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Completed

NCT Number: NCT05686681

Connect ME: Improving Social Connectedness

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

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Key information

Conditions

Social Connectedness

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)
  • Clients will meet exclusion criteria for a positive response to any item
  • 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

Treatment and study plan

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):

  • Psychoeducation: Psychoeducation focused on homebound status, social connectedness, and associated changes in behavior.
  • Behavioral Activation intervention rationale: Framing how changing behavior can positively impact social connectedness (i.e., improve social connectedness and reduce loneliness).
  • 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.
  • 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.

Primary outcomes

  1. Social Connectedness A, Baseline

    Time frame: before the intervention

    10-item Duke Social Support Index (DSSI)

  2. Social Connectedness A, Change from Baseline to Post Intervention

    Time frame: immediately following the intervention

    10-item Duke Social Support Index (DSSI)

  3. Social Connectedness A, Change from Post Intervention to Follow Up

    Time frame: 12 weeks post intervention

    10-item Duke Social Support Index (DSSI)

  4. Social Connectedness B, Baseline

    Time frame: before the intervention

    8-item PROMIS Social Isolation Scale

  5. Social Connectedness B, Change from Baseline to Post Intervention

    Time frame: immediately following the intervention

    8-item PROMIS Social Isolation Scale

  6. Social Connectedness B, Change from Post Intervention to Follow Up

    Time frame: 12 weeks post-intervention

    8-item PROMIS Social Isolation Scale

Secondary outcomes

  1. Intervention Reach

    Time frame: 12 Months

    Reach will be determined by the proportion of eligible agency clients who agree participate in the study.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

Improving Social Connectedness in Homebound Older Adults by Integrating a Brief Evidence-Based Telehealth Intervention Into Area Agency on Aging Services

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2023
Registry last updated
Apr 3, 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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