Connect ME: Improving Social Connectedness

NCT05686681 | Completed

• 1 other identifier: STUDY02001734
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the reach and effectiveness of a behavioral activation intervention for older adults experiencing low social connectedness by Area Agency on Aging Staff.

Conditions

Social Connectedness

Outcome Measures

Primary Outcomes (6)

• Social Connectedness A, Baseline

  10-item Duke Social Support Index (DSSI)

  before the intervention

• Social Connectedness A, Change from Baseline to Post Intervention

  10-item Duke Social Support Index (DSSI)

  immediately following the intervention

• Social Connectedness A, Change from Post Intervention to Follow Up

  10-item Duke Social Support Index (DSSI)

  12 weeks post intervention

• Social Connectedness B, Baseline

  8-item PROMIS Social Isolation Scale

  before the intervention

• Social Connectedness B, Change from Baseline to Post Intervention

  8-item PROMIS Social Isolation Scale

  immediately following the intervention

• Social Connectedness B, Change from Post Intervention to Follow Up

  8-item PROMIS Social Isolation Scale

  12 weeks post-intervention

Secondary Outcomes (1)

• Intervention Reach

  12 Months

Study Arms (1)

Brief Behavioral Activation for Improving Social Connectedness

EXPERIMENTAL

Active, 6 session Brief Behavioral Activation for Improving Social Connectedness

Behavioral: Brief Behavioral Activation for Improving Social Connectedness

Interventions

Brief Behavioral Activation for Improving Social Connectedness BEHAVIORAL

Brief Behavioral Activation for Improving Social Connectedness (BBAISC): BBAISC was developed to address social connectedness. Grounded in Behavioral Activation (Lejuez et al., 2011), BBAISC is a structured, 6-session skill-building intervention that has 4 key elements (Pepin et al., 2020): 1. Psychoeducation: Psychoeducation focused on homebound status, social connectedness, and associated changes in behavior. 2. Behavioral Activation intervention rationale: Framing how changing behavior can positively impact social connectedness (i.e., improve social connectedness and reduce loneliness). 3. Exploration of life areas, values, and activities: Focused on identifying life areas and values most relevant to the participant. Then, these values are used to generate activities that are aligned with those values. 4. Activity monitoring and planning: Participants are encouraged to schedule and organize their day based on what is important rather than their current mood or feeling state.

Brief Behavioral Activation for Improving Social Connectedness

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults (age\>60) will be enrolled because they are the target population served by the home-delivered meals program and the target sample for this study.

You may not qualify if:

• Clinically significant depression (Patient Health Questionnaire; PHQ-9 ≥ 10) or active suicide risk (Columbia Suicide Severity Rating Scale; C-SSRS), or Cognitive Impairment (Blessed Orientation-Memory-Concentration Test\>9)
• Clients who score 1 or greater on question 9 of the PHQ-9 will be further assessed for suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS)
• We will exclude older adults with uncorrectable hearing or vision impairment rendering them unable to use the tele-conferencing equipment.
• Those who cannot speak English and have impaired decision-making capacity
• Adults unable to consent will be excluded
• Individuals who are not yet adults (infants, children, teenagers) will be excluded
• Pregnant women will be excluded
• Prisoners will be excluded

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Study Officials

• Renée L Pepin, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 17, 2023
• Study Start: May 1, 2023
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)