N/A
N=30
Engage Psychotherapy to Promote Connectedness in Caregivers
Loneliness · Social Isolation · Caregiver Burnout
Bottom Line
View on ClinicalTrials.gov: NCT04176601 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Loneliness — 48.76; 44.44 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Engage coaching (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Loneliness |
48.76; 44.44 | — |
| PRIMARY Social Functioning |
40.22; 44.92 | — |
| SECONDARY Perceived Social Isolation |
54.61; 50.74 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 50 yrs;
- English speaking;
- Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
- Endorse elevated caregiving distress as measured by a score of greater than 11 on the 10-item Perceived Stress Scale (PSS-10) and/or a score of 5 or greater on the Modified Caregiver Strain Index (MCSI);
- Endorse clinically significant loneliness as measured by a score of greater than 6 on the UCLA Loneliness Scale: Short Form.
Exclusion Criteria
- Primary language is not English;
- Recent or current psychosis;
- Significant cognitive impairment;
- Hearing problems that preclude completion of the intervention.
Data sourced from ClinicalTrials.gov (NCT04176601). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.