report experiences of social connectedness in the past 3 months using questions about frequency of social activities with others in the past 3 months (total number experienced), sense of belonging in community (likert scale response with higher being greater sense of belonging), and perceived social support with questions on questions about the quality of relationships with others (likert scale with lower score indicating higher quality). | 6 months | |
Secondary | Social Connectedness - survey tool | Self-report experiences of social connectedness in the past 3 months using questions about frequency of social activities with others in the past 3 months (total number experienced), sense of belonging in community (likert scale response with higher being greater sense of belonging), and perceived social support with questions on questions about the quality of relationships with others (likert scale with lower score indicating higher quality). | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04164654 -
A Mobile App to Address Student Loneliness
|
N/A | |
Recruiting |
NCT05831475 -
LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation
|
N/A | |
Completed |
NCT05490979 -
The Impact of Dyad Exercises on Well-being and Connection in Young Adults
|
N/A | |
Not yet recruiting |
NCT05054660 -
Applying a Chatbot to Geriatric Patients in Psychiatric Clinics: A Pilot Study
|
N/A | |
Enrolling by invitation |
NCT04137432 -
Oxytocin-augmented Cognitive-behavioral Group-based Short-term Intervention for Loneliness
|
Phase 1 | |
Not yet recruiting |
NCT05423899 -
Humanoid Robot vs Treatment as Usual for Loneliness
|
N/A | |
Active, not recruiting |
NCT05678985 -
Evaluating Impact and Implementation of Choose to Move (Phase 4)
|
N/A | |
Withdrawn |
NCT04797026 -
Penpal Loneliness Project
|
N/A | |
Completed |
NCT06018974 -
Digital Gaming Intervention for Older People in Long-term Care
|
N/A | |
Not yet recruiting |
NCT06424483 -
Love Group for Geriatric Psychiatry Outpatients
|
N/A | |
Enrolling by invitation |
NCT06434298 -
Provincial Scale-up of Choose to Move (CTM) Phase 4
|
N/A | |
Recruiting |
NCT05520450 -
Telematic Support Group in Patients With Feelings of Loneliness and Social Isolation
|
||
Not yet recruiting |
NCT05450445 -
myHealthHub for Older Adult Inpatients
|
N/A | |
Active, not recruiting |
NCT05646329 -
The Effect of Motivational Interviewing on Problematic Internet Use and Loneliness
|
N/A | |
Completed |
NCT04682535 -
Daily Study of Caregiving Relationships and Health
|
||
Recruiting |
NCT04301167 -
Loneliness and Health: The Moderating Role of Befriending Services
|
N/A | |
Completed |
NCT03124446 -
Mindfulness-Based College: Stage 1
|
N/A | |
Recruiting |
NCT04733300 -
Online Mindfulness-Based College for Young Adults
|
N/A | |
Completed |
NCT04907942 -
Feasibility and Acceptability of Click's EMA and Text Message Intervention for STRESS Management
|
Phase 1/Phase 2 | |
Recruiting |
NCT05812989 -
Modifiers and Mechanisms of Loneliness Interventions
|
N/A |