Loneliness Clinical Trial
Official title:
Engage Psychotherapy to Promote Connectedness in Caregivers: A Pilot Study of the Rochester Roybal Center for Social Ties and Aging Research
The Engage Coaching Project is a Stage 1 intervention development study. This study asks: "what behavioral strategies are needed to help socially disconnected caregivers with significant barriers to increasing connectedness?" This study uses a mixed methods approach to adapt a brief behavioral intervention-Social Engage psychotherapy-for use with socially disconnected caregivers. The ultimate goal is for Social Engage psychotherapy to be offered as a second step in a stepped care approach for caregivers who do not demonstrate an adequate response to a single-session psychoeducation plus resources intervention. Social Engage Psychotherapy helps caregivers bolster motivation for increasing connectedness, teaches problem solving skills, and provides behavioral practice with social engagement. Up to 8 brief sessions (typically 30 minutes) are provided weekly over no more than three months. This is a single-arm clinical trial of Social Engage psychotherapy, with up to 30 participants.
This is a Stage 1 intervention development study. This study asks: "what behavioral strategies are needed to help socially disconnected caregivers with significant barriers to increasing connectedness?" Pilot 2 uses a mixed methods approach to adapt a brief behavioral intervention-Social Engage psychotherapy-for use with socially disconnected caregivers, which we call Engage Coaching for Caregivers. The ultimate goal is for Engage Coaching for Caregivers to be offered as a second step in a stepped care approach for caregivers who do not demonstrate an adequate response to a single-session psychoeducation plus resources intervention. Engage Coaching helps caregivers bolster motivation for increasing connectedness, teaches problem solving skills, and provides behavioral practice with social engagement. Up to 8 brief sessions (typically 30 minutes) are provided weekly over no more than three months. This is a single-arm clinical trial with up to 30 participants. The study's primary objective is to discover the most useful strategies to promote social connectedness in the context of caregiving. Participants will complete up to 8 weekly individual Engage Coaching sessions via phone or Zoom. Participants will be allotted up to 3 months to complete all sessions, a time-frame that allows for two weeks without meeting to address life stressors such as illnesses that may pop up. The first and last session are longer - up to 60 minutes if needed. Middle sessions are shorter (20-45 minutes). Engage is a stepped care psychotherapy in that the simplest strategy is taught first-action planning (a derivative of problem solving therapy)-and "barrier strategies" are added only if needed. Coaches and the PI will work together to devise caregiver specific barrier strategies as needed, such as brief communication skills coaching or education on behavioral issues in dementia. The development and piloting of these new caregiver specific barrier strategies is a key objective of this pilot study. During the data analysis phase, we will conduct qualitative analyses from participants on which of these strategies were most useful and combined with experiences from therapists, we will adapt the therapy manual to include the most useful strategies, for testing in a subsequent Stage II efficacy trial. ;
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 |