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Completed

NCT Number: NCT04176601

Engage Psychotherapy to Promote Connectedness in Caregivers

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.

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Key information

Conditions

Loneliness Behavior Behavioral Symptoms Caregiver Burden Caregiver Burnout Social Behavior Social Isolation Stress, Psychological

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Engage coaching

Behavioral

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.

Primary outcomes

  1. Loneliness

    Time frame: 3 months

    UCLA Loneliness Scale Version 3, which assesses self-reported loneliness. 20 items, rated as to how often the participant has felt a certain way in the prior month (e.g., "How often do you feel alone?") -- "never" (1), "rarely" (2), "sometimes" (3), or "often" (4). Higher scores indicate greater loneliness. However, some individual items must be reverse-coded so that higher total scores reflect greater loneliness (i.e., 1=4, 2=3, 3=2, 4=1). These items (e.g., "How often do you feel there are people you can turn to?") are items 1,5,6,9,10,15,16,19,20. Total scores range from 20 to 80, with higher scores representing a worse outcome (i.e., greater loneliness).

  2. Social Functioning

    Time frame: 3 months

    Satisfaction with Social Roles and Activities (PROMIS) is a computerized adaptive test (CAT). It produces T scores with a mean of 50 and standard deviation of 10. Greater scores indicate better outcomes (i.e., greater satisfaction with social role and activities).

Secondary outcomes

  1. Perceived Social Isolation

    Time frame: 3 months

    PROMIS Perceived Social Isolation Computerized Adaptive Test. This is a computerized adaptive test (CAT) that assessed perceived social isolation. It produces T scores with a mean of 50 and standard deviation of 10. Greater scores indicate worse outcomes (i.e., greater perceived social isolation).

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2019
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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