CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Engage coachingbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04176601
NCT04176601N/ACompleted

Engage Psychotherapy to Promote Connectedness in Caregivers: A Pilot Study of the Rochester Roybal Center for Social Ties and Aging Research

University of Rochester·interventional·Posted Nov 25, 2019·Updated Feb 25, 2025

In Brief

A clinical study evaluating Engage coaching for Loneliness and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 25, 2019
Enrollment StartJul 8, 2020
Primary CompletionJun 30, 2021
Study CompletionOct 31, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.6 years ago

Interventions

Engage coachingbehavioral

Participants will complete up to 8 weekly individual Social Engage psychotherapy sessions. 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. All sessions are provided via phone or videocall (Zoom). 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. Action plans are designed to address loneliness and social isolation in the context of caregiving demands.