Clinical trial NCT04176601: Engage Psychotherapy to Promote Connectedness in Caregivers
Official title: Engage Psychotherapy to Promote Connectedness in Caregivers: A Pilot Study of the Rochester Roybal Center for Social Ties and Aging Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Social Isolation
Caregiver Burnout
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-11-25
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 50 yrs;
2. English speaking;
3. Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
4. 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);
5. Endorse clinically significant loneliness as measured by a score of greater than 6 on the UCLA Loneliness Scale: Short Form.

Exclusion Criteria:

1. Primary language is not English;
2. Recent or current psychosis;
3. Significant cognitive impairment;
4. Hearing problems that preclude completion of the intervention.

Primary outcomes:
measure: Loneliness
timeFrame: 3 months
measure: Social Functioning
timeFrame: 3 months
Secondary outcomes:
measure: Perceived Social Isolation
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kimberly A Van Orden, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Orden KA, Bower E, Lutz J, Silva C. Engage coaching for caregivers: a pilot trial to reduce loneliness in dementia caregivers. Aging Ment Health. 2023 Sep-Oct;27(10):2019-2026. doi: 10.1080/13607863.2023.2187345. Epub 2023 Mar 10.