Social-LEAF Life Enhancing Activities for Caregivers

Not Applicable

Completed

Conditions: Social Connectedness

Interventions: Behavioral: Social LEAF

Registration Number: NCT05274074

Lead Sponsor: University of Rochester

Brief Summary: This study examines a behavioral intervention to improve social connection and reduce loneliness for caregivers of a loved one with Dementia with Lewy Bodies (DLB).

Detailed Description: The objective of the Social-LEAF study is to examine psychological mechanisms whereby Social LEAF delivered in a group and via video call reduces loneliness and improves positive emotions for older caregivers of loved ones with DLB. This is an 18-month Stage 2 study examining Social LEAF, which is strengths-based and teaches positive coping skills focused on improving social relationships and is delivered remotely in a group format. These two adaptations to the original LEAF intervention are included to provide a more potent means of improving social connection. A pilot phase with up to 20 caregivers (Aim 1) will address these adaptations regarding feasibility, acceptability, and signal for reducing loneliness, with refinements as needed. A second phase (Aims 2 and 3) will involve a randomized trial comparing Social LEAF to control (30 caregivers in each arm) on loneliness (primary outcome), positive affect (mechanism), and social engagement (mechanism). Data will also be collected on acceptability and perceived benefits using mixed methods.

Aim 1 is to refine the LEAF intervention to target social relationships and loneliness.

Aim 2 is to examine feasibility and acceptability of Social LEAF for DLB caregivers.

Aim 3 is to examine efficacy of Social LEAF in reducing loneliness, increasing positive affect, and increasing social engagement.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not a primary care partner of a person with DLB. Is a primary care partner of someone who has not been clinically diagnosed with DLB. Cannot speak English or provide clear and concise consent to the project.
Has not started LEAF procedures at the beginning and has taken part in Aim 1 of the study.
Has started/taken part in the LEAF procedures at the beginning and also has taken part in Aim 1 of the study.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aim 2	Social LEAF	We will be utilizing the Life Enhancing Activities or Caregivers (LEAF) intervention to display that social networks' can be used as a means of reinforcing the positive life skills of the intervention; and that these same skills will enhance social networks, increase mutual satisfaction in social interactions, and boost motivation to reach out to others, thus combatting social isolation.

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcome Measurement Information System (PROMIS )Positive Affect	Week 6	Change in the Patient Reported Outcomes Measurement Information System (PROMIS)- Positive Affect from Baseline to Week 6. This is a 15-item scale measuring momentary positive affective experiences over the past 7 days. It is a five-point Likert-type scale (i.e.,"not at all, a little bit, somewhat, quite a bit, very much") resulting in 15-75 scale. Scores are summed to create a raw score. Individual items are positively skewed with 5 options from "Not at all" to "Very much." Higher scores indicate better positive affect and are a better outcome.

Secondary Outcome Measures

Name	Time	Method
Berkman-Syme Social Network Index	Week 6	Change in the Berkman-Syme Social Network Index from baseline to week 6. This scale is used to measure social isolation and loneliness and includes subjective experiences of connection to contacts. This measure is a questionnaire to assess the type, size, closeness, and frequency of contacts in a respondent's current social network. This index is the sum of four binary items (Married (no = 0; yes = 1); close friends and relatives (0-2 friends and 0-2 relatives = 0; all other scores = 1); group participation (no = 0; yes = 1); participation in religious meetings or services (less than or equal to every few months = 0; greater than or equal to once or twice a month = 1)). The total index range is 0-4 with a higher score indicative of better social network.
Patient Reported Outcome Measurement Information System (PROMIS) Social Isolation	Week 6	Change in the Patient Reported Outcome Measurement Information System (PROMIS)- Social Isolation from baseline to week 6. This scale assesses perceptions of being avoided, excluded, detached, disconnected from by others. The measure has a Likert Scale (1-5 with 1 being Never and 5 being Always). Raw scores were converted to a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Lower scores indicate lesser social isolation and are therefore a better outcome.
Patient Reported Outcome Measurement Information System (PROMIS) Satisfaction Role Activities	Week 6	Change in the PROMIS V 2.0 Satisfaction Role Activities from baseline to week 6. This scale assessed caregivers satisfaction level in their participation in relaxation and leisure activities.The measure has a Likert Scale (1-5 with 1 being Not at all and 5 being Very much). Raw scores were converted to a T-score, a standardized score with a mean of 50 and a standard deviation of 10. Higher scores indicate higher satisfaction and are therefore a better outcome.
Positive Aspects of Caregiving Scale	Week 6	Change in the Positive Aspects of Caregiving Scale from baseline to week 6. This scale consists of nine items assessing positive consequences of caregiving, each rated on a 0-4 Likert scale (range of scores 0-36), where a higher score reflects a more positive perception of the caregiving experience.
University of California Los Angeles (UCLA) Loneliness Scale	Week 6	Change in the UCLA Loneliness scale from baseline to week 6. This scale produces a continuous score of the degree to which participants endorse loneliness. The measure has 20 items with a Likert scale of 1-4 with 1 being Never and 4 being Always resulting in a 20-80 scale. Lower scores indicate better outcome.