Behavioral Activation for Social Connectedness

Overseen By Renée L Pepin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Depression, Cognitive impairment, Hearing/vision, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

11 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a therapy that helps older adults who feel isolated by encouraging them to do activities they enjoy, aiming to make them happier and more socially connected.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Brief Behavioral Activation for Improving Social Connectedness?

Research shows that modifying Behavioral Activation can effectively reduce loneliness and increase social connectedness in older adults who are homebound. This treatment has also been shown to alleviate depressive symptoms, suggesting it can help improve overall mental well-being. ^{1 2 3 4 5}

Is Behavioral Activation for Social Connectedness safe for humans?

There is limited specific safety data available for Behavioral Activation for Social Connectedness, but generally, behavioral interventions are considered safe as they focus on changing behavior patterns rather than using medications or invasive procedures. ^{6 7 8 9 10}

How does the treatment Brief Behavioral Activation for Improving Social Connectedness differ from other treatments for social isolation and loneliness?

This treatment is unique because it specifically modifies Behavioral Activation, a therapy originally used for depression, to focus on increasing social connectedness and reducing loneliness among older adults. Unlike other interventions, it has been shown to be more effective than friendly visits in improving social connections and reducing depressive symptoms in homebound older adults. ^{1 11 12 13 14}

Research Team

Renée L Pepin, PhD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for older adults over 60 who are part of a home-delivered meals program and feel disconnected socially. It's not for those with significant depression, suicide risk, cognitive issues, severe hearing or vision problems that prevent using tele-conferencing tools, non-English speakers, people unable to consent, minors, pregnant women or prisoners.

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

Adults unable to consent will be excluded

Clinically significant depression (Patient Health Questionnaire; PHQ-9 ≥ 10) or active suicide risk (Columbia Suicide Severity Rating Scale; C-SSRS)

Cognitive Impairment (Blessed Orientation-Memory-Concentration Test>9)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-session Brief Behavioral Activation intervention to improve social connectedness

6 weeks

Follow-up

Participants are monitored for changes in social connectedness 12 weeks post-intervention

12 weeks

Treatment Details

Interventions

• Brief Behavioral Activation for Improving Social Connectedness

Trial Overview The study tests a Brief Behavioral Activation technique aimed at improving social connections among seniors. The effectiveness will be measured by staff from the Area Agency on Aging who work with these individuals.

Participant Groups

Group I: Brief Behavioral Activation for Improving Social Connectedness Experimental Treatment 1 Intervention

Active, 6 session Brief Behavioral Activation for Improving Social Connectedness

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Findings from Research

A modified version of Behavioral Activation, called Brief Behavioral Activation for Improving Social Connectedness, effectively reduced loneliness and depressive symptoms in homebound older adults, as shown in a recent randomized clinical trial.

The intervention, delivered over six weekly sessions by trained non-clinical individuals, shows promise for scalability in programs serving older adults, although further research is needed to confirm its long-term effectiveness and training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifying Behavioral Activation to Reduce Social Isolation and Loneliness Among Older Adults. Pepin, R., Stevens, CJ., Choi, NG., et al.[2022]

The REACH II program, a multi-site trial focused on caregivers of Alzheimer's patients, highlighted the need for tailored safety monitoring and adverse event reporting protocols in psychosocial and behavioral intervention studies, as existing guidelines primarily address medical interventions.

The study identified unique challenges in defining and classifying adverse events, as well as establishing resolution criteria, emphasizing the variability in safety monitoring practices across psychosocial trials and the necessity for standardized protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. Czaja, SJ., Schulz, R., Belle, SH., et al.[2022]

A study involving 1139 participants from a larger trial found that 96% of respondents supported the use of SMS for monitoring vaccine safety after immunization, indicating a strong public acceptance of this method.

While most participants favored SMS surveillance, 62% believed that consent should be obtained beforehand, highlighting a need for addressing privacy concerns and understanding demographic factors that may affect compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization - The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial. Gold, MS., Lincoln, G., Bednarz, J., et al.[2021]

Social media discussions about adverse events (AEs) are increasing, but traditional data sources like the FDA's Adverse Event Reporting System (FAERS) show a greater increase in frequency, indicating that while social media can provide insights, it may not fully replace established pharmacovigilance methods.

The study found that linking posts from the same authors on social media resulted in higher quality medical insights, and actively engaging patients for follow-up information yielded a high response rate, suggesting that social media can enhance the depth of pharmacovigilance data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Patients via Online Healthcare Fora: Three Pharmacovigilance Use Cases. Powell, G., Kara, V., Painter, JL., et al.[2022]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

Visualizing adverse events in clinical trials using methods like dot plots and volcano plots can enhance communication about the severity, timing, and recurrence of harms, rather than just counting occurrences.

The study analyzed individual participant data from a randomized trial of gabapentin for neuropathic pain, demonstrating that effective visualizations can help stakeholders better understand the multidimensional nature of harms in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials. Qureshi, R., Chen, X., Goerg, C., et al.[2022]

The pilot testing of the cooperative card game 'Connections' showed that participants found it enjoyable and helpful in building social connections, with significant reductions in loneliness, depressed mood, and anxiety after playing.

Participants also reported increased enthusiasm for forming new connections and a greater willingness to open up to others, indicating the game's potential to enhance interpersonal relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iterative Design, Feasibility, and Preliminary Efficacy Testing for the Development of a Cooperative Card Game Intervention to Reduce Loneliness and Foster Social Connection. Van Bogart, K., Johnson, JA., Nayman, S., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Modifying Behavioral Activation to Reduce Social Isolation and Loneliness Among Older Adults. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A brief behavioral activation treatment for depression. A randomized pilot trial within an inpatient psychiatric hospital. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Combatting Social Isolation, Anxiety, and Loneliness in Hospitalized Patients: A Quasi-Experimental Study. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Are self-managed online interventions for depression effective in improving behavioral activation? A secondary analysis of a cluster-randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Data and safety monitoring in social behavioral intervention trials: the REACH II experience. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization - The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Engaging Patients via Online Healthcare Fora: Three Pharmacovigilance Use Cases. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Comparing the Value of Data Visualization Methods for Communicating Harms in Clinical Trials. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The UBC State Social Connection Scale: Factor Structure, Reliability, and Validity. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Social Connection as a Public Health Issue: The Evidence and a Systemic Framework for Prioritizing the "Social" in Social Determinants of Health. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Iterative Design, Feasibility, and Preliminary Efficacy Testing for the Development of a Cooperative Card Game Intervention to Reduce Loneliness and Foster Social Connection. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Conceptual framework for social connectedness in mental disorders: Systematic review and narrative synthesis. [2019]