Social ConnectednessNCT05686681
Connect ME: Improving Social Connectedness
A study testing Brief Behavioral Activation for Improving Social Connectedness in people with Social Connectedness, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Social Connectedness
- What is being tested?
- Brief Behavioral Activation for Improving Social Connectedness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Individuals who are not yet adults (infants, children, teenagers) will be excluded
- Pregnant women will be excluded
- Prisoners will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Improving Social Connectedness in Homebound Older Adults by Integrating a Brief Evidence-Based Telehealth Intervention Into Area Agency on Aging Services
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
- Being tested
- Brief Behavioral Activation for Improving Social Connectedness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Activation for Improving Social ConnectednessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Brief Behavioral Activation for Improving Social Connectedness | Experimental | Active, 6 session Brief Behavioral Activation for Improving Social Connectedness Receives: Behavioral: Brief Behavioral Activation for Improving Social Connectedness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Connectedness A, Baseline
10-item Duke Social Support Index (DSSI)
Measured: before the intervention
Social Connectedness A, Change from Baseline to Post Intervention
10-item Duke Social Support Index (DSSI)
Measured: immediately following the intervention
Social Connectedness A, Change from Post Intervention to Follow Up
10-item Duke Social Support Index (DSSI)
Measured: 12 weeks post intervention
Social Connectedness B, Baseline
8-item PROMIS Social Isolation Scale
Measured: before the intervention
Social Connectedness B, Change from Baseline to Post Intervention
8-item PROMIS Social Isolation Scale
Measured: immediately following the intervention
Social Connectedness B, Change from Post Intervention to Follow Up
8-item PROMIS Social Isolation Scale
Measured: 12 weeks post-intervention
Secondary outcomes (1)
Intervention Reach
Reach will be determined by the proportion of eligible agency clients who agree participate in the study.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 May 2023
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social ConnectednessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renee.L.Pepin, Dartmouth-Hitchcock Medical Center
- Investigators
- Renée L Pepin, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686681
- Sponsor's protocol ID
- STUDY02001734
- Status last verified
- Mar 2025
- First submitted
- 22 Dec 2022
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Social Connectedness in Homebound Older Adults by Integrating a Brief Evidence-Based Telehealth Intervention Into Area Agency on Aging Services
- ClinicalTrials.gov ID
- NCT05686681
- Acronym / sponsor ID
- STUDY02001734
- Conditions
- Social Connectedness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the reach and effectiveness of a behavioral activation intervention for older adults experiencing low social connectedness by Area Agency on Aging Staff.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Behavioral Activation for Improving Social Connectedness | Experimental | Behavioral: Brief Behavioral Activation for Improving Social ConnectednessActive, 6 session Brief Behavioral Activation for Improving Social Connectedness |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Behavioral Activation for Improving Social ConnectednessBrief 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. | Behavioural | Brief Behavioral Activation for Improving Social Connectedness |
Primary outcome
Social Connectedness A, Baseline
Time frame: before the intervention
10-item Duke Social Support Index (DSSI)
Social Connectedness A, Change from Baseline to Post Intervention
Time frame: immediately following the intervention
10-item Duke Social Support Index (DSSI)
Social Connectedness A, Change from Post Intervention to Follow Up
Time frame: 12 weeks post intervention
10-item Duke Social Support Index (DSSI)
Social Connectedness B, Baseline
Time frame: before the intervention
8-item PROMIS Social Isolation Scale
Social Connectedness B, Change from Baseline to Post Intervention
Time frame: immediately following the intervention
8-item PROMIS Social Isolation Scale
Social Connectedness B, Change from Post Intervention to Follow Up
Time frame: 12 weeks post-intervention
8-item PROMIS Social Isolation Scale
1 secondary outcome
Intervention Reach
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renée L Pepin, PhD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Activation for Improving Social Connectedness in people with Social Connectedness, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Connectedness A, Baseline (time frame: before the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.